Links to 1170 Entry-Level Biotechnology & Life Science Jobs

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.

Process incoming shipments from suppliers, ensuring accuracy of all product data. Aliquot product into vials and assemble kits for customer orders and global stocking. Work with colleagues across the business to resolve discrepancies quickly. Maintain accurate inventory levels using both manual and automated systems. Fulfill customer orders using internal systems and processes, ensuring accuracy of all products in all orders. Work with teammates to improve the efficiency and accuracy of any processes implemented within the Logistics Department using creativity and resourcefulness.

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 Mechanical Designer works under the direction of the Design Team Leader and also utilize independent judgment to perform the day-to-day project duties of designing, developing and releasing deliverables. This includes detail & assembly drawings and related bills-of material used in the fabrication of equipment for pilot and commercial scale biopharmaceutical manufacturing (largely pressure vessel assemblies for fluid & gas handling and motorized agitation systems). Primary responsibility involves generating design plans utilizing Autodesk Inventor and AutoCAD software. etc.

At Arbor, you will be at the cutting edge of biodiscovery, systematically searching through nature’s diversity to discover and engineer new technologies for improving human health and sustainability. As a Software Engineer in Research, you will focus on building a search engine from the ground up.  You will have significant latitude towards ideation, problem definition, and finding novel uses of machine learning.

The Research Associate I will play a significant role in purification of protein biologics, and report to the Purification Group Leader. Core responsibilities include maintaining and operating chromatography instrumentation, conducting hands-on research for development of new techniques, and supporting ongoing protein purification activities. The ideal candidate will have a passion for scientific innovation, excellent technical skills, execute their responsibilities with high attention to detail, and work well within a team dynamic in a high-performance culture. etc.

The Research Associate, Bioanalytical will provide bioanalytical quantitative analysis of test compounds in biological matrices obtained from a variety of studies including preclinical safety evaluations and pharmacokinetic evaluations. Focus on small molecule analysis using LC-MS/MS. Principal Duties and Responsibilities: Execute experiments by LC-MS/MS in support of drug discovery and early development programs following the SOP. The candidate will be responsible for sample preparation from biological matrices, tissue homogenization, sample extraction techniques, and data acquisition. Perform duties in a timely manner to achieve study timelines. Perform other duties as directed by Management. etc.

The Quality Control Technician will join Accelerate Diagnostics’ Consumable Operations team. This individual will be responsible for testing of incoming product both analytically and biologically in support of manufacturing. This will include, but not limited to, operation of pH/conductivity meter, spectrophotometer, refractometer and in-house biotechnology systems. This person will be part of a team that executes these tasks on a daily basisThe Quality Control Technician will join Accelerate Diagnostics’ Consumable Operations team. This individual will be responsible for testing of incoming product both analytically and biologically in support of manufacturing. This will include, but not limited to, operation of pH/conductivity meter, spectrophotometer, refractometer and in-house biotechnology systems. This person will be part of a team that executes these tasks on a daily basisThe Quality Control Technician will join Accelerate Diