Links to 1395 Entry-Level Biotechnology & Life Science Jobs

10x is seeking an outstanding Research Associate to join work on the rapid prototyping and testing of critical 10x reagents. This individual will be involved in developing and validating consumables for the rapid expansion of 10x product lines. This role requires excellent laboratory skills and attention to detail with demonstrated success in executing operations consistently. Individuals applying for this position must be self-starters, strategic thinkers, action driven, flexible in changing direction and methods, thrive in a fast-paced environment, excel at managing multiple priorities, succeed in communicating with all levels within the organization and provide immediate contribution. etc.

Reporting to the Upstream Supervisor, you will execute cell culture and/or solution prep unit operations in cGMP clinical pilot manufacturing plant operation. You will participate in quality, compliance and safety programs for the daily manufacturing operations of biologic products to support gene therapy clinical trial and product development. In addition, you will participate in the implementation of process improvements/scale-up. Shift/weekend work and lifting 40 lbs. unassisted is required at times.

Major Responsibilities: Design and execute production studies leveraging 4DMT’s vector platform processes. Collaborate with process & analytical teams to screen and evaluate drug candidates across a range of indications. Draft and update batch records, electronic lab notebooks (ELN), standard operating procedures and technical reports. Responsible for documentation that is IND-supporting and will be communicated to relevant internal/external stakeholder &/or regulatory parties. Document, consolidate, interpret and communicate scientific findings with internal/external teams. Contribute to a culture that embraces continuous learning, improvement and innovation. Can work with others to expand their technical skill base and deepen their gene therapy expertise. etc.

We have an exciting opportunity for a Lab Tech I within our Abbott Rapid Diagnostics business located at San Diego, CA.  In this role, you will be responsible for a variety of manufacturing support functions involving the operation of lab equipment and conduct of procedures/tasks according to established QSR’s ISO, ISO 13485, CMDR, and other pertaining regulations under the direction of senior staff.

We are seeking an experienced, high caliber Operator I. This position is responsible for the production of high quality medical devices within a manufacturing cell.

The Drug Product Development team at the AbbVie Bioresearch Center in Worcester, MA is responsible for designing and developing formulations that enable delivery of AbbVie’s candidate molecules in a dosage form suitable for preclinical or clinical studies. We are seeking a highly motivated, collaborative scientist with a proven track record in physicochemical characterization of small molecule candidates and application of drug delivery approaches in preclinical development. etc.

Based in our Burlingame Office, this manufacturing position is a great opportunity to transition into the medical device Industry! This role will be responsible for carrying out GMP manufacturing of IVD IHC primary antibodies according to the requirements of SOP’s, batch production records, and approved protocols. etc.

The position is primarily responsible for the screening and characterization of monoclonal antibodies. The successful candidate will play a hands-on role in the company’s use of a wide variety of analytical assays such as ELISA, flow cytometry, Octet, and HTRF. He or she will partner closely with other team members within the group, assisting with every step of antibody development. The candidate will make observations, analyze data, and interpret results with full supervision.

We are currently hiring for a Software Engineer who has experience in digital signal processing and algorithm development. The candidate is responsible for designing, simulating, and implementing performance enhancing signal processing algorithms used in ABIOMED’s family of products. We are looking for a motivated and energetic self-starter, has a ‘make it happen’ attitude, and can thrive in a fast-paced, cutting edge environment. etc.

The Research Associate I, under direction of the Molecular Sciences team, will support innovative experimental research that advances AbSci’s proprietary E. coli expression platform. Primary responsibilities include providing core support to ongoing DNA construction, strain engineering, and small-scale protein expression activities. Daily activities will include management of the Molecular Sciences laboratory consumables and sample libraries, preparation of common research reagents, and providing assistance to ongoing experiments. The ideal candidate will demonstrate rapid mastery of assigned tasks and the capacity to take on additional technical responsibilities within an expanding team.

The Research Associate will work as part of a team in a lab environment to completeclient-driven projects. Primary responsibilities include: Perform sample analysis following established SOPs underRUO/GLP/GMP conditions. Assist in the development and validation of new assays. General laboratory tasks including buffer preparation, samplelogging and handing, shipping samples to or for clients, equipment maintenance,lab maintenance, and ordering supplies. Ensuring the accuracy and timeliness of all laboratory-relatedprocesses. etc.

Absorption Systems provides analytical support for gene and cell therapy products through every stage of development. Absorption Systems also provides non-clinical testing services to pharmaceutical and biotech companies to support research and development of drugs, biologics, and medical devices. Absorption Systems is seeking a candidate for either an Associate Scientist or Scientist position with drug transport and metabolism experience at the headquarter location in Exton, Pennsylvania. etc.

The Fill Technician will perform a variety of processing duties according to Batch Records (BRs) and Manufacturing Work Instructions (MWIs) in a cGMP environment for the Consumable Manufacturing Department including, but not limited to: Cleaning/recovery of classified area and work spaces, components preparation. Aseptic filling. Final Consumable Inspection. Labeling and packaging. Line clearance and Closeout responsibilities. etc.

We are seeking a highly organized, motivated individual with experience in media and buffer preparation, mammalian cell culture, and recombinant protein expression. You will contribute to the development of our next-generation biologic therapeutics by generating cell lines and analyzing recombinant proteins. You will work cross-functionally with the Molecular Biology, Protein Purification, and Process Development groups and will have the opportunity to gain experience in multiple aspects of drug development.

This position is responsible for providing world class customer service during the provision, return and servicing of medical equipment inclusive of responding to product inquiries or other identified customer needs. The daily responsibilities encompass the preparation of medical equipment for patient use to include sanitization and disinfection, quality control testing, preparation for use and transportation of the equipment to and from customer locations utilizing a company provided vehicle. In addition to preparation and provision of medical equipment, employees in this function are required to learn and operate within the company defined policies and procedures to maintain compliance with the regulated requirements for medical devices. Additional responsibilities include maintenance of a safe and clean service center working environment and company vehicles. etc.

The relevant experience required for a Clinical Education Specialist (CES) is a four year business degree or significant experience working with marketing activities, specifically digital marketing. The CES must possess a working knowledge of business principles, schedule management, organizational styles and marketing practices. The CES has the responsibility of supporting the Clinical Education Leader, President, and Director, R&D to move the company Up and Onward. The CES must assist to position Actuated Medical (AMI) as a company that Improves Patient Outcomes by developing Innovative Motion® Medical devices and providing clinical education to improve patient care.

The Sales Associate (SA) exceeds sales quota within an assigned territory by driving the market acceptance and adoption of Acumed products. S/he converts key surgeons to Acumed's products by utilizing a high level of technical and surgical knowledge. S/he focuses on developing relationships, listens to customer needs, and provides product solutions and services that exceed customer expectations. The SA provides technical advice to customers to ensure optimum use of our products to maximize surgeon satisfaction and patient outcomes. etc.

The Sales Associate (SA) exceeds sales quota within an assigned territory by driving the market acceptance and adoption of Acumed products. S/he converts key surgeons to Acumed's products by utilizing a high level of technical and surgical knowledge. S/he focuses on developing relationships, listens to customer needs, and provides product solutions and services that exceed customer expectations. The SA provides technical advice to customers to ensure optimum use of our products to maximize surgeon satisfaction and patient outcomes. etc.

The Sales Associate (SA) exceeds sales quota within an assigned territory by driving the market acceptance and adoption of Acumed products. S/he converts key surgeons to Acumed's products by utilizing a high level of technical and surgical knowledge. S/he focuses on developing relationships, listens to customer needs, and provides product solutions and services that exceed customer expectations. The SA provides technical advice to customers to ensure optimum use of our products to maximize surgeon satisfaction and patient outcomes. etc.

The Lab Operations QA/compliance Specialist supports activities in the Operations group at Adaptive Biotechnology’s Seattle laboratory. The primary function of this role is to support the QA/Compliance activities for the CAP/CLIA/NYS regulated laboratory, related to the services provided.

The QC Lab Support Associate I will Performs cGMP laboratory support activities including Sample Accessioning, Product Reserve management, Temperature Monitoring of storage chambers, Glassware Cleaning, Supply Inventory management, etc. May also assist with Stability Studies and other QC initiatives. Customer support functions for QC laboratories such as cleaning glassware and custodial services, monitoring temperature controlled chambers, shipping samples, sample preparation, administrative support.

The Document Assistant will Create, format, revise and proof read controlled documents such as Standard Operating Procedures (SOPs), Forms, Validations, etc. from departments including but not limited to Quality Assurance, Manufacturing, Facilities, and Quality Control. Perform general office duties such as photocopying, word processing, filing, scanning, physical inventory, ordering supplies.

Responsible for performing visual, mechanical and electrical inspections at subassembly and final assembly levels. DUTIES: 1. Perform visual and mechanical inspections at sub-assembly and final assembly levels, using engineering drawings/specifications and general quality control standards. 2. Records inspection data. 3. Review manufacturing documentation to ensure that all assembly, testing and inspection steps were performed in accordance to specifications. etc.

This is a Development Technician position in the Process Development Support group. Primary responsibility will be to support the process development team processes used for the manufacture of therapeutic recombinant proteins. The successful candidate will be responsible for lab support. Under general supervision, this person carries out routine to moderately complex lab operations. Responsibilities: Lab maintenance including cleaning, autoclaving parts, stocking laboratory supplies and performing maintenance on laboratory equipment. etc.

This is a Development Associate I position in the Upstream Process Development group. Primary responsibility will be to support mammalian cell culture processes used for the manufacture of therapeutic recombinant proteins. The successful candidate will be responsible for supporting shake flask and bioreactor experiments, sampling, inoculating, feeding & harvesting bioreactors. Under general supervision, this person carries out routine to moderately complex experiments or procedures. etc.

The Manufacturing Associate performs GMP manufacturing operations safely, reliably and in compliance with stated processes. PRINCIPAL RESPONSIBILTIES: Execute unit operations described in standard operating procedures and batch records. Perform bioprocess operations such as filtration, purification, cell culture or recovery. Perform review of GMP documentation. Clean, assemble/disassemble, sterilize and operate primary process equipment. etc.

We are seeking an experienced and highly motivated Manufacturing Support Technician to join our expanding Manufacturing team. PRINCIPAL RESPONSIBILITIES: Support product process unit operations described in standard operating procedures and batch records (100% of effort). Anticipates and minimizes deviations from support procedures. Stocking of supplies and gowning materials in GMP clean room areas. Weigh and dispensing of chemicals and processing materials. etc.

The Manufacturing Associate performs GMP manufacturing operations safely, reliably and in compliance with stated processes. Execute unit operations described in standard operating procedures and batch records. Perform bioprocess operations such as filtration, purification, cell culture or recovery. Clean, assemble/disassemble, sterilize and operate primary process equipment. etc.

This is a Development Associate I position in the Upstream Process Development group.  Primary responsibility will be to support mammalian cell culture processes used for the manufacture of therapeutic recombinant proteins.  The successful candidate will be responsible for supporting shake flask and bioreactor experiments, sampling, inoculating, feeding & harvesting bioreactors. Under general supervision, this person carries out routine to moderately complex experiments or procedures

This is a Development Technician position in the Process Development Support group.  Primary responsibility will be to support the process development team processes used for the manufacture of therapeutic recombinant proteins.  The successful candidate will be responsible for lab support. Under general supervision, this person carries out routine to moderately complex lab operations.

Essential Duties and Responsibilities: Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase gene therapy clinical programs. Increase compliance awareness and promote a culture of quality throughout the company, with a focus on laboratory and manufacturing operations. Collaborate with multiple functions to perform QA oversight and ensure quality-related activities are executed efficiently. Write, review and revise standard operating procedures. etc.

This individual is a Research Associate who will work with a team of research associates and scientist at AKESOgen. The Research Associate will work under the general direction of a Team Lead. This individual will perform extractions on a variety of sample types, genotyping on Affymetrix and/or Illumina platform equipment maintenance, solution and reagent preparation in addition to other tasks in laboratory. All duties are subject to change by managers during employment. etc.

We seek talented Analytical Scientists at various levels to join our expanding R&D team. You will be responsible for methods and process development for ANDA topical, suspensions and solutions, nasal sprays, inhalations, sterile injectable and ophthalmic products. You will develop and validate new analytical methods, conduct stability studies and perform sample testing to support regulatory submissions. ESSENTIAL FUNCTIONS: Independently develop analytical methods for drug substances, drug product, preservatives and degradation/impurities in the new drug products. etc.

The full-time, Development Engineer will have an opportunity to rotate through 3 areas of engineering within our Decatur, IL facility during their first year of employment – Maintenance, Projects and Technical.  

Revise and maintain controlled documents including, but not limited to: Master Batch Records, Standard Operating Procedures, Active Pharmaceutical Ingredient Specifications, Finished Drug Product Specifications, Forms, and Protocols.  Maintain and distribute Document Change Requests. Provide coverage for Front Desk.

Akoyais seeking an experienced Scientist to join our Quantitative Pathology Solutions –Phenoptics Services (QPS-PS), Image Analysis teamlocatedin Hopkinton, MA. Akoyaenables staining with up to eightantibodies utilizing our OPAL™ technology to provide unparalleled cellular/tissue imaging capabilities. QPS-PS is a dynamic team that develops multiplex OPAL™ panels for clients, then performs staining, imaging, and quantitative analysis of their samples. The QPS-PS Image Analysisteam focuses on imaging of stained slides and image analysis.

The Specialty Dermatology Pharmaceutical Sales Representative is accountable and responsible for her/his territory achieving or surpassing sales goals on a monthly basis. Takes ownership and demonstrates the ability to drive monthly sales results through superior selling skills - meeting and exceeding all performance goals. Proven ability to observe and identify market opportunities and challenges and subsequently develop, plan, implement, and follow through with action plans to positively influence opportunities and challenges.

Prepare, collect, and test plant purified water, manufacturing raw materials, product in-process, and finished product, and perform environmental monitoring. With limited supervision, learn and perform critical laboratory techniques and complete original work. Author problem reports and participate in investigations.  This description is inclusive of EM and testing duties: actual percentages of time spent on each duty may vary based on business needs.

The Materials Control Technician I is accountable for results in a fast-paced environment by following applicable SOPs and cGMPs to perform tasks for the receipt, storage, inventory and distribution of raw materials, intermediate or finished drugs or drug products and components. The Materials Control Technician I uses the electronic inventory system to track, document and control all inventory.

Assist engineering in identifying opportunities for change and realizing successful change in existing operations to attain quality, cost, and production requirements. Demonstrate knowledge of all equipment and processes in the areas of responsibility. Effectively and efficiently assist/lead efforts in product/process design. Coordinate detailed design efforts on process/equipment modifications and product changes.

Our Laboratory Technicians play a critical role in our manufacturing process by managing the room changeover process or the solution preparation process. Detailed, thorough cleaning, line clearance, and segregation of GMP and GMP Source production areas and associated equipment while wearing appropriate gowning. Diagnostic Kit Production: assisting in vial weighing, capping, and labeling of vials as well as associated paperwork

We are seeking a Metrology Technician! The Metrology Technician performs routine calibration, maintenance, troubleshooting, and repair of a variety of laboratory and manufacturing equipment in a cGMP environment. This individual will have the ability to perform a variety of routine and non-routine technical tasks and tests while having a great deal of initiative and judgement.

The role will primarily support sample preparation for proteomic analysis by state-of-the-art technologies including mass spectrometry and immunoassays. Studies performed will involve cutting edge science and require innovative concepts and strategies.

The Quality Assurance Associate will be responsible for performing functions including daily on the floor activities related to sterile manufacturing operations, on the floor batch record review, executed validation review, discrepancy identification, logbook review, AQL inspection of finished product, SAP transactions, room/utility walkthroughs, shutdown/incident form assessment/review and reconciliation, initiation of hold forms, training program support, and product shipping in a facility that manufactures sterile products in a GMP environment.

Responsible for analyzing and collecting past dues for specified accounts. Negotiates with customers without jeopardizing their relationship with Allergan to collect all past due invoices. Has knowledge of commonly used concepts, practices, and procedures within a particular field. Relies on experience and judgment to plan and accomplish tasks. Performs a variety of complicated tasks to minimize financial losses and obtain best possible DSO. Daily activities include establishing objectives, identifying areas of improvement internally and externally.

As a pharmaceutical Sales Representative, you will have the opportunity to regularly call on health care professionals (primary care physicians, clinics, hospitals and pharmacies) within a specific geographic area. Day-to-day responsibilities consist of supporting the promotional efforts behind Allergan products, which includes organizing, tracking and distributing FDA regulated sample products to health care professionals.

Provide excellence in statistical support and data analysis to drive the application of advanced and state-of-the-art statistical principles, tools and methodologies to improve process understanding, quality and compliance of the products, efficiency and capability of the processes and profitability of the organization. With general guidance provide direct technical support to Quality, Manufacturing, Development and Regulatory Affairs with hands-on analysis of process and product data. Applies appropriate statistical methods in order to improve and maintain optimal process control and product compliance.

Maintains regulatory databases, license approvals, user fees, certificates, and establishment registrations. Submits Unique Device Identification and labeling data to regulatory agencies using various third-party applications. Responsible for post market surveillance evaluation, trending, and reporting including updates to risk management (FMEA) process.Assists in developing, maintaining, assigning, and tracking company Standard Operating Procedures (SOPs) to ensure compliance with applicable global regulatory requirements.

Collaborates as a core team member on new product development teams. Determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities. Prepares regulatory submissions including 510(k) premarket notifications for US FDA. Prepares regulatory submissions including technical files/design dossiers for registration of products in European Union and interfaces as needed with Notified Bodies regarding significant changes to products. Evaluates design changes to products to determine impact to submissions and potential need for additional submissions.

The Clinical Data Coordinator is responsible for timely validation of clinical trial data. Review case report forms and clinical data sets for errors, discrepancies and protocol violations. Organize and maintain clinical study databases to support regulatory submissions. Communicate orally and/or written, in a timely and effective manner, with the appropriate internal or external individuals involved in the project

You will be working in a team that is handling one or two applications. You will be getting requirements from a QA manager and will be with the QA development team. You are responsible for the documentation, development and execution of basic manual test cases. You will also be working with the application development team for creating data sets for testing, debugging issues, and improving products. Your end users are mostly internal and need to be able to support them when necessary.

Research Associate I is responsible for assisting senior R&D staffs to design, develop, and validate clinical diagnostic assays spanning a wide range of Next-Generation sequencing and microarray technologies. Aid in the design and development of clinical diagnostic assays for use in a CLIA/CAP regulated setting. Perform research experiments, such as primer design and preparation, PCR, electrophoresis, gel imaging and analysis,

Monitor various line and equipment functions utilizing various computer interfaces and visual observation. Perform change over, teardown, and set-up tasks. Perform, monitor, and document wastewater and lift station properties. Complete documentation to ensure compliance with relevant standards (i.e. Medical Device Directive (MDD), QSR, CMDR, ISO 13485, JPAL, production and corporate standards)

The Automation Engineer is responsible for operating and maintaining Automation/Control systems that support all Ohio facilities. The incumbent has responsibility for indirectly supervising and directing internal resources as well as contract service providers The individual will be responsible for providing Subject Matter Expertise (SME) for various Automation/Control systems including PLC’s, HMI’s, SCADA, BAS/BMS, vision systems, servo and motor controls, and associated infrastructure.

Responsible for Technology Transfer and process scale up activities associated with parenteral drug products. Supports cross-functional Production, Engineering, Quality Assurance, and Validation departments to support the trouble shooting of manufacturing issues. Conduct the experiments under the supervision of Scientists for Tech Transfer, Process R&D/Scale up/Validation, and other activities needed for introduction of a new product into cGMP manufacturing site or to support process improvements of existing products. Execute laboratory experiments as per the protocols or under supervision to study material compatibility studies and/or cleaning validation activities

The R&D Document Coordinator I will author, edit, review, evaluate, and maintain GMP documentation (RM documents, FP documents, Analysis SOPs, Validation Protocols, Technical reports, etc. and all required revisions). The individual will co-ordinate with Document Control and Change Request reviewers from the documents initiation to the approval stage. Draft Raw Material, In-Process, and Finished Product documents. Provide editorial support and ensure quality of all document content; focus on clarity, accuracy and consistency, while maintaining adherence to proper formats, regulatory requirements and company procedures and guidelines.

The Associate will work with some of the brightest minds in the industry and get opportunities to solve some of the most challenging business problems. Amgen is using Enterprise Data Lake, cloud technology, and continuous deployment pipelines to produce science based insights to build new drug therapies for patients that address grievous illnesses.

In this role, you will work with some of the brightest minds in the industry, and you'll get an opportunity to solve some of the most challenging business problems. Amgen is using Enterprise Data Lake, cloud technology, and continuous deployment pipelines to produce science based insights to build new drug therapies for patients that address grievous illnesses. Applying specialized knowledge and understanding of principles, concepts and standards to moderately complex assignments

Amgen is seeking an integration engineer with experience and interest in building scalable integrations for enterprise applications. The integration engineer will have a real passion for developing and maintaining robust integration for On-Prem and Cloud applications to support critical business functions.

The Associate Manufacturing role will support the Drug Product Filling operations according to Standard Operating Procedures (SOPs). Will perform and monitor critical processes, execute routine protocols, and regularly draft and revise documents such as Manufacturing Procedures and SOPs. Perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams. Employee may also have the responsibility of owning NC/CAPA’s. May identify, recommend, and implement improvements related to routine functions in a Non-Standard Shift environment. Several positions available.

The QA Inspector I monitors and ensures all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. The QA Inspector I must monitor and ensure all phases of drug manufacturing are in compliance with established specifications; receive, inspect, release and control of labels and outserts, to ensure quality compliance before, during and after each packaging run.

The Quality Control Microbiologist is an integral part of the AMRI team and performs quality activities in support of product production and releases. The QC Microbiologist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending and reporting results.  

The Research Scientist is an integral part of the AMRI team, contributing to our success by the cultivation of microorganisms; the screening of biocatalysts and process conditions; and the production, isolation, purification, and analysis of the products of fermentation and/or biochemical transformation.

The technician's main duties are to ensure timeliness of testing, meeting client requirements. The technician must provide services that are compliant to the ALG-West Coast Quality Manual, client requirements and regulatory requirements as applicable such as ISO/IEC 17025:2017, USP, EU, GLP, GMP, FDA and ICH guidelines.

These responsibilities include order fulfilment, receiving, stocking of materials, replenishments, cycle counting, and returned goods within the inventory control area. Performs packing, labelling, checking and confirming in the Shipping area. Works with the parcel shipping and Bill of Lading systems. Operates an electric pallet jack, and forklift operation for loading/unloading trucks.

The QC Chemist position is responsible for independently performing testing in a pharmaceutical Quality Control laboratory. All work will be conducted in accordance with standard operating procedures and test methods. This includes performing testing on raw material, in-process and finished product samples. Execute compendia method validations, method transfers and validation support of new product development. Set up and confirm suitable operation of equipment and instrumentation. Collect data and generate/report results in accordance with governing test methods and SOPs.

Antech Diagnostics, the largest exclusively commercial veterinary diagnostic laboratory in the nation, is in search of a Float Laboratory Technician working out of our Lake Success, New York  laboratory and reporting directly to the Lab Manager. The Ideal Candidate will have prior experience as a Medical Technician that involved performing some clinical diagnostic testing & using testing equipment. In this integral role you will perform tests in all areas of the laboratory such as: Chemistry, Hematology, Coagulation, Urinalysis, Serology, Parasitology, Histology.

Operates injection molding machines according to specific schedules and procedures. Prepares mold inserts and reviews molded component integrity. Remove molded components from the mold once the machine has finished its cycle. When applicable test parts during machine cycle to predetermined specifications

As a Production Associate, you will be responsible for working within the framework of a team in a cleanroom or manufacturing environment, and performing the following activities: Perform all manufacturing operations in a cleanroom or non-cleanroom environment such as assembly, inspection, and machine operations. Comply with Applied Medical Quality Systems (QS) including SOPs, MIs, QIs and TMs. Perform manufacturing operations efficiently with or without tools and/or equipment

As a Project Engineer, you will be responsible for working within the framework of a team and performing the following activities: Update construction schedules based on team input. Receive, review, forward and track status of submittals. Initiate, prepare, review, track, and distribute RFIs. Assist in management of project permit process

The successful candidate will have extensive understanding of protein chemistry, protein characterization, and analytical techniques. The position will involve regular communication and collaboration with an interdisciplinary team within AMT and with outside contractors/consultants. Perform analytical method development for LC based assays such as SEC, IEX and reversed-phase HPLC, and other protein-based analysis (i.e. SDS-PAGE, western blot, A280)

We are looking for a part-time IT Support Technician to provide prompt IT support to the daily operations of various IT systems/devices. This technician is also responsible to set up new computers and systems for new hires and to decommission them when needed. This is a non-exempt role requiring an average of 20-25 hours a week.

A member of the R&D team responsible for the design and development of drug products for the targeted delivery of active pharmaceutical ingredients, including thin films for transmucosal delivery. Conducts laboratory activities and formulation work in support of product development, product characterization and process optimization. Prepares laboratory prototype samples for preclinical, in-vitro and stability evaluations

Associate level position for manufacturing medical devices in accordance with controlled procedures (SOPs) in compliance with Good Manufacturing Practice (GMP) regulations and current GMP (cGMP) guidelines. Manufactures solutions, labels and fills containers, labels and assembles kits. Compiles auditable electronic or paper records of manufacturing, maintains equipment logs and monitors supplies.

The successful candidate will bring hands-on experience performing in vivo experiments and with various animal handling techniques such as pharmaceutical agent dose administration (IV, PO, IP, IM) and blood/tissue collection. We seek candidates who are team oriented, diligent and meticulous, who display initiative and will be able to contribute intellectually to our science.

The successful candidate will have strong organizational skills and attention to detail, coupled with excellent practical laboratory skills, and aptitude and enthusiasm for automated laboratory assay techniques. Responsibilities include: Mammalian cell culture. Biological sample banking. Biology and tissue culture lab management, safety program support. Practical laboratory work, managing day to day tasks and ensuring timely delivery of high-quality results.

The successful applicant will be responsible for performing bioanalysis of in vitro and in vivo samples to support discovery and development programs. Develop, troubleshoot, and validate LC-MS/MS based bioanalytical methods. Analyze, summarize and report preclinical pharmacokinetic and toxicokinetic results. Conduct in vitro ADME experiments such as metabolic stability, plasma protein binding, CYP inhibition and induction assay as necessary

R&D Lab Tech performs general laboratory tasks under immediate supervision.  The work involves preparation of chemical reagents/mobile phase, assistance with chemical tracking/disposal, and assistance with sample retrieval, preparation and storage.  The position requires a high school diploma and some college coursework in chemistry or a related field is desired. The position also requires ability to use a personal computer, including familiarity with word processing, spreadsheet, email and database applications. 

The position requires the performance of variety of task including development and validation of analytical methods and qualitatively/quantitatively testing routine and non-routine client samples. This position requires knowledge of commonly used concepts, practices, procedures, and instrumentation (HPLC/IC) used in a chemistry laboratory. Research Scientist I work with direct supervision and reports to the lab supervisor. The Research Scientist I must be able to think and work independently, yet share ideas and work toward team goals.

Arrowhead is seeking an experienced Animal Technician to join our Laboratory Animal Resources staff. This is an excellent opportunity to utilize and advance the ideal candidate’s laboratory animal skills in a progressive, state-of-the-art and diverse facility.

Arrowhead Research seeks a full time Research Technician to join its drug targeting team at its research and development facility in Madison, WI. The candidate should be highly motivated, and enjoy working with a team of scientists in a fast-paced and highly cross-disciplinary environment. The individual will be primarily responsible for providing technical assistance in RNA and DNA isolations, cell culture, and general laboratory maintenance.

Support the development, implementation and improvements of manufacturing processes to produce cost effective quality products. Successful candidates for these positions will have a solid CNC Machining background, including experience with the setup, operation and troubleshooting of mills and/or Swiss lathes. Up to 5-axis machining experience is desired. The successful candidate for this position must be willing to attend initial training in the Naples, FL area if/as needed by Arthrex.

Work as part of a team where needed in the Receiving/Shipping/Labeling and Kitting departments. Works in conjunction with departmental SOP's, maintain accurate control of inventory in the finished goods and raw material warehouses. Receives/stores all materials for ACC's use and performs all necessary receiving transactions within Data Management System. Works in Shipping in fulfilment of customers' orders and generation of associated shipping documentation. Assists in labeling of product, packaging final product for sale and general departmental coverage during absenteeism.

Performs selected quality control testing activities, dependent upon assigned area, including the following: Responsible for conducting raw materials, in process, finished product and stability testing according to standard operating procedures. Completes appropriate documentation supporting testing procedures, including data capture forms, equipment logbooks, and inventory forms. Supports preparation of validation protocols, executes experiments, and provides data for validation reports.

Oversee the growth and inventory of tumor cell panels needed for primary and secondary screens. Provide assistance with carrying out binding screens against tumor cell panels. Share and present data to team members.

The Associate, Regulatory Affairs assists the regulatory representative to Project Teams for assigned projects or products and by providing regulatory tactical support and strategy under guidance from manager. Ensures that clinical trials meet regulatory requirements as designed. Prepares and ensures rapid and timely submission of new drugs and maintain applications to sustain approved status of marketed drug in conjunction with more senior members of the department.

In this role you will be responsible for assisting with the formulation development and testing efforts within our ocular drug development program. Located primarily at our labs in Burlington, MA and interfacing with other group members in our Waltham, MA offices, you will join a growing dynamic team of interdisciplinary scientists at a world leading company on the forefront of corneal crosslinking science.

ou get to participate in a variety of tasks including purification of biologics, keeping up-to-date GMP documentation, writing reports, ordering materials, and scheduling equipment services. You are conscientious about maintaining strict compliance with GMP manufacturing practices as you adhere to our standard operating procedures.

The Specialty Pharmaceutical Sales Representative will promote our growing portfolio of innovative, branded prescription pharmaceutical and dietary supplement products in Women’s Health, Hematology, Dermatology, and related specialties. The primary call point will be OB-GYN’s offices in their territory, calling on assigned healthcare providers, informing those providers on the features and benefits of our products to effectively grow our market share.

The Specialty Pharmaceutical Sales Representative will promote our growing portfolio of innovative, branded prescription pharmaceutical and dietary supplement products in Women’s Health, Hematology, Dermatology, and related specialties. The primary call point will be OB-GYN’s offices in their territory, calling on assigned healthcare providers, informing those providers on the features and benefits of our products to effectively grow our market share.

The Quality Compliance Engineer will provide support in the implementation, maintenance, and improvement of company-wide quality management systems, procedures and support processes. Proactively monitors the various elements of the quality system to help ensure compliance with quality system regulations and applicable national and international quality standards. Ensures processes and tools are established to ensure ongoing compliance with applicable requirements. Supports external audits by the FDA, AATB, the Notified Body, other regulatory bodies and third parties, and coordinates responses to applicable audit findings.

The Clinical Trials Assistant is responsible for supporting the organization to successfully develop and implement clinical trials across its product portfolio and development pipeline. The Clinical Trial Assistant provides a key support function to the clinical operations team. Under general guidance from Clinical Operations, you will support the Clinical team responsible for management of multiple clinical trials (all phases), and assure compliance with SOPs, FDA regulations, GCP and ICH guidelines.

The Research Sales Representative will be responsible for selling the company’s products and services by contacting prospective and established customers. The Research Sales Representative will follow up on leads and establish close customer contacts to promote the company’s products to select accounts as designated by Sales Management.

Quality Associate performs daily quality review of raw material documentation to ensure that materials being received are produced in accordance to Company methodology, procedures, and standards. Quality Associate completes Change Control, Supplier Quality, and Nonconformance and Corrective Action Preventive Action (CAPA) quality records related to Receiving & Inspection. Quality Associate is SME for Receiving & Inspection procedures and manages projects.

Over the course of two years, the TDP participant will complete four x 6-month rotations, with the option to combine two rotations into a single 12 month rotation.  The rotations will be based in Research and Development at Baxter’s Round Lake, IL, and Deerfield, IL, locations.  Participants can optionally have the opportunity to travel to or work from other Baxter Research and Development sites across the globe. 

The primary responsibilities of this role, Lab Technician II, are to: Under the direction of Lab Operations Managers and/or Lab Coordinators complete the testing processes ensuring process control, accurate data management, timely escalation of problem solving, and error correction; Ability to learn and apply scientific methods and non-routine techniques for analysis as directed by protocols and work instructions to deliver quality results - which may include preparation of reagents, media, controls and sample preparation

Responsible for carrying out routine and discovery experiments in partnership with scientists. Responsible for generating highest quality research data and performing validation experiments; Responsible for organizing and recording experiment notes/best practice documents in a timely fashion to secure the company’s IP and FTO; Manage best practice documents training of new members and help onboard new team members

This position reports to an engineer on the Dialysis Team.  An R&D technician helps with the generation of test protocols and reports, tests products and reports results, and helps to design and maintain test fixturing.  In addition, they may help with troubleshooting and test development. Assists in the execution of test protocols, methods and procedures. Sets up and operates test equipment and records measurements with limited supervision

The incumbent will join the Verification & Validation team as an Engineer I, providing support to a cross-functional team. The successful candidate will be responsible for supporting product verification activities and will support test method development activities, measurement system development & analyses, test fixture design. He/she will support the development of design verification strategies and DV execution required for sustaining existing and commercialization of various types of new medical device products used in drug delivery.

Performs any combination of tasks involved in the manufacture and assembly of medical devices. Perform a variety of duties to assemble all types and sizes of product, components, and sub-assemblies using a variety of standard and specialty assembly machines or hand operations. May be required to press, bond, solder, flare, strip, clamp, sand, weld, mount/takedown or inspect for appearance, gauging of parts by “no-go” or “go” gauges and set fixtures.

Performs routine set up, operation, preventative maintenance (PM) and reports troubleshooting of basic manufacturing equipment via manual or semi-automated means. Controls and adjusts machine settings. Inspects in-process parts to ensure consistent quality and removes defective product, packaging, and component material. Assists with root-cause analysis activities for process or product exceptions. Identifies and escalates any issues associated with the machine performance and/or product quality. 

This position must have a working knowledge of the design process and documentation for US, EU and OUS product launches. This position reviews the DHF for released products with regard to compliance to EU MDR, determine gaps, and develops mitigation plans and completes mitigation. This position is responsible for conducting engineering protocols and reports for product qualification and validations. This position should have working knowledge of New Product Development process, including design, development and implementation of new products, processes, test methods and equipment.

Beaufort is currently looking for a Clinical Trial Assistant to add to our growing Clinical Operations team! The Clinical Trial Assistant (CTA) is responsible for supporting the clinical project team in daily study activities and clinical trial conduct by providing administration and project tracking support.

The Laboratory Operations Specialist I, in the Bioanalytical division, is an entry-level Laboratory Operations Specialist who will work primarily in our lab and they will be accessioning clinical samples, following SOPs, documenting all work performed and will assist with QA tasks.

As a member of the BGIA Support team, the position will support next generation processes for genome sequencing. The successful candidate will be responsible for developing and executing standard work procedures on a wide range of molecular biology techniques related to Next Generation Sequencing.

This is a Part-Time position. Your responsibilities as a Laboratory Assistant 1 are to maintain the animal facility at Bio-Techne and perform general lab duties. Responsible for the welfare and immunization of all rodents that are used within R & D Systems. Follows company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance to the job. General lab duties including stocking and organizing supplies and materials and preparing reagents.

Responsible for performing QC testing for Value Assignment assays, QC release assays, stability, physical/visual inspections, any related QC function. Assists in the flow of product in the QC department. Assist in establishing QC specifications. Performs analysis and interpretation of test results, identifies deviations, and makes appropriate recommendations

Perform kitting, liquid / powder filling and labeling functions. Assist in the setup and running of automated liquid filling, labeling and packaging equipment. Assist in the setup and running of manual liquid and powder portable filling equipment. Comply with Good Manufacturing Practices (GMP’s) and Quality Systems Regulations (QSR). Inspect all materials being issued to and returning from shop orders. Accurately count and return all materials.

As a Equipment Technician 1 you will perform preventative maintenance and repair malfunctioning new and existing minor equipment. Respond and log supervisory alarms on TAC Monitoring System during business hours. Act as the secondary facility maintenance mechanic responsible 24/7 on call for TAC & Security System with department personnel. Assist with installing new and existing equipment, offices furniture and shelves.  Perform additional duties as assigned.

Responsible for developing controls, calibrators, working solutions, and intermediates according to approved standard operating procedures.  Responsible for developing quality products on schedule.  General knowledge and basic application of concepts, theories, terminology and practices that apply to research in a laboratory environment. 

The responsibilities of this position are to perform lab support duties and tasks for multiple departments that include: collecting and washing used labware, preparing the labware for the autoclave, running the autoclave, and harvesting and concentration of cell culture media. Perform additional duties as assigned. This position requires a Tuesday through Saturday schedule.

Responsible for performing QC testing for Value Assignment assays, QC release assays, stability, physical/visual inspections, any related QC function. Assists in the flow of product in the QC department. Coordinate, perform and maintain QC testing and scheduling for Stability program, Assist in establishing QC specifications, Assist in the validation testing of equipment and processes, etc.

Generates, analyzes, and manages accurate and timely client proposals by: Reading, analyzing, and collaboratively working with the functional team owners to understand client’s Request for Proposal (“RFP”) & protocol. Validating pricing model is within acceptable company gross margin standards, escalating to Business Lead if outside margins. Consulting on standard, variable, and value-add costing parameters based on RFP and protocol.

TheImagingOperationsCoordinator performs data processing for allstudies. Review,process,trackand monitor alldata received from clinicalsites. Verify upon login that data received istheexpected data based on project protocol and previouspatientidentifiers. Review data discrepancies and resolve or route to study team as necessary/. et.

Perform preclinical pharmacology studies in rodents. Tasks include drug administration via multiple routes (IV, IP, SC, PO etc), blood and tissue collection, and tumor volume measurement. Experience with small animal surgery is a plus. Communicate and coordinate with other scientists on project team to draft, finalize, and implement study protocols. Follow protocols and independently execute tasks. Collect and record data. Prepare summary of experimental procedures and results and present data in team meetings.

Laboratory Technicians must have the technical training and experience required to perform regulated clinical laboratory testing, including sample accessioning and processing using standard in-vitro laboratory techniques which include DNA and RNA extraction from whole blood, ddPCR (digital droplet PCR), Mass Spectrometry for proteomic testing and to operate a proprietary LIMS.

The Analytical Development Associate Scientist facilitates and assists in execution of systems to assure cGMP compliance for all relevant operations carried out within and for BioDuro, LLC.  Responsible for performing pharmaceutical formulation sample and finished product analysis testing and basic validation experiments using different analytical instruments (HPLC, Dissolution, and KF) and general laboratory duties.

The successful candidate will have hands-on experience with a variety of in vitro and in vivo models relevant for neurodegenerative diseases and the ability to utilize these models for target validation, mechanism of action studies and support for drug discovery projects as a member of our world class research team in the Alzheimer’s Disease and Dementia Research Unit. As Associate Scientist II, the expectation is that the incumbent is capable of planning and executing experiments in consultation with the supervisor including the analysis and interpretation of the experimental results to achieve agreed upon objectives.

The Manufacturing Associate performs and documents manufacturing operations in a cGMP environment that involves operation of process equipment, execution of validation protocols, creating/ revising cGMP documents and other assignments. The role will: Execute manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system. May coordinate or lead process steps as requested. Document/Record and Review cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Revises or creates documents as instructed. Key documentation includes batch records, SLRs, and equipment logbooks.

The Process Development Associate will be an integral member of a team that ensures the highest quality of our finalized antibody products. This position offers the opportunity to gain experience with different types of conjugation chemistries and different chromatography methods to purify conjugated antibodies and offers the opportunity to work in small scale to large scale product projects and to learn to utilize the (Enterprise Resource Planning) ERP database to track production schedules and deadlines and to enter production results

. This position offers a varied work load and will enable you to gain solid experience that will allow you to grow and increase your skill set within a fast-growing and stable biotech company. This position will also allow you to gain experience in all areas of tissue culture and cross training on a variety of other supporting tasks such as downstream processing, ELISA assays, qPCR, mycoplasma detection, and NOVA BioProfile 400 use and maintenance.

The CST Project Coordinator will handle internal project coordination for our custom solutions team and contribute BioLegend’s mission of providing legendary customer service. They will be accountable for their own project pipeline, from the initial scoping through to manufacturing and timely delivery to the customer.

The Clinical Trial Assistant (CTA) performs essential responsibilities for successful trial execution at BioMarin. The CTA assists with the coordination of activities associated with the start-up, management, and close-out of clinical studies under the direction the Clinical Operations team. This may include assisting with study matters that impact study timelines, quality and budget.

The Research Associate I/II, functions to manage, coordinate, and perform activities required for the testing of drug product or human and animal specimens associated with one or more research and pre-clinical studies. In this position the candidate will work closely with Scientists in the Research group focused on mass spectrometry-based assays. 

The Quality Control Analyst’s main job responsibility is to manage the Quality Control In-Process department documents to ensure their accuracy, quality and integrity. The candidate will organize, maintain, track and archive department documents and records while adhering to the BioMarin's document lifecycle procedures and in accordance with the records retention schedule. The QC Analyst may be required to develop new processes and improve upon the current system to allow retrieval of data records more effectively. Periodically, the QC analyst may be responsible for training employees on records management procedures and policies, which include documentation, retention, retrieval, destruction and disaster recovery.

Provide technical support to operations engineering and instrument manufacturing with responsibilities specific to printed circuit board assemblies (PCBAs), mechanical assemblies, assembly fixtures, and test equipment. Assist engineers in projects related to manufacturing and electronic test devices used in the production and functional qualification of In vitro diagnostic laboratory equipment. Support and sustain instrument manufacturing activities and facilitate efficient operations within the production environment, optimize existing processes and ensure established production processes are achieved.

Contributes, with technical and scientific expertise, to the design and development of differentiated, high quality products on time, within budget, and with a high degree of customer satisfaction.

As a part of our San Jose team, the successful applicant will work with other members of Consumables Production, as well as a multidisciplinary team of engineers and scientists, to support the assembly of WES cartridges for biotech products. Operate and maintain robotic and manufacturing equipment. Ability to use hand tools such as small wrenches, pliers, tweezers, etc. Perform in-process QC and record results.

Under the supervision of Biotium scientists, perform production and quality control testing of assay kit components following standardized protocols. Under the supervision of scientists, perform R&D assays to develop new fluorescence-based products. This individual will be responsible for production and QC of products, as well as play a role in the design,optimization and assessment of novel reagents for fluorescent detection technologies.

The Associate Sales Representative (ASR) plays a critical role in helping to improve people’s lives every day, interacting directly with healthcare providers and their patients to introduce our products. ASRs also educate patients on the proper use of our products and provide invaluable support to the entire sales team. Develop and execute regional business plans to achieve quotas for assigned products, which may include cold calling to develop new customers, qualifying and following up on leads and selling to new and/or existing accounts

Meet or exceed sales objectives set by the BioVision management. Learn and master BioVision's product offering and manufacturing capabilities. Establish long-term relationships with the customers and match BioVision's capabilities with customer needs. Identify key contacts and decision makers to maximize the benefits from customer visits. Develop a customer-specific account management approach, identifying new business and growth opportunities

To perform the duties associated with labeling, inspecting and packaging of Boehringer Ingelheim vaccines. Performs and executes with others, all daily scheduled activities associated with packaging vaccines. Label and inspect products accurately and efficiently, to meet quality guidelines. Complete documentation in an accurate, concurrent and timely manner

The QC Microbiologist I conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures.  Duties will include analysis of pharmaceutical products through compendial methods and client specific test protocols. Prepares and analyzes samples to determine microbiological quality through the following analyses: Microbial enumeration methods, absence of specified microorganisms, endotoxin, and water quality analysis (bioburden, TOC, Conductivity).

The Lab Technician will perform routine laboratory tasks and assist laboratory personnel according to FDA, cGMP and Boston Analytical’s Standard Operating Procedures. Cleans and maintains laboratory glassware, equipment, supplies and laboratory. Properly handles, stores and disposes of hazardous materials. Assists Chemists and other company personnel on an as needed basis.

The Quality Assurance Specialist supports the QA Lead and the company’s quality program by auditing chemists analytical data, routine work, protocols and reports. Auditing chemists’ routine project folders for conformance to company and customer requirements. Write, review and edit Standard Operating Procedures (SOP’s, Forms and Methods) and familiarity with internal SOPs. Alternate contact person for QA questions relating to laboratory operations and client correspondences.

The Design Assurance Engineer I is a quality engineer that directly supports medical device product development from concept through commercialization.  This position will work with high-performance cross-functional development team to establish and maintain the design control deliverables, risk management activities, and DHF compliance within Interventional Cardiology to ensure delivery of the highest quality product to the customer.  

This Technical Writer will work as a team member on product development or other technology projects to bring clarity and consistency to documents through accurate and concise writing and effective use of document format. In summary, this tech writer will write, revise, organize, plan, summarize, edit, and proofread technical engineering documents and maintain project records.

The Compliance Analyst for Global Compliance Training and Communications will be responsible for implementing and maintaining components of a comprehensive compliance training and communication program. Ideal candidates will have strong analytical, verbal and written communication and project management skills and understand risks related to regulations applicable to the medical device industry (e.g. the anti-kickback statute, Foreign Corrupt Practices Act, etc.).

In this role you will work closely with Patient Care and the Complaint Call Center areas to process all customer issues and identify complaints, as required by FDA, Canadian, European, and other International regulations related to medical device manufacturers. Maintain all complaint files in accordance to Boston Scientific policies.  The position will support post market and clinical studies.  Must be able to work well in a team environment, foster team building, proactively communicate project and task status, and operate with a high level of initiative.  Possess verbal and written communication skills to communicate effectively with various levels of management in both business and technical communities. 

Responsible for the support of clinical and commercial drug manufacturing in the new Viral Vector Manufacturing facility located at the Cambridge, MA campus. Scope includes designing, specifying, and supporting manufacturing equipment such as autoclaves, incubators and analytical equipment in our newly built viral vector manufacturing facility. Individual will be part of an experienced team of process and automation engineers working closely with groups such as manufacturing, quality assurance, quality control and validation.

he Process Sciences (PS) Associate’s primary responsibility is to support the process establishment, pilot, and process characterization for the manufacturing of viral vectors. This position requires close interaction with the PS colleagues, Manufacturing Science & Technology, Manufacturing, Process Development, and other departments.  This role will focus on defining and characterizing robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial viral vector therapeutics.

Responsible for cGMP manufacturing operations at the Brammer Lexington site Downstream Operations. Executing aseptic operations within Biosafety cabinet and cleanroom environment. Preparation of buffers to support downstream purification activities. Performing Chromatography, TFF, Viral Filtration, and Final Formulation steps. Performing various filter integrity tests throughout the process. Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.

The Associate Biological Technician performs semi-routine or diversified work that requires the ability to differentiate established principles and practices from unique occurrences which may necessitate adapting or modifying methods. May be required to breed and develop animal colonies, collect tissue samples and collect data for routine operations. Perform support duties that involve animal health maintenance, i.e. sentinel program, water and feed evaluation, sanitation sampling and testing, and other related tests, as required

This position will specifically support acquisition, processing, and analysis of human tumor tissue. The candidate will contribute to tumor tissue analysis, including drug response, phenotypic, histoloical, and genomic/transcriptomic analyses of these tissues. The candidate will be expected to effectively collaborate with colleagues in the oncology, translational medicine, biomarker and clinical groups. The successful candidate will demonstrate clear verbal and written communication skills.

Provides technical and engineering expertise to the Brooks Automation Manufacturing Engineering team in enhancing the design and implementation of our Robotics production area.  Candidate must be proficient and hands on in applications of LEAN principles such as DFT (Design Flow Technology), Value Stream mapping, and 5S, in addition to concepts in 6 Sigma statistical reviews of processes in an electro-mechanical environment.

The candidate will play a significant role in the implementation of in vitro studies to characterize and differentiate the biological consequences of our small molecule therapeutics to advance early drug discovery programs. Responsibilities include: Perform cell-based studies to support identification/validation/differentiation of small molecule mechanism of action. Routine implementation of a wide variety of laboratory techniques: mammalian cell culture, cell-based genetic engineering (lentiviral, CRISPR), flow cytometry, etc. Maintain written records of laboratory experiments, data, conclusions and communicate results in a clear/concise manner.

Warehouse Operations is responsible for performing/controlling a combination of manual or automated tasks necessary for the receipt, storage, and shipment of product. This may include functions of receiving, picking, packing, shipping, staging, transporting, storage, delivery, etc. Also responsible for the efficient flow of products from the point of product receipt from vendors to the shipment of products (via prescribed service parameters) to a variety of internal and external customers.

Warehouse Operations is responsible for performing/controlling a combination of manual or automated tasks necessary for the receipt, storage, and shipment of product. This may include functions of receiving, picking, packing, shipping, staging, transporting, storage, delivery, etc. Also responsible for the efficient flow of products from the point of product receipt from vendors to the shipment of products (via prescribed service parameters) to a variety of internal and external customers.

Research and Development Engineering is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices. Research and Development Engineering is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices.

The Assembly Technician I will be expected to perform basic functions to complete day-to-day production activity. The position requires a highly motivated, positive individual that can work both independently and in a “team” environment. Assembly Technician I level employees will be expected to perform all job duties in the areas they are assigned under basic supervision. They will stay on task and complete quality work with accurate documentation. He/she will be a valuable and trustworthy asset to their work area through quality work of trained processes. This individual must be dedicated to the success of CSI and its quest to continually improve its operations, as well as perform duties to manufacture CSI products, meeting FDA, OSHA, GMP/MDD and ISO compliance requirements.

The Clinical Laboratory Assistant (CLA) performs a variety of laboratory and administrative tasks to support the clinical laboratory staff in the CLIA-certified CareDx laboratory. A CLA performs laboratory duties under direct and constant supervision of a licensed CLS or the Clinical Laboratory Manager (CLM) and/or designee, who provides specific instruction regarding how tasks are to be completed and defines the steps to be employed.

A Customer Support Representative acts on behalf of Caris as the first tier of support for all client issues or needs. This position responds to internal and external client inquiries regarding logistics, testing, supplies, and other support needs. This position handles all incoming documentation into the department. Independent judgment is required to carry out assignments that have a significant impact on clients.

The successful candidates will be integral in discovering and developing the next generation of therapies for hematological diseases. The successful candidates will have experience executing and analyzing in vivo experiments in hematology, specifically the hematopoietic and immune system. Basic cell and molecular biology skills are desirable.

The individual should possess strong core competencies in cell biology, molecular biology, assay development. Responsibilities include; Cell culture and cell line development using retro- and lenti-virus, CRISPR and downstream analysis of autophagy and signaling. Perform western blotting, FACS and imaging analysis to analyze autophagy and specific target activity in primary cells and cell lines. Aid in conducting genome-wide CRISPR screens for novel target ID. Use mouse tissue to both aid in the development of novel biomarkers and analyze key targets by protein and gene expression.

The Assistant Scientist, Upstream Process Development will perform a variety of laboratory procedures to support Upstream Process Development. The position will perform daily work assignments accurately and in a timely and safe manner. This position will independently evaluate, select and apply standardized scientific and techniques; assignments have clear and specified objectives, and require the investigation of a limited number of variables. This position relies on limited experience and exercises judgment within defined procedures and practices in making minor adaptations and modifications.

Catalent has an entry level Associate, Biomanufacturing position available.  As an Associate, Biomanufacturing  you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position.  Work hours are Sunday to Wednesday (4/10).

This a great entry-level opportunity for a new grad looking to gain hands-on industry experience and learn a variety of lab techniques. The Analytical Chemist I will be expected to understand and execute basic analytical procedures in order to assess the quality of pharmaceutical API, intermediates, and final drug products under limited supervision. Duties may include the preparation of simple aqueous and organic buffered solutions, volumetric dilution of samples and standards using good laboratory techniques, clear and accurate record keeping in laboratory notebooks, use of analytical instrumentation to acquire raw data, calculation and reporting of final results. The Chemist I will begin to develop product-specific cleaning methods to support use of GMP manufacturing equipment. 

Catalent has an entry level Associate, cGMP Manufacturing position available. As an Associate, cGMP Manufacturing (Good Manufacturing Practices) you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document cGMP Biomanufacturing activities. Shift position is Wednesday to Saturday (4/10) from 7:00 a.m. to 5:00 p.m. CST. Operates cGMP Biomanufacturing equipment, including pH/conductivity, meters, mix tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH).

As an Associate, Biomanufacturing you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position offering enticing compensation incentives. Work hours are Wednesday to Saturday (4/10). Operates cGMP Biomanufacturing equipment, including pH/conductivity, meters, mix tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH). Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) revisions, deviation investigations and change control/protocol execution, by established due dates. As an Associate, Biomanufacturing you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position offering enticing compensation incentives. Work hours are Wednesday to Saturday (4/10). Operates cGMP Biomanufacturing equipment, including pH/conductivity, meters, mix tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH). Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) revisions, deviation investigations and change control/protocol execution, by established due dates. As an Associate, Biomanufacturing you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position offering enticing compensation incentives. Work hours are Wednesday to Saturday (4/10). Operates cGMP Biomanufacturing equipment, including pH/conductivity, meters, mix tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH). Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) revisions, deviation investigations and change control/protocol execution, by established due dates.

The Solutions Prep, Associate I will perform aseptic techniques within in a clean room environment. Execute and properly document cGMP Biomanufacturing activities. The Solutions Prep, Associate I will operate cGMP Biomanufacturing equipment, including pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and analytical equipment as applicable. The position is expected to follow detailed instructions and established procedures with frequent supervision. Shift position is Sunday - Wednesday (4/10) from 7:00 a.m. to 5:30 p.m. CST. The Solutions Prep, Associate I will perform aseptic techniques within in a clean room environment. Execute and properly document cGMP Biomanufacturing activities. The Solutions Prep, Associate I will operate cGMP Biomanufacturing equipment, including pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and analytical equipment as applicable. The position is expected to follow detailed instructions and established procedures with frequent supervision. Shift position is Sunday - Wednesday (4/10) from 7:00 a.m. to 5:30 p.m. CST. The Solutions Prep, Associate I will perform aseptic techniques within in a clean room environment. Execute and properly document cGMP Biomanufacturing activities. The Solutions Prep, Associate I will operate cGMP Biomanufacturing equipment, including pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and analytical equipment as applicable. The position is expected to follow detailed instructions and established procedures with frequent supervision. Shift position is Sunday - Wednesday (4/10) from 7:00 a.m. to 5:30 p.m. CST.

As an Associate, Biomanufacturing you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position. Work hours are Sunday to Wednesday (4/10). Responsibilities include: Operates cGMP Biomanufacturing equipment, including pH/conductivity, meters, mix tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and Biosafety Cabinets (BSC) or Laminar Flow Hoods (LFH). Supports Biomanufacturing staff with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA) revisions, deviation investigations and change control/protocol execution, by established due dates.

We are seeking a highly organized Product Marketing Coordinator who will be responsible for supporting product marketing lifecycle management related projects, including product line discontinuations, product conversion campaigns, market research and promotions. This is an exciting opportunity for someone with strong analytical skills looking to work in a fast-paced, collaborative team setting where they can experience multiple facets of Product Marketing.

The successful candidate will join the Animal Care Team at Celsius Therapeutics in Cambridge, MA to ensure extraordinary animal welfare, compliance, and prime upkeep of the Animal Care Facility. Monitor daily animal health and welfare while performing daily animal health observations. Perform animal husbandry duties to maintain quality and health of research animals, including: performing daily water bottle and cage checks; provide appropriate food, water, and enrichment; perform cage changing as required; record and treat animal health concerns per SOP and/or specified protocols.

The Oligonucleotide Production Associate will perform tasks associated with the production of oligonucleotides in a dynamic fast paced GMP manufacturing environment.  The associate will also be required to provide support by maintaining inventory and buffer preparation.

The Quality and Compliance Associate is a key member the company’s SOP Committee actively enforcing the company’s policies and procedures in alignment with the overall Quality Management System (QMS). Maintains and promotes company and regulatory quality standards. Conducts activities involving quality assurance and compliance with applicable requirements. Responds to compliance questionnaires

To assist in the development and licensure of viral, bacterial and/or recombinant vaccines as well as new label claims or product improvement research of the licensed vaccines. Propagate cell, virus, bacteria and recombinant organism stocks, perform the testing such as cell counting, titrations, ELISA and other biological and/or molecular assays. Participate in planning and executing from research to large production scale up projects

Immediate need for Validation Specialist with experience in the Pharmaceutical and Biotech industry generating and executing protocols for equipment and utilities. Good writing skills a must. Overtime and some travel may be required. Submit resume along with availability

Support in vivo oncology studies in mice as a member of the MDC Team. Receive, characterize and orthotopically or heterotopically surgically implant tissue samples. Conduct tumor volume measurements and sample collection for in vitro characterization.

Support in vivo oncology studies in mice as a member of the Vivarium Operations Team. Clean equipment, rooms and facility according to a schedule devised by senior personnel; including floor sweeping and washing, cage washing and sterilization, and waste removal. Provide animal care including feeding and watering with food and water consumption monitoring.

Reviews and complies with all policies pertaining to the animal care program. Cares for and maintains laboratory animals in accordance with USDA Animal Welfare Act and policies, the “Guide for the Care and Use of Laboratory Animals,” and other applicable regulations and policies. Works closely with the Veterinarian to perform daily health assessments of the large animals in the Surgical Services Program and maintain all records as needed and associated with this monitoring. Provides animal treatments as instructed by the Veterinarian. Performs technical functions required by research protocols, such as daily clinical observations, diagnostic testing, administering medications to post-operative animals and health examinations of sick animals, prior to reporting adverse findings to Veterinarian responsible for that area.

This position will be responsible for handling and processing samples, and performing accurate data collection and reporting. Basic methods will be used to perform laboratory tasks with minimal supervision in the performance of studies.

The Research Technician I will collect and record data with minimal supervision in the performance of studies. Responsible for handling and restraining animals, clinical observations, sample collection, monitoring food consumption, animal husbandry, and performing accurate data collection and reporting. Administer test substances by various basic methods.

The Research Technician I will collect and record data with minimal supervision in the performance of studies. Responsible for handling and restraining animals, clinical observations, sample collection, monitoring food consumption, animal husbandry, and performing accurate data collection and reporting. Administer test substances by various basic methods.

Review of documentation for conformance to established procedures and regulatory guidelines. Ensure that work conforms to appropriate regulatory requirements, including SOP’s, US FDA and US EPA Good Laboratory Practices (GLP) and US FDA current Good Manufacturing Practices (cGMP). Perform QA functions in support of cGMP manufacturing as necessary.

Perform multi-step organic synthesis in solution and/or solid support: Optimize conditions to achieve desired yield; perform and interpret data analysis such as LC/MS and NMR; perform purification steps such as extraction, recrystallization, silica gel column chromatography and LC/MS purification; perform cGMP synthesis of pharmaceutical ingredients; and perform process development and scale-up for kilogram quantities; and clearly record and communicate results and challenges to coworkers/supervisor.

The Clinical Research Coordinator (CRC) is primarily responsible for coordinating the operational aspects of ongoing clinical projects to ensure that the clients’ goals of time, cost, and quality are met. The CRC may serve as the primary contact with the client to ensure appropriate communications, project budget management, and meeting of timelines. The CRC may also serve as the project lead responsible for directing internal teams in the execution of the protocol and ensuring that all staff working on any given protocol have been properly delegated by the Principal Investigator and adequately trained on the protocol.

The primary purpose of the QC Analytical Chemist is to provide support to the Production and Formulations Departments by analyzing pharmaceutical and/or cleaning samples. Support will be provided by analyzing samples using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs, client procedures, and miscellaneous protocols. The QC Analytical Chemist is expected to understand basic internal procedures, and conduct analyses with some supervision after training is complete. In addition, support is provided by ensuring the essential job functions of this position are completed as part of the daily and/or weekly schedule.The primary purpose of the QC Analytical Chemist is to provide support to the Production and Formulations Departments by analyzing pharmaceutical and/or cleaning samples. Support will be provided by analyzing samples using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs, client procedures, and miscellaneous protocols. The QC Analytical Chemist is expected to understand basic internal procedures, and conduct analyses with some supervision after training is complete. In addition, support is provided by ensuring the essential job functions of this position are completed as part of the daily and/or weekly schedule.

Responsibilities include: Construction of gene libraries and expression vectors. Characterization of gene variants. Primer design. DNA isolation. DNA sequencing. Cloning of genes and genetic pathways. Work with project teams to provide support and assistance to all phases of directed evolution projects, contribute to team presentations and written reports.

Codiak is seeking a qualified associate scientist to join our growing Research organization and contribute to the development of the company’s innovative exosome engineering platform. Responsibilities include: Produce, purify, and characterize engineered exosomes from conditioned cell culture medium; Execute biochemical and cell-based assays to validate target and pathway engagement of therapeutic candidates; Express and purify recombinant proteins, including antibodies, enzymes, and fusion proteins, at the milligram scale to support assay development for ongoing projects;etc.

As a member of the engineering services team, the Electrical Engineer I will solve complex problems and participate in the specification, design, prototyping and testing of a diverse range of tooling, fixtures, design for manufacturability projects, and other customer product design needs. Under the direction of the Electrical Engineering Manager, the engineer in this role will be performing design tasks of a complex technical nature requiring investigation of new technologies, and applying engineering design principles and practices.

You will be primarily responsible for the support and education of end-users, caregivers, and clinicians with Coloplast products and services. Acquire and demonstrate all necessary subject matter expertise to provide responses regarding product application and problem resolution to clinicians and end-users. Accurately and thoroughly document each end-user program enrollment in Coloplast systems per standard department procedures. Responsible for data quality, including self-audit of work

As a Clinical Lab Assistant, you will be responsible for assisting in daily clinical operations, primarily involving the performance of a novel clinical test for understanding genetic risk for specific diseases while working in a high complexity CLIA-certified laboratory.

his position provides an opportunity to work with cutting-edge technologies and contribute to BGIA’s goal of improving human health by providing genomic information to understand, prevent, diagnose, and treat diseases and conditions. As a member of the BGIA Support team, the position will support next generation processes for genome sequencing. The successful candidate will be responsible for developing and executing standard work procedures on a wide range of molecular biology techniques related to Next Generation Sequencing

The successful candidate will be responsible for developing and executing standard work procedures on a wide range of molecular biology techniques related to Next Generation Sequencing. Execute on and assist in the development of process instructions that ensure accuracy, throughput, and quality. Operate and monitor laboratory automation and instrumentation. Communicate issues and failures as necessary to the appropriate parties. General lab duties, such as restocking supplies and maintaining inventory.

We are looking for a Receptionist/Administrative Assistant to join our team. This person would assist our Administrative team in overall office and administrative activities as well as be the first point of contact in our offices. Maintains security by following procedures; monitoring logbook; issuing badges. Maintains records by scanning documents, labeling inventory, filing packing slips, updating spreadsheets, processing online scientific journal article requests.

The Manufacturing Engineer I will be responsible for the selection, development, qualification, and scale-up of production processes and equipment across different manufacturing departments. Process objectives are the high quality, high volume production of patient-tailored implants and associated instruments.

This position is responsible for operation of Pre/Post machining from start to finish for hip stem and hip acetabular Cups. Responsibilities include: Printing DHR’s for production release of hip stem and acetabular cup . Programming of acetabular cup and hip stem . CNC operation of acetabular cup and hip stem . Comply with all company policies and procedures including safety regulations, personal protective equipment requirements, Standard Operating Procedures, Work Instructions and Good Manufacturing Procedures

We are seeking a self-driven and continuous improvement-focused Quality Engineer I to join our Utica, NY based Quality Engineering team. In this role, you will work cross-functionally to support production lines for a variety of medical devices. You will execute projects aligned with CONMED's Quality System, ISO 13485 standards, risk management, test methods, calibration and product line support. Your efforts in problem solving, innovation and cross-functional collaboration will directly contribute to taking the site's safety, quality, delivery and cost metrics to the next level.

The primary purpose of the Quality Engineer (Post Market) position at Cook Winston-Salem is complete and review post market quality engineering activities, including complaint investigations, risk assessment, post market feedback, and product quality issues. Responsibilities include: Perform complaint investigations, including technical assessment of returned products. Complete risk assessments using post market data. Assist with the investigation, risk assessment and resolution of product quality and quality system issues. Implement, support and maintain post-production quality activities.

The Application Engineer at Cook Medical configures, implements and documents applications that provide the technical solutions to meet specifications and business requirements defined by company objectives to promote effective, efficient, and compliant operations. Technical responsibility for all stages of solution configuration to ensure compliance with application standards, architectural standards, and achievement of documented requirements. Ensure the stability, integrity and efficient operation of the business/workflow rules that supports core integration functions.

Responsible for providing technical support for the day-today production activities in the manufacture of custom, plastic components used in the assemblies of various medical devices.  This is a hands-on position with visibility on the manufacturing floor and requires a high level of interaction with the production, product development, and quality teams.   The engineer is responsible for supporting product development activities, continuous improvement, complaint resolution, CAPA investigations and other quality initiatives. 

The Operations Procedures, Technical Writer is responsible for optimizing the process to generate Operations Procedures and acts as the primary resource for authorship of procedures used by the Operations department (e.g. master batch records, process manuals, training documentation, operating manuals, etc.). The Technical Writer is responsible for ensuring that these documents are delivered on time, in a compliant fashion and to the standards expected by the team that own, execute and use the documents.

The Clinical Trial Assistant provides support to the clinical operations to assist with execution and maintenance of clinical studies. Acts as a central support for the clinical team for designated project communications, correspondence, and associated documentation. Maintains, updates, and may establish various databases for clinical activity tracking. Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites.

As a Research Assistant (Study Technician) in our Madison, WI In-Life department, you will monitor the research animals’ health and welfare using your experience in animal observation and your experience working with sample collections. Collection, documentation, and management of pertinent data from animal observations, test material administration, and clinical sample collection. Maintaining the facilities in accordance with the Association for Assessment and Accreditation of Laboratory Animal Care (AALAC)

Provide an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position. This is an entry level position into Quality Assurance Operations. Developing responsibilities include assisting with investigating deviations, relevant to area of responsibility. Responsible for driving continuous improvement on production floor to ensure compliance to cGMPs. Real time review of batch records, including critical processing steps with production floor presence.

The incumbent will be a member of the QA-Engineering team at the Holly Springs Influenza Vaccine manufacturing facility, supporting QC/Bulk and/or Fill-Finish Operations. The QA-Engineering Specialist applies Seqirus quality principles related to equipment qualification, method validation, process validation, Cleaning validation, shipping validation and technology transfers. Utilizes integrated commissioning and qualification principles to ensure compliance of equipment and system qualification. Supports the development and maintenance of quality procedures and systems related to Quality Assurance oversight. Provides technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, and regulatory requirements.

The incumbent will be a shop floor employee in the manufacturing organization. The incumbent will provide (or be trained in) the technical skill-sets necessary to manufacture high quality biologicals safely in a compliant, efficient, and cost effective manner. Responsibilities include: Ability to learn basic processes and equipment and serves as a hands-on resource in Production. Cleaning, preparing, and sterilizing production equipment. Assembly, set-up, and disassembly of production equipment. Interfacing with process automation systems and electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP, LiveLink)

The Clinical Research Associate completes project activities associated with monitoring functions of phase I through phase IV clinical research studies while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP) and applicable local regulations; provides clinical and technical support for CRAs and administrative staff; and performs management of study site activities to ensure integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).

The Research Associate will work closely with colleagues in platform development, biology, and pharmacology. In addition, the Research Associate will be responsible for restocking lab supplies and maintaining lab equipment. Core responsibilities include: Conduct whole body perfusion and collect tissue for histological analysis. Micro dissect and process inner ear tissues. Perform immunohistochemistry staining protocols. etc.

This position will report to the Senior Scientist – Enzymology in the Lawrence, KS research facility. Key responsibilities include: Perform routine drug screening assays for kinase inhibitors. Quality control of high throughput screening equipment. Together with supervisor, responsible for validating new biochemical assays and troubleshooting when needed to establish reliable screening platforms. Track and record data into corporate database and notebooks. Generate reports and create presentations as required by the organization.

Responsibilities to include: Performing key assays to support drug discovery using biochemistry, cell biology and/or biophysics. Generating high-quality, reproducible data by leveraging liquid handling, laboratory robotics and advanced data analysis tools. Identifying and developing new assays as the project requires. Communicating experimental results to project teams.

Dicerna Pharmaceuticals is looking for a BS/MS scientist to help in its drug discovery efforts. This is a hands-on research position that requires strong expertise in molecular and cellular methodologies. Key responsibilities include: siRNA drug candidate screening, hit identification, and lead optimization. In vivo drug candidate testing (e.g. mouse dosing; sample analysis)

Utilizes a developing to full understanding of operational processes and procedures to perform an assortment of assembly activities of moderate scope on a mixture of products, components, assemblies or sub assemblies. Follows methods, and sequence of operations according to specifications, blue prints and bills of materials. Ensures quality and product conformance. Sets up assembly for production. Performs various tasks which may include but is not limited to: wiring, component installation, hand soldering, cable harnessing, welding, painting, milling, filling, sewing, templating and fitting on assembly units. Performs maintenance responsibilities as needed and keeps surrounding area clean, safe and organized. Develops and recommends new methods to improve processes. Follows and complies with Company policies, standards and practices.

The technologist assistant assists the technologist with patient care by transporting patients between the facility and scanner; sanitizing and cleaning patient care and staff areas; changing table linens; entering exam and patient information electronically or on paper; and answering the telephone. The technologist assistant demonstrates the knowledge and skills necessary to provide care appropriate to the age of the patients served. The individual demonstrates knowledge of the principles of growth and development over the life span. He/she is able to identify and categorize each patient’s age-specific grouping of needs, such as those for infant, pediatric, adolescent, adult or geriatric patients.

Under the direct supervision of the site physician, performs various professional and administrative duties related to nuclear medicine stress testing including but not limited to: patient preparation-including IV start and EKG lead placement interpretation, administration of exercise and pharmacological stress tests, and application of ACLS measures to patients when directed. Activities not performed at the physician site are supervised by the Area Supervisors and Business Directors.

Job duties include: Estimate, plan, and coordinate testing activities. Develop test plan, test cases, test scenarios based on Users Stories and product’s design description to meet business requirements and technical specifications. Perform ad hoc, functional, integration, and regression testing. Identify software defects and submit problem reports via bug-tracking system. Perform regression testing on fixed issues.

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Responsibilities include: Key Responsibilities: Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. etc.

Applies knowledge of technical principles and Edwards systems/procedures to tptimize manufacturing processes. Responsibilities include: Improve manufacturing processes using engineering methods for concinous process improvement. Develop basic experiements and tests to qualify and validate manfactruing process, etc.

Multiple positions. Position titles include but are not limited to Plant Engineer, Process Engineer, Project Engineer, Development Engineer, Automation and/or Control Engineer, and are available in manufacturing and development areas supporting: Bulk processing (Animal health products), facilities/utilities engineering, process development.

This position is responsible for the inspection and packaging of product. Will perform all aspects of Inspection and Packaging with the ability to assist in day to day operations. Execute and document procedural steps in compliance with cGMP standards. Perform 100% visual inspection of product and classify rejected materials utilizing approved categories within required timelines (Qualification). Package product in final packaging components while verifying that lot information, including lot number and expiration date, are accurate

The Manufacturing Associate II position reports to Manager Manufacturing at Emergent Manufacturing Operations Baltimore (EMOB). Prior experience in GMP manufacturing and operation of GMP process equipment are prerequisites. Operates manufacturing equipment such as: incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment

Perform analytical testing per cGMP in support of raw material, in-process, final product, stability. Typical hours are 2:00pm – 10:30pm, Monday through Friday. Hours may vary to meet business and training needs. Perform WFI sampling and testing as per current protocol, or validation protocols to support the WFI system. Perform various analytical testing procedures as per manufacturing/quality control batch records, stability protocols, raw material requests for testing, etc.

This is a laboratory testing position with the major responsibilities being daily routine EM and Micro testing, and laboratory maintenance/upkeep tasks. Additional responsibilities involve quality systems support which includes supporting laboratory investigations as appropriate. Works with facilities/metrology to conduct and document execution of work orders to ensure GMP compliant state of labs and equipment. Performs routine EM and Micro testing following written procedures and limited non-routine testing including validation studies with supervisory oversight.

Execute tasks per cGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing qualification block training program. Actively incorporate the Core Values set out by Emergent BioSolutions while performing day to day activities. Maintain state of facility environmental control including: preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing surfaces and equipment per Standard Operating Procedures. etc.

The Analyst I position will design and prepare all protocols and reports related to novel and diverse validation activities. The candidate will focus on Equipment, Utilities, and Software Validation. Responsibilities include: Write and execute validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, equipment, systems, etc. Write summary reports, following good documentation practices. Use Kaye Validator, DataTrace dataloggers, and/or Veriteq dataloggers to perform mapping studies. Analyze statistical data to verify acceptable criteria. etc.

The right candidate must be organized and calm under pressure. Excellent communication skills are essential for this role for external interactions. This position requires a professional demeanor and a high level of discretion in regards to handling of confidential company information. Must enjoy a “start-up” atmosphere and be flexible, show initiative, good judgment and be willing to take on additional tasks and responsibilities as needed to achieve goals and deliverables. Must have strong knowledge of Microsoft Office (Outlook, Excel, Word, PowerPoint)

The Manufacturing Associate I – Fermentation works in a hands-on capacity in the cGMP fermentation and production support areas to manufacture Collagenase Clostridium Histolyticum (CCH) bulk drug substance (BDS). This role is responsible for supporting necessary fermentation and production activities, including validation and development work as needed.

Responsible for all aspects of validation, sample analysis and data preparation in support of pre-clinical and clinical studies. Ensure all work is conducted in accordance to GLP/GCP regulations. Conduct validation and sample analysis as per study method, in life study plan and or analytical/validation plans and SOPs in accordance to GLP/GCP. Promptly prepare and submit results after analysis. Work as a team and as directed by Study Managers and Lab Managers. Provide status reports on projects and accountable for meeting agreed timelines and performance quality. etc.

Support Multi-Million Dollar Fiber Processing and De-inking Assets, working in a Team environment, handling raw materials and finished Tissue parent rolls as necessary. 

The team is looking for a highly motivated Associate Scientist that will be responsible for routine screening of compounds in various in vitro toxicology assays. Responsible for planning and conducting high and low throughput toxicology screens, processing data to a high quality of standards, and within specified time frames.

Responsibilities include: Monitor the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and all applicable regulatory requirements. Conduct visits to assess the qualification of potential investigative sites, initiate sites, instruct site personnel on the proper conduct of studies and use of Electronic Data Capture (EDC) system, review and ensure accuracy of data collected, and terminate studies

This Person will be responsible for participating in a wide variety of laboratory-based activities related to chemistry to advance our innovative MiDROPS platform as well as animal procedures

The Reagent Manufacturing Associate is a member of our Proteomics Reagent Operations team. The scientist will be accountable for QC testing of raw materials, in-process materials and finished goods for release. This individual will also be a subject matter expert in the development and testing of new QC procedures.

The Product Development Scientist will play an active role in developing high-quality Fluidigm reagents. Responsibilities include: write application, product or system validation test plans. Work with product managers and product applications group. Ensure all valudation tests are in concordance with customer and product requirements. etc.

Basic Duties and Responsibilities: Assisting in clinical medical physics coverage, as well as supporting the commissioning team's project

Responsible for providing technical support to operations in terms of equipment/system/process initial validation and equipment/system/process requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. Individual must also perform HEPA filter integrity/velocity testing and critical area (class 100) airflow pattern testing. The individual must have a comprehensive understanding of cGMPs and become certified to enter Controlled Areas of the plant (class 100, 10,000 and 100,000). The ability to write reports clearly, concisely and accurately; accurately record data and a basic understanding of statistical analysis is also required to perform these duties. Weekends and Off-shift hours are periodically required.

Responsibilities include: hand assembly manufactured components, complete required documentation for work performance, quality inspect work performed. etc.

Responsibilities include: Assist with all aspects of EHS, including applicable OSHA regulations, environmental record keeping, safety audits, and accident investigations. Ensure the Emergency Response Plan remains current with regulatory requirements and site needs, assist with the readiness of FDBT personnel and facilities to respond to emergencies. Conduct environmental and safety audits and inspections; assist EHS Management with reporting to Senior Leadership.

Perform routine molecular biology lab duties such as DNA and RNA extraction, gel electrophoresis, solution and buffer preparation, and etc. Perform and document all test procedures with accuracy, consistency and timeliness in accordance with laboratory SOPs and regulatory guidelines. Assist with the generation and updating of laboratory SOPs. Perform basic lab maintenance tasks such as ordering lab supplies, and keeping detailed lab records.

This position isresponsible for the evaluationof humanblood products for manual orautomated cell isolations, product manufacturer,andcell culture.Perform QC testing and create a certificateof analysis(COA)for products manufactured. Record isolation details on a processing worksheet usinggood documentation practices. Operate flow cytometer and basic lab equipment.

Applicants should have demonstrated team management skills as well as working knowledge of IATA sample shipment processes, CLIA-waivered laboratory processes, and ability to fully manage external vendors for our clinical trial testing needs. This position ensures the full reconciliation of all specimens submitted to outside client and vendors in a manner fully compliant to Good Clinical Practice under FDA guidelines. Responsibilities include: Completes all study procedures as per FDA regulations, GCP guidelines and protocol requirements, Assists with and performs laboratory procedures including sample check-in, preparation, centrifugation, storage and shipment, Assists with temperature monitoring and control of laboratory sample environments, etc.

Assist in conduct of clinical studies. Provides licensed nursing coverage for studies and performs procedures as allowed by training and delegation. Duties include: Assist in the conduct of clinical studies while providing licensed coverage. Performs all job responsibilities in accordance with standards of Good Clinical Practice (GCP), clinic standard operating procedures (SOP’s), and OSHA guidelines. Perform tasks such as EKG’s, vital signs, phlebotomy, insertion and maintenance of IV catheters. Communicates in a timely manner with physicians regarding patient safety concerns, adverse events, protocol deviations, and any study conduct issues.

Responsible for the creation and transfer of manufacturing processes from R&D to Manufacturing and continuous improvement of existing processes. Responsibilties include: Maintains the Pilot Plant laboratory under cGMP conditions. Produces development, pilot and production materials per written instructions. Stocks and maintains the laboratory supplies. Completes laboratory work and associated paperwork by assigned completion dates

Responsible for the manufacture of GMP oligonucleotides; the continuous improvement of these existing oligo processes; and the development/transfer of new oligo processes.  Provides oligo process support to Operations group through instrument/oligo process troubleshooting and completion of NCR investigations.  Responsible for research, development and production manufacturing activities associated with oligos. Independently produces notebook, dev, pilot and production materials per written directions.

The ideal candidate is one who understands complex electro-mechanical systems, and how they interact with software, manufacturing, service, and external vendors, to fulfill product requirements. This position would report to the Director of Research and Development. Designs and directs engineering personnel in fabrication of test control apparatus and equipment, and determines methods, procedures, and conditions for testing the engineered products and associated apparatus. Applied electrical engineering knowledge concerning the research, design and development of new products having state-of-the-art sophistication for X-ray generators, data acquisition, signal processing, power supplies, etc.

The Quality Control Analyst ensures all Quality Control (QC) activities at Hovione LLC are carried out in compliance with Corporate Operating Procedures (COP), Standard Operating Procedures (SOP), Internal Operating Procedures (IOP), and Federal Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Occupational Safety and Health Administration (OSHA), and Environmental Protection Agency (EPA) requirements. Responsibilities include: Perform analytical testing (i.e. raw materials, intermediates, API, stability, cleaning, method validation and cleaning) in a timely manner to meet deadlines; Execute qualification tests contained in protocols for equipment qualification; Perform instrument calibrations on Balances, High Pressure Liquid Chromatography (HPLC) and Gas Chromatography (GC); Carries out routine tasks, routine housekeeping related to the laboratory, and maintenance of analytical equipment.

The Process Engineer will ensure that the use of the best process engineering knowledge will be applied in scaling up chemical and spray drying projects to maximize customer satisfaction and Hovione’s interests and in compliance with all Federal, State, Local and internal policies. Main responsibilities include; Plan and design manufacturing processes based on chemical procedures to run safely and effectively in a pilot plant/kilo lab in accordance with the best known practices ensuring cGMP compliance. Contributes to the Process Hazard Analysis (PHA) of all processes under his/her responsibility and assures that all identified hazards are addressed prior to performing any activities within operations. Prepares Mass balance sheet, instructions for unit operations, production batch records, Bill of Materials and other GMP related documentation for all processes run in operations. etc.

Responsible for coordinating the shipment of diagnostic samples as per client specific requirements. Maintaining sample integrity at all times, ensuring correct procedures are followed and correct documentation accompanies the shipment of samples. Quality checking of shipments to ensure correct samples are included and documentation accompanies shipments. Shipment of samples to other ICL locations or referral laboratories per protocol specific requirements. Coordinate courier collections with Logistics to ensure shipments are sent as per protocol specific requirements

Independently performs inspections on parts, materials, and supplies received from vendors, perform in-process production inspections, and ensure products comply with quality standards prior to shipment. Issues acceptance or rejection tags based on outcome of inspections, checking with supervisor on more difficult determinations. Familiar with manufacturing environment, inspecting, testing, sampling, and sorting of products / goods being manufactured.

Research Associate plays a pivotal role in our R & D teamwork on novel projects involving drug-device combinations for treating chronic diseases with the potential to dramatically impact patient outcomes. Responsibilities include: Independently carry out technical aspects of research projects including formulation work, sample preparation, conducting experiments, recording and managing data, and communicating results to supervisors and research team. Conduct bioanalytical assays and analyze data for the quantification of analytes. Record and manage data from complex experiments including preliminary statistical analysis

The Clinical Specialist must provide the healthcare professional with the most current information pertaining to Indivior products and their approved indications in a manner which will ensure the appropriate use of these products and achieve the business potential of the territory. Responsibilities include: Invest the time and the effort to achieve the established goals for the territory such as sales, market share, doctor calls, appropriate program planning, etc. Plan and organize daily sales call activities to optimize the use of time and maximize the achievement of sales objectives.

Assists with preparation of autoimmune diagnostic Immunofluorescence Assay (IFA) slide, control and conjugate products in accordance with established procedures. Major duties include preparation activities for IFA controls and conjugates and the growth of cloned antigens in insect cells. Maintains detailed Device History Records, laboratory notebooks and/or any associated documentation for all manufacturing and evaluation activities in accordance with current Quality Systems Regulations (QSRs). Tests IFA slide products for acceptable titer and pattern reactivity according to written Manufacturing Documents. Assists with the maintenance and growth of insect cells and the harvesting of various cloned antigens from these cells according to established procedures.

As a member of the Technical Support Team, provides product and technical support to customers via phone and email on all Inova products. Responsible for assessing customers’ needs and delivering exceptional customer service to provide remote support, basic troubleshooting, and issue resolution for Inova customers. Responds to customer product inquires on a broad range of technical questions regarding instrument and assay performance, instrument capabilities, quality control, and other product concerns. Interpersonal skills and technical product knowledge, judgement and decision making expertise are critical to responding to daily customer-centric activities.

Participate in cross-functional project teams to implement creative solutions. Monitors performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues. Interfaces with Quality and R&D to integrate new products or processes. Responsible for identifying and correcting manufacturing process nonconformance's identified during prototype builds. Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.

The primary purpose of this position is to develop competency in and performance basic assembly and/or inspection operations at Integer. The incumbent is expected to follow written procedures to meet production and quality requirements. Sets up equipment needed for assembly/inspection as per Manufacturing Process Instructions (MPI's) and Quality Work Instructions (QWI's). Understands own tasks and how they relate to others on their team. Works under close Supervision where duties are clearly defined. Will follow Standard Work where applicable. Assembles component parts as per print. Utilizes both manual and automatic machine operation.

Position summary: Perform most of the tasks and procedures required to ensure the timely and efficient processing of jobs through the manufacturing area. Maintain and update production and material control systems as needed to ensure proper job and material tracking is maintained. Maintain work area and equipment in a clean, neat, and organized fashion. Complete off-schedule notifications.

We seek a Research Associate I, who will work with a dedicated group of scientists on the development and commercialization of biomedical technologies. Conduct laboratory research and support general R&D efforts for customer-based biomedical research. Projects may involve cell culture, virology, DNA preparation, and liquid-handling automation. Perform cell-based assays (Western blot, ELISA, immunofluorescence, flow cytometry)

We are currently seeking a QC associate to work in both laboratory and cleanroom environments under strict SOP’s for performing environmental monitoring and other lab testing. Responsibilities include; sampling using EM equipment, sample handling, testing, reporting results with accurate documentation, investigation of OOS’s, and determination of root cause as appropriate

Manufacturing Associate will be responsible for the manufacture of pre-clinical/clinical products. Responsibilities include: Operates the production processes according to the determined daily production planning. Performs defined production processes according to GMP and SOP procedures (e.g., set-up, machine handling, close down, reconciliation,line cleaning, line clearance, waste disposal, storage, etc.).

As part of the pipeline engineering team, you will be responsible for maintaining, improving, and adding to our catalog of production bioinformatics pipelines across an expanding set of modern assays. You will be responsible for scaling our pipelines as we work toward our goal of providing low-cost genetic answers to billions of people. You will work and learn among an extraordinary set of peers: bioinformaticians, molecular biologists, and software engineers. Your work will directly improve the quality of our product and positively impact each tested patient.

As part of our Assay Tools team, you will help ensure that we can grow the breadth and scale of genetic tests on our menu. You will apply your knowledge of computer science, statistics, and NGS to analyze, improve, and develop an expanding set of modern assays. You will work and learn among an extraordinary set of peers: bioinformaticians, molecular biologists, and software engineers. Your work will directly impact early development work focused on improving the quality and capability of our products.

The Project Coordinator provides support to the Project Manager and related team members by performing generic procedures and tasks associated with the day to day running of projects throughout the entire study lifecycle (e.g. startup, maintenance and close-out); Ensure work is conducted in line with standard operating procedures, policies and good practices. Oversee and manage the timely closure of queries and work with the internal applicable teams or functional areas where applicable (examples may include, the Global Delivery Network, Contact Center or being the point of contact for client personnel to assist with service queries, including related to investigator reports).

The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus.

The Quality Assurance department is devoted to assuring safe, reliable and effective products that exceed patient, physician and hospital/clinic expectations. The department plays a vital role in product and process quality supporting commercial production for all Iridex products including laser consoles, delivery devices and accessories. The Quality Engineer (QE) works with a team of dedicated individuals supporting new product development and manufacturing operations to assure quality of finished product and identify quality issues related to electrical, mechanical and software subsystems. The QE evaluates product quality issues, performs root cause analysis, identifies remedial actions and follows up to ensure all actions are completed satisfactorily prior to resolution and closure.

Responsibilities inlcude: Utilize chromatography data systems and informatics platforms to analyze and distribute analytical results. The successful candidate will have some experience in chromatography, electrophoresis, and analytical chemistry. Experience with high throughput analytical testing, statistical analysis and high-performance liquid chromatography is a plus. The ideal candidate has strong written and verbal communications skills and works well independently and in teams.

Duties include: Process submitted samples into forms ready for analysis, such as grinding solid samples to a homogeneous mixture. Perform routine laboratory chemical analyses and/or instrumental test procedures using standard methods of analysis, and then calculate and report the assay results. Prepare and maintain chemicals, chemical solutions, sample dilutions, and equipment as needed for the performance of analyses. Maintain accurate records and documentation and assure the reliability of measurement systems by using appropriate GLP.

This position is responsible for providing world class customer service during the provision, return and servicing of medical equipment inclusive of responding to product inquiries or other identified customer needs. The daily responsibilities encompass the preparation of medical equipment for patient use to include sanitization and disinfection, quality control testing, preparation for use and transportation of the equipment to and from customer locations utilizing a company provided vehicle.

The individual will support buffer/media production in process development and pilot scale clinical manufacturing for products within the Kiniksa pipeline. In addition, the individual will support upstream/downstream operations in the manufacturing and process development department. This individual will also periodically support other disciplines including shipping, receiving and purchasing. It is preferred, but not required, that the candidate have experience with disposable technologies and solution preparation. The candidate must be highly motivated, eager to learn, science driven, and results oriented in a team environment. 

Responsibilities include: Assist in the development of broad range of topical product pharmaceutical formulations including gels, creams, solutions and ointments. Develop pharmaceutical formulations utilizing Quality by Design (QbD) and risk assessment concepts. Contribute and support the analytical efforts and interpretation of data generated from experimental batches. Write technical documents to support regulatory submissions and technical transfers.

Executes the activities of QC Microbiology Laboratory by following approved microbiological and chemical test procedures and ensure their delivery in an accurate and timely manner following proper safety precautions. Also provide QC microbiology support to the Aseptic Manufacturing and validation process. Performs Microbiological Tests and studies by following the established procedures referenced in the official sources. Preparation of microbiological media and diluents by following laboratory procedures, etc.

Sample Management Associate provides support to Sample Coordinator and performs administrative tasks in the Sample Management Department. Follows SOPs, and fulfills laboratory requests with minimum direct supervision. Performs duties and training to acquire the skills required for sample and standard handling in support of the laboratory. Quality Control related taskslike receiving, documenting, distributing and reconciliation of all samples received in the laboratory.

Responsibilities include but are not limited to: Greet all employees, visitors and guests and ensure they have a great experience. Answer and route incoming calls. Clerical duties such as scanning, digital filing, and data entry and report generation. Operations, shipping and receiving responsibilities including QC packages coming and going to ensure clients receive the correct items according to our protocols.

Perform cleaning and disinfection services within controlled environment manufacturing areas (i.e. clean rooms) to ensure compliance with current Good Manufacturing Practices (cGMP) and US Food and Drug Administration (US FDA). Maintain the assigned area housekeeping (per cGMP compliance) such as: cleaning walls, floors, doors, drains, windows, and other general surface areas. Follow written standard operating procedures to fulfill cGMP requirements for cleaning and disinfection of controlled clean room environments. Properly document completion of facility cleaning/disinfection in the form as required per SOP. Maintain cleaning equipment in good working condition, maintain cleaning/disinfection inventory, and keep cleaning supplies and equipment storage areas in neat and safe order.

This role has a direct impact on Inventory Accuracy and Productivity. High volumes and fast paced physical activity throughout most of the day characterize this role. Responsibilities include: Completion of all assigned warehouse duties within designated productivity rates. Completing all Safety Audit

As a member of the Lentigen Technology team, you will have the opportunity to perform duties within the area of infectious disease research and development. This includes genetic manipulation of viral vectors, immune cells and working with live HIV-1 as it relates to HIV Immunotherapy.  Furthermore, you will be responsible for designing specific experiments relevant to HIV Immunotherapy and analyzing the data using appropriate statistical methods.

You will use Lentigen’s expertise in lentiviral vector technology to analyze the biology of immune effector cells, stem cells and immortalized cell lines modified by lentiviral transduction. Furthermore, the unique duties of this position will allow you to master state of the art research and development techniques in molecular biology, lentiviral technology, genomics and immunology to make valuable contributions in keeping Lentigen Technologies, Inc. at the cutting edge of biomedical research.

This is a QC chemist position where one is responsible to make check standards, routine instrument maintenance and operation of GC/MS, GC/FID, HPLC, and UHPLC/MS, validating manufactured products in a timely manner. Attention to detail, teamwork, the ability to thrive in a fast-paced work environment and organizational skills are necessary to excel in this position.

The Machine Operator I is responsible for the setup and operation of standard packaging machinery in the packaging department.  This includes working with and monitoring other packaging personnel to complete equipment set up and operation required by the department schedule. Machine Operators must comply with regulatory requirements, Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP), and Manufacturing Process Records (MPR). They will perform all processes as required to fill, label, print, tray seal, pouch, final package, and inspect any Lifecore product; document completed work during packaging of final product; continually practice proper precautions and procedures when working with equipment and handling chemicals; participate in the review of batch records, etc.

Successful candidates will have basic knowledge of biochemistry and molecular biology techniques, in particular experience with, protein expression andpurification and cloning. Knowledge of the ubiquitin proteasome pathwayis desired.

Associate scientist needed in the area of pharmaceutical drug delivery research. Responsibilities include conducting laboratory experiments in support of formulation and process development. Knowledge of laboratory practices and demonstrated skills in analytical instrumental techniques (e.g. HPLC) are preferred. Excellent communication skills needed for preparing and following standard test methods and reporting experimental results.

We are looking for only the most driven Electrical Engineers with solid engineering fundamentals. Responsibilities include: Circuit simulation/modeling, Bench data collection, Scripting & overall test automation, Chipset evaluations (e.g Bluetooth, MCUs, accelerometers…), PCB design & layout, etc.

The Manufacturing Associate Level I (Night-Shift) is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.

The Lab Technician in the Blend Test Services Department is responsible for all facets of testing from the set-up and take-down to reporting of results. The majority of the workday is spent in a laboratory setting working with new and used oils, solvents, chemicals and equipment utilized to complete testing. This person is responsible for ensuring safety, quality, and timely delivery of test results while using good housekeeping practices during daily operations. Conduct quality tests following work instructions and ISO 9001 and ISO 17025 procedures. Ensure that all test protocols are in compliance with recognized industry or internal LZ test standards. Update work instructions and procedures as necessary. Plot reference data on control charts. Understand control charting and when to investigate potential issues. Must be able to identify, troubleshoot, and work closely with chemists and business partners to resolve issues or problems. Appropriately elevate the situation to chemist, manager and/or business partner when necessary.

The Reagent QC Associate assists with duties that span a broad range of activities within the quality control operations at Luminex. The selected candidate will be primarily responsible for Quality Control testing with the primary focus on raw material inspection, and in-process and final product testing. Responsibilities include: Performing assays for release of raw materials and products, and method validations . Complete appropriate documentation and data entry as required by procedures and tests performed. Reviewing and improving SOPs

The Manufacturing Assembly Associate Level 1 will be responsible for : The assembly, integration of mechanical, fluidic, electronic, optical and electro-mechanical systems. System integration testing and troubleshooting for all products in of support quality manufacturing production as a typical day to day requirement. Product knowledge, documentation transfer, training and inter-departmental communication also required. Performing assigned tasks that utilize their interdisciplinary skills to perform integration troubleshooting and assigned field service tasks. Performing set-up, calibration and operation of automated and semi-automated production equipment and fixtures, based on work area.

This is an entry level position. The Applications Engineer will be responsible for testing and analysis of customer samples for feasibility and performance of our terahertz equipment. With increasing familiarity and experience with our product line the Applications Engineer may assist with customer training, field trials of the developed applications, and the installation and/or minor servicing of gauging solutions at the customer’s facility. The Application Engineer will provide remote hardware/software support to customers located within the United States. Remote and onsite services/support will include install, repair and troubleshooting of terahertz gauging software and equipment found within an industrial environment.

The Quality Tech II analyzes process samples as received and performs non-routine analysis as requested. She/he will analyze finished goods and raw materials by chemical, physical, and instrumental means to ensure quality as needed. This position will be on a rotating schedule. Performs specified analysis on all process controls samples and reports in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques. Performs specified analysis on all finished goods using approved written procedures and proper laboratory techniques as needed.

Blend defined quantities of designated raw materials (per specific manufacturing instructions) into final dosage blend stage. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Blending Technician is expected to fully participate in both departmental projects and any quality working teams that may be applicable. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. etc.

MasterControl is looking for a creative and energetic test engineer to join our Digital Experience Team. This new team member will use innovative testing tools and methods to help make the MasterControl web experience a best-in-class experience. We are looking for a passionate, self-starter with a knack for uncovering issues and a willingness to switch context and change direction based on business needs. We are a small team that does big things. etc.

Perform routine calibration and preventive maintenance of Masy and customer equipment. Calibration may include temperature, relative humidity, CO2, voltage, pressure, time, rotation, etc. following documented procedures using precision standards. Calibrations will be performed in-house and at customer sites. Create, modify and execute calibration procedures and calibration certificates. Perform testing to support the quality management system and report, troubleshoot and make recommendations about quality issues relating to calibration. etc.

Responsibilities for this entry level position involve preparation, installation, and support for monitoring systems for both external customers and internal system usage. Duties/responsibilities: Travel to project sites to assist with start-up, integration, and validation services. Resolve customer issues or difficulties in a manner that is consistent with the company mission, values and financial objectives. Prepare monitoring system equipment. etc.

Duties Include: Operation of pharmaceutical manufacturing equipment including automated aseptic fill lines, washers, ovens, and autoclaves. Responsible for set-up, adjustments, sanitization, minor maintenance, and operation of all machinery in the sterile filling area. Experience in using aseptic technique to conduct aseptic filtration and filling of finished product. etc.

Duties include: Operation of pharmaceutical manufacturing equipment including automated aseptic fill lines, washers, ovens, and autoclaves. Responsible for set-up, adjustments, sanitization, minor maintenance, and operation of all machinery in the sterile filling area. Experience in using aseptic technique to conduct aseptic filtration and filling of finished product. etc.

Looking for an ECG interpreter, for our San Francisco, CA office, who is excited about having the front line responsibility of triaging the patients who have our life-saving products prescribed to them. Responsibilities include: Receiving ambulatory ECG data from phone and web transmissions. Making the correct arrhythmia call, not just knowing where to place the electrodes. Using proprietary software to efficiently compose arrhythmia reports for physicians, etc

Looking for an ECG interpreter, for our Burtonsville, Maryland office, who is excited about having the front line responsibility of triaging the patients who have our life-saving products prescribed to them. Responsibilities include: Receiving ambulatory ECG data from phone and web transmissions. Making the correct arrhythmia call, not just knowing where to place the electrodes. Using proprietary software to efficiently compose arrhythmia reports for physician. etc.

This Warehouse Worker position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your warehouse expertise and can develop and grow your career even further, then this is the opportunity for you.

This position has the authority and responsibility to be the primary integration point linking Strategic Sourcing with Research & Development and New Product Introduction (NPI) project teams. Technical Sourcing will lead the identification of Suppliers and reduction of overall supply risk and drive the adoption of capable technologies & sources in product development resulting in predictable supply & competitiveness through full product launch. Provides technical engineering expertise and leadership to the Supply Management organization and suppliers, serving as the technical liaison between Medtronic design requirements and suppliers' technical capability to assure that robust margins are achieved and maintained.

Responsibilities may include the following: Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

Medtronic is currently seeking a Hardware Design Assurance Engineer I. Daily responsibilities include: Participate in design trade-off studies. Risk assessment. Work closely with Development Engineering to assure appropriate requirement definitions are established. Work with development engineering and manufacturing engineering to translate design requirements to manufacturing requirements. Actively participate in the product development cycle to ensure quality issues are addressed and resolved prior to release. Assist in the development and implementation of methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Establish incoming inspection requirements and revise as necessary.

The Downstream Process Development and Engineering group within Biologics PR&D in Kenilworth, NJ to support process development for diverse therapeutic protein candidates in the Merck Research Labs pipeline. The individual will be responsible for the development of clinical and manufacturing processes for new protein candidates, focusing on both early and late stage programs with work spanning from initial process development for First in Human trials to process characterization for commercial manufacturing. In addition, the scientist will be responsible for supporting their development work with in-process analytics.

This position supports expansion of manufacturing operations in our GARDASIL® vaccine fermentation and purification production areas. The successful candidate will be a key member of a cross functional project team tasked with rapidly increasing manufacturing capacity through capital and smaller-scale improvement projects. The position will transition to supporting operations through production ramp up and into steady state manufacturing.  

The In Vitro Pharmacology department is seeking a highly motivated and technically skilled in-vitro scientist to join the Cellular Pharmacology group in Boston. The primary responsibilities will include implementation of various in vitro cellular assays, and execution of high throughput compound and biologics screens in support of internal drug discovery programs. The candidate is expected to work both independently and collaboratively with colleagues in the Pharmacology department and across other groups. 

Manufacture or evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department. Manufacture or evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department. Ensure quality throughout the process. Assure you are adequately trained to perform tasks/assignments. Perform routine assays, processes and/or unit operations. Contribute to support functions of the lab (e.g., maintain equipment, prepare reagents, restock lab supplies, waste disposal).

Perform all routine and relevant laboratory techniques in compliance with BioReliance regulatory standards.  Maintain and operate all laboratory equipment with some troubleshooting, as required.  Perform various cell culture operations for biosafety testing.  Maintains thorough records in addition to peer review of batch records.  Responsible for generating deviations as required and participating in resolving investigations with support of other team members.  Maintains a standard up keep of the facility through daily cleaning.  Actively performs equipment and general housekeeping daily checks and notify relevant personnel of any issues.  Initiates and completes projects independently, including troubleshooting during routine laboratory activities.

The purpose of this position is to Initiate and expedite the transfer of inventory from and to related parties. Ensure that all materials, equipment and tools are available for production and maintenance of site processes. Solicit price and delivery information from vendors, enters into computer files and communicates to appropriate departments. Coordinate with other departments the procurement of tools, materials and equipment.

The Manufacturing Technician I position will work in a cleanroom environment and adhere to cGMP batch records and SOPs to support the manufacturing of viral vector products. Employees will support projects in conjunction with other GMP Manufacturing personnel (Leads, Supervisors, Managers). Employees are expected to prepare suites for manufacturing, to document deviations, and to operate in a safe and compliant manner.

Mérieux NutriSciences is dedicated to improving food safety and quality though nutritional research, scientific excellence and innovation at every step of the food supply chain. Our team of scientists and technicians is committed to providing our clients with accurate results, delivered on time, with uncompromising ethics, honesty, personal integrity and confidentiality. NO PREVIOUS LABORATORY EXPERIENCE REQUIRED. etc.

Mérieux NutriSciences is dedicated to improving food safety and quality though nutritional research, scientific excellence and innovation at every step of the food supply chain. Our team of scientists and technicians is committed to providing our clients with accurate results, delivered on time, with uncompromising ethics, honesty, personal integrity and confidentiality. NO PREVIOUS LABORATORY EXPERIENCE REQUIRED. etc.

The incumbent is responsible for performing chemical analysis on food sample. The incumbent analyzes the concentration of certain components in food sample. The incumbent must accurately prepare and process the sample to obtain the needed results. etc.

We are currently seeking a Lab Assistant to provide assistance to our technicians and scientists. Responsibilities include: Carry out a number of procedures including preparing samples for analysis, sterilizing equipment, and general cleaning duties. Maintain working order of equipment and supplies necessary to perform analysis of food samples. Work closely with other team members and with the support of a department supervisor

Work as a member of a team to receive and log in client samples to prepare them for analysis. Review samples and documentation to assign identification numbers and enter data into our tracking system. Prepare packages for shipping and pick up by vendors. Contact clients when necessary to confirm information about test codes and sample contents. Achieve accurate, timely and consistent results to ensure samples are processed correctly

The incumbent is responsible for performing chemical analysis on food/pharmaceutical samples. The incumbent analyzes the concentration of certain components in food samples. The incumbent must accurately prepare and process the samples to obtain the needed results. This position reports to the Supervisor of Chemistry.

Work as a member of a team to receive and log in client samples to prepare them for analysis. Review samples and documentation to assign identification numbers and enter data into our tracking system. Prepare packages for shipping and pick up by vendors. Contact clients when necessary to confirm information about test codes and sample contents. Achieve accurate, timely and consistent results to ensure samples are processed correctly

The Engineer – Calibration and Reliability is mainly responsible for the integrity of the calibration process and to ensure all documentation and procedures are up-to-date and cover all regulatory requirements. Other responsibilities include the improvement of asset reliability through predictive maintenance, analysis of data collected, risk assessments or other reliability related techniques or processes.

Responsibilities include: Drive efforts to design, develop, validate, and continuously improve manufacturing processes. Develop & define production control methods to monitor process output and establish critical supplier metrics. Define and coordinate the design and development of manufacturing fixturing and test equipment. Coordinate with R&D to optimize the design for manufacturing and reliability.

The Regulatory Affairs Associate supports the regulatory activities for development projects including new products and life cycle management. This includes assisting with regulatory strategies and timelines as well as the development and implementation of submissions under the direction of a line manager. With support from Regulatory Affairs Manager, provide ongoing support to cross functional teams to provide regulatory strategies during product development.

The Commissioning & Support Engineer responsibility is two-fold: it includes both on-site, hands-on installation work and remote product support. The role of commissioning engineer involves frequent travel to customer sites to configure and commission the S250-series cyclotrons under installation. During remote weeks or between installs, this role functions more like product support, responsible for providing business critical technical support to other commissioning engineers, installers, field service engineers and customers to help ensure the highest operational status possible.

Essential Responsibilities: Manages incoming calls; respond to customer inquiries and/or direct calls accordingly. Receive and process orders received via phone, email, fax, website, Electronic Data Interchange (EDI) or other type of electronic Purchase Order system; calculates charges and process invoices. Review product availability and order status in the company ERP system (NetSuite). Open customer accounts in NetSuite. etc.

There are two openings. These positions are responsible for basic and routine tasks involved in the manufacture and assembly of the company's disposable test cartridges. Responsibilities: Follow written procedures for set-up, operation, and clean up of manufacturing equipments, final assembly, and packaging. Responsible for manual tasks including, pipette solution, pouch and box labeling, product inspection. Prepare materials used in the cartridge production process. etc.

There are two openings. These positions are responsible for basic and routine tasks involved in the manufacture and assembly of the company's disposable test cartridges. Follow written procedures for set-up, operation, and clean up of manufacturing equipments, final assembly, and packaging. Responsible for manual tasks including, pipette solution, pouch and box labeling, product inspection. Prepare materials used in the cartridge production process.

The Industrial Engineer I supports manufacturing of products for medical devices with work including operational systems development, process flow, operational needs and process efficiencies. Capacity analysis, Layout management, Systems support, Lean programs and Improvement projects are part of the daily activities. Job duties: Analyzes Capacity for production lines including time studies and line balancing.Develops Lean Manufacturing initiatives. Designs and develops operational systems processes for new products, product changes and enhancements. etc.

This position will lead efforts in the creation and development of new tooling, equipment and fixtures for R&D of medical device products and mfg. processes. Provides mechanical design concepts for automated and semi-automatic equipment and machinery aimed at improving mfg. productivity, capability, and quality. Supports process development activities of new equipment/fixtures/tooling by performing tests to prove that product subassemblies or finished products meet requirements. Works proactively on projects to carry design concepts through to production release and implementation. etc.

Under guidance and supervision, evaluates the chemical and physical properties of various organic and inorganic substances in order to investigate their applications to the medical device industry. Job duties: Primary work location is in the R&D chemistry laboratory. Secondary work location is in an office environment. Handles chemicals safely in accordance with approved processes and procedures. Performs laboratory tasks under direct supervision. etc.

In this role as a Sales Support Specialist you will be required to interact with internal and external customers from quotation generation through the Purchase Order processing phase. You will perform research using a variety of different databases including MilliporeSigma’s customer history database, service management database, contract management database, installation database and financial database. All of which store inquiries and information that MilliporeSigma has received from a customer and/or prospective customer. etc.

You will assist in evaluating safety practices with regard to team activities. Work both independently and in team environment. Manage sample inventory and department stock room. Troubleshoot interruptions to the normal process flow. Manage Quality and Retain Samples. Use lean and six sigma practices to optimize efficiency and eliminate waste from process. Adhere to process requirements in a continuously changing environment. etc.

The Customer Care Associate position involves working in a dynamic, fast paced, high energy call center, and rewarding team environment focused on delivering a better customer experience. You will be responsible for ensuring each transaction is processed within customer specifications for MilliporeSigma guidelines. As a Customer Care Associate, you must be eager to learn, be respectful, honest & humble, and embrace challenges. etc.

As a member of the Miltenyi Biotec Manufacturing team, you will have the exciting opportunity to participate in both the manufacture and process development of T-cells and multiple other cell therapy products within a GMP environment. The unique duties of this position will primarily consist of manufacturing primary human cells including activities that involve graft engineering for cellular therapies as well as supporting the development of scalable cell culture processes.

As a key member of the Miltenyi Biotec Accounting team, you will provide accounts payable and accounts receivable support including collecting and posting payments, assisting in debits and credits when needed, reconciling back-up documents to invoices, processing invoices through receipt and account verification, maintaining vendor and accounting files, and preparing and verifying bank deposits. Within this role, you will perform month end duties as required inclusive of GL review and journal entries, as well as providing general administrative support.

As a member of the Miltenyi Biotec Manufacturing team, you will have the exciting opportunity to participate in both the manufacture and process development of T-cells and multiple other cell therapy products within a GMP environment. The unique duties of this position will primarily consist of manufacturing primary human cells including activities that involve graft engineering for cellular therapies as well as supporting the development of scalable cell culture processes. Furthermore, you will be responsible for completing successful qualifications and ongoing support procedures for clean room operations and assisting in the development, writing, and review of SOPs, material specifications, standard manufacturing procedures, batch records and other GMP documentation.

As a key member of the Miltenyi Biotec Accounting team, you will provide accounts payable and accounts receivable support including collecting and posting payments, assisting in debits and credits when needed, reconciling back-up documents to invoices, processing invoices through receipt and account verification, maintaining vendor and accounting files, and preparing and verifying bank deposits. Within this role, you will perform month end duties as required inclusive of GL review and journal entries, as well as providing general administrative support.

To support this effort, we are seeking an Assembly and Test Technician to support the assembly of designed parts for the company’s core medical instruments. Within this role, you will be responsible for supporting all tasks and functions in producing interposer to chip assemblies, while inspecting incoming raw materials and maintaining inventory for all production parts. Overall, your keen ability to work with a multi-disciplinary team to lead and advance product development efforts will champion the continued success of Owl biomedical. etc.

As a member of Miltenyi Biotec’s Process Development team, you will have the exciting opportunity to support the development of new processes that will generate cellular therapeutic products. You will apply your GLP/GMP experience to perform and maintain cell cultures using aseptic techniques. Ideally, you will be able to order materials and maintain inventory with the goal in mind that every effort is aimed at developing and qualifying processes required for clinical cell and gene therapy products. etc.

As a member of the Lentigen Technology team, you will have the opportunity to perform duties within the area of development of new tests, including the development of a standard RCL test and in a second instance of an automatized RCL test. This includes the set-up of a standard test based on the use of C8166 cells, the characterization of the C8166 cells with respect to susceptibility and propagation of HIV over many cell passages, etc. A very issue related to this development is that the test has to comply with FDA requirements with at the end the transfer of the test to the QC department for routine use. etc.

One year general work experience or equivalent education. Ability to read and understand documents such as policy manuals, safety rules, operating and maintenance instructions, and procedure manuals; Ability to write routine reports and correspondence. Ability to effectively communicate information and respond to questions in person-to-person and small group situations with customers, clients, general public and other employees of the organization.

Operates machines, tends the tablet press, transfers products into containers, weighs, mixes materials, records documentation, and performs basic routine maintenance. Cleans equipment and rooms per SOP’s and monitors product quality. Verifies all batches by control number, part number, and quantity per specifications prior to running the lot. Starts machine and observes operation to ensure all machinery is operating properly. Stops machine and reports any malfunction to Tableting Lead. Assist in repairs. Performs set-up of tablet press, assigned preventive maintenance procedures, parts assembly, and cleaning hardware. Ensures each product is tableted according to specifications and standard operating procedures.

Reporting to the Principal Scientist, Process Development, the Senior Research Associate, Drug Product Process Sciences will work with in vitro bioanalytical systems to evaluate samples from in vivo studies. The successful candidate will be able to deliver reproducible and impactful results under ambitious timelines. Here’s What You’ll Do: Develop and characterize lipid nanoparticle (LNP) formulations for delivery of mRNA. etc.

This role will conduct research in the Process and Nucleic Acid Innovation group to develop and test novel nucleic acid constructs for use in various interdepartmental projects. A successful candidate will be inquisitive about the science and capable of problem solving by consulting literature and colleagues and designing experiments to test hypotheses. This role will utilize various techniques associated with RNA and DNA synthesis and purification, mammalian cell culture, and in vitro molecular biology. This assignment is expected to last 12 months.

The individual in this role will be responsible for production of DNA for all constructs using custom automation, Hamilton liquid Handlers, and chromatography solutions. The successful candidate must demonstrate the ability to quickly master new processes and the drive to be part of a dynamic, fast paced, and highly motivated team. They must have training in chromatography (UPLC/HPLC), liquid handlers, basic molecular biology techniques, and ability to work with custom automation. The anticipated time frame for this assignment is 6 months.

Molecular Templates is seeking a highly-motivated and skilled Research Associate to support research and development activities. The position will be primarily responsible for ETB protein production and analysis in accordance to established protocols, and performing general laboratory duties, including solution and media prep, labware sterilization, ordering supplies, and maintaining inventory and basic laboratory equipment. This position will require excellent technical, analytical, time management and organizational skills, along with adherence to written and verbal instructions and accurate and timely completion of documentation.

Molecular Templates is seeking a highly-motivated and skilled Research Associate to support downstream processing for Protein Sciences. This position will perform functions related to production of pre-clinical drug product and early-stage process development for protein sciences, including routine protein purification, equipment maintenance checks and calibration, data management, and assist in review and development methods and procedures to control or modify the process. This position will also aid in identifying continuous process improvement areas.

Molecular Templates is seeking an experienced and highly-motivated professional to support downstream processing for manufacturing activities. This position will perform functions related to production and manufacturing operations, including routine protein purification, equipment maintenance checks and calibration, data management, and assist in review and development methods and procedures to control or modify the manufacturing process. This position will also aid in identifying continuous process improvement areas.

The Fine Chemicals Specialist is responsible for developing and maintaining technical documentation for industrial and pharma customers. This role works closely with our global Fine Chemicals sales team to provide rapid response to customer requests for quote of new or existing products. Principal Duties & Responsibilities: Build required product documentation. Adjust documentation per customer requirements. Manage supplier qualification in alignment with MP Bio’s ISO procedures. etc.

Our laboratory located in Charlottesville, Virginia is looking for an entry level scientist to work in a microbial forensics laboratory. This staff member will become an integral part of our team receiving vital experience with research, sample preparation and analysis, while gaining a thorough understanding of relevant federal regulations, QA/Safety/SOPs, and instrumentation. Conducts technical tasks and laboratory experimentation under general supervision using established or project-specific protocols and SOPs. etc.

The Customer Service Representative I will provide professional, courteous, customer-centric service to the MSD customer base. This individual will directly interact with various customers and interface with multiple internal departments to facilitate the processing of quotes, orders and customer requests to allow for timely shipping of MSD products worldwide. etc.

A Research Associate is responsible for independently designing and executing experiments and analyzing the resulting data in support of reagent and assay development projects. This is a laboratory based position performing protein-based immunoassays on a routine basis with relatively high throughput (3-10 plates per day). The incumbent is expected to display a wide-degree of latitude, creativity and self-management. etc.

The Production Control Technician I is responsible for assisting in the control of production, documentation and inventory maintenance for multiple groups within Consumable Operations.  The position will help standardize and improve documentation, manufacturing procedures and processes to increase production efficiency and ensure best practices are followed.  The position will also help implement new products, projects and processes within Manufacturing Operations.  Some degree of professional latitude, creativity and self-management is expected.

Molecular Templates is seeking an experienced and highly-motivated professional to support upstream processing for manufacturing activities. This position will perform functions related to production and manufacturing operations, including routine microbial fermentation, equipment set-up and calibration tasks, media preparation, quality testing, process documentation, and assist in review and development methods and procedures to control or modify the manufacturing process. etc.

. The successful candidate will work both independently and collaboratively as part of the Cell Biology team. Perform a diverse range of cell-based assays to characterize lead candidates for various therapeutic mechanisms. Expand and differentiate human iPSCs towards the cardiovascular lineage. Execute a range of experiments using molecular biology and cell biology techniques including nucleic acid and protein isolation, qPCR, virus preparation, and metabolic assays. Manage aspects of housekeeping for the cell culture lab, including preparing reagents, helping with room maintenance, ordering and restocking.

The Process Tech III supports the clinical diagnostic lab by troubleshooting process failures, identifying and participating in continuous improvement projects in conjunction with staff and Technical Development, and participating on cross-functional teams to implement new processes into operations. This position will work with department management and quality team members to ensure that appropriate root cause is identified, corrective actions are implemented and proactive process improvements are identified. As directed by management, this role may also support Reagent Manufacturing processes, provided they are maintaining ongoing competency to perform those duties. etc.

The Training Specialist I, Prod-Ops Support administers the training program, ensuring that employee training needs are defined and met. This position works with Training Power Users and end users to ensure that job appropriate training is available and completed. Maintain training that meets all departmental needs and follows regulatory requirements for training and competency. Develop training materials for lab processes. Create a variety of training programs including e-training, computer-based, lecture, and other training formats.

The Laboratory Technician is responsible for specimen processing, testing and monitoring test performance. The technician must demonstrate competency, as defined in the department’s training program, prior to performing independent testing. This position will work with department management and quality team members to ensure that laboratory activities are defined, documented and completed to support inspection readiness and that compliance is maintained through procedures, training, documentation and continuous improvement projects.

Part time. Receives and directs calls, visitors, vendors, service personnel, and all paperwork in a confidential manner. Provides clerical and administrative assistance to leadership and teams. Maintains effective working relationships with co-workers, vendors and clients. Schedules appointments and travel arrangements, as requested. etc.

Principal Duties and Responsibilities. Independently conduct testing according to written instructions. May be requested to conduct more involved studies. May perform USP and EP monograph testing activities using wet chemical and analytical instrumentation. May conduct routine testing per NAMSA SOPs as well feasibility, protocol driven methodology, and/or method verifications on at least one of the following instrument types: HPLC, GC, or ICP, etc. Works with management to ensure large studies are completed on or before the due date. Prepare and maintain the reagents required for testing. etc.

May perform USP and EP monograph testing activities using wet chemical and analytical instrumentation. Can conduct routine testing per NAMSA SOPs for as well feasibility, one-off protocol driven methodology, and/or method verifications on at least one of the following instrument types: HPLC, GC, or ICP. Conduct the study according to written instructions. Prepare and maintain the reagents required for testing.

The Clinical Trial Assistant (CTA) is primarily responsible for supporting the clinical team. The CTA will manage coordination of activities and ensure timely flow of information to and from the team. S/he handles details of a highly confidential and critical nature, and must function efficiently and effectively in a fast-paced professional environment. S/he will have a proven ability to independently prioritize and manage multiple tasks and projects with competing priorities and deadlines, screen and prioritize communications and opportunities from external sources. etc.

The Automation Engineer I/II is responsible for maintaining existing Manufacturing systems as required. Additional duties include the development of new methods and implementation of new systems. The ideal candidate has knowledge of FDA and ISO requirements as they apply to manufacturing processes. Essential Duties: Maintain/Support Liquid Handling Equipment (Hamilton Star Workstations). Maintain/support customer/build in-house equipment. Support demand label printing system. etc.

The Manufacturing Research Associate I is responsible for supporting the production of reagents used in nCounter Analysis Systems. The role requires learning and performing both manual and automated production processes for the manufacture of raw, intermediate, and final reagents needed for the multiplexed detection and quantification of many different types of target molecules from biological samples. This individual learns to use professional concepts and apply company policies and procedures to resolve routine issues, in addition to acquiring the skills to use equipment, perform SOPs, use Document Control systems, ERP systems, etc.

Nanosyn is currently seeking a highly motivated candidate to join the analytical and compounds management team in Santa Clara, CA. The candidate will play a key role in the organization by being responsible for the planning and timely execution of characterization, purification, QC, data processing, etc. for Nanosyn’s chemistry/biology services. She/he will be responsible for consistently generating high quality data and meeting agreed upon timelines. Applicants must have at least 1 year of relevant experience, very strong organizational skills, the ability to work on multiple projects simultaneously, and be productive both independently and as part of a team. etc.

The Research Associate (Cell Culture Technician) will assist scientist/senior research associate for the culturing, plating, distribution, maintenance, and banking of cell culture lines. Important aspects of this role include excellent organization skills, flexibility, and the ability to thrive in an efficient, highly interactive, goal-oriented team environment, and working with minimal supervision. As a team member of the cell culture group you will work to support cell and tissue culture activities. The laboratory skills and training include expertise in mammalian cell culture, aseptic technique, sterile media preparation, tissue culture room maintenance, routine testing for endotoxin and mycoplasma.

The successful candidate will work as part of the innovation team of NantKwest to develop next generation products for adoptive cell therapy based on the allogeneic Natural Killer (NK) platform NK-92 . Perform research and associated laboratory tasks for projects and products. Work with other scientists to design and conduct experiments on a daily basis. Design and execute experiments with minimal guidance and supervision

Natera is currently seeking a Clinical Data Operator to join the operations team. This position accessions patient samples according to standard operating procedures (SOP) with high efficiency and accuracy. PRIMARY RESPONSIBILITIES: Create new orders on Laboratory Inventory Management System (LIMS) and perform necessary checks to ensure proper accessioning. Accession samples with high accuracy and efficiency. Accurately enter patient data into the Laboratory Inventory Management System (LIMS). Ensure that the information in LIMS is up-to-date. Scan test requisition forms and attached paperwork. Ensure that all paperwork belong to patient and upload to case. etc.

Natera is currently seeking a licensed Medical Laboratory Scientist to analyze specimens and maintains equipment in good operating condition. PRIMARY RESPONSIBILITIES: Verify the proper specimen being analyzed and perform tests that need to be completed. Proficient at analyzing clinical laboratory specimens following the standard methods and procedures in an efficient manner with little to no errors. Responsible for maintaining updated understanding and knowledge of methods performed in the lab. Provides general oversight of personnel and the daily operations in the lab. Meet expected performance metrics within role as applicable. etc.

Analyzes specimens and maintains equipment in good operating condition. PRIMARY RESPONSIBILITIES: Verify the proper specimen being analyzed and perform tests that need to be completed. Proficient at analyzing clinical laboratory specimens following the standard methods and procedures in an efficient manner with little to no errors. Responsible for maintaining updated understanding and knowledge of methods performed in the lab. Follows GLP (good laboratory practice): maintain clean and organized workspace. Completes training and other deadlines on time. etc.

The Associate QC Operation Trainer supports the operation training team through various tasks and responsibilities, while becoming proficient in various laboratory assays. Maintains an active list of every lab personnel’s current department and training logs ensuring all employees are properly and consistently trained and competent. Initiates initial training of new processes, document revisions, and products. Initiates the Read and Understood workflow of our quality documents through Veeva Vault, Confluence and our Learning Management System (LMS), and any other learning management system. Assists in providing training documentations/records as needed during audits. etc.

The Clinical Trial Assistant (CTA) will assist with the coordination of research studies, including maintaining Trial Master Files, tracking specimen procurement, tracking participant data and other study duties and organization. Maintain project and study-related documents including informed consent forms, clinical trial outlines, monitoring plans, synopses, IRB study protocols, and amendments, and clinical summaries, as required Follow protocol and assist with & coordinate training of study personnel on protocol and study manuals with external research sites

This position accessions patient samples according to standard operating procedures (SOP) with high efficiency and accuracy. Create new orders on Laboratory Inventory Management System (LIMS) and perform necessary checks to ensure proper accessioning. Accession samples with high accuracy and efficiency. Accurately enter patient data into the Laboratory Inventory Management System (LIMS). Scan test requisition forms and attached paperwork. Ensure that all paperwork belong to patient and upload to case.

The Production Technician is responsible for the safe execution of the day to day operations of the production plant. This position will work closely with other team members and be responsible for personal and plant safety, environmental compliance, commitment to continuous improvement in the quality of our product, cost control efforts and efficient operations of the plant. This position requires working 12 hour shifts including evenings, weekends and holidays. etc.

Perform transactions on corporate computer inventory control system and customer relations database based on requirements of the position. Provide important data to management for regular reports. Prepare tested assemblies for customer. Develop and/or design test processes/procedures based on product specifications. Proactively problem solves departmental related issues independently and mentors other technicians in this process

Responsiblities include: Test and calibrate assemblies to meet quality standards as well as perform electronic calibration and verify fixtures. Trouble shoot assemblies independently with exceptional computer skills. Maintain a strong commitment to high quality work with less than 2% failure rate on repairs. Maintain a 10 business day repair turnaround time on customer owned properties. Maintain minimum stock with refurbished parts to assure same day order fulfillment to assure best in class customer satisfaction

The Chemistry Laboratory Analyst II conducts testing in accordance with established procedures using Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and under the supervision of the Study Director. Additionally, Laboratory Analysts record data concurrently, maintain traceability of samples throughout testing and notify the Study Director of any unforeseen circumstances that occur during testing. etc.

The Laboratory Analyst conducts testing in accordance with established procedures using Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and under the supervision of the Study Director. Additionally, Laboratory Analysts record data concurrently, maintain traceability of samples throughout testing and notify the Study Director of any unforeseen circumstances that occur during testing.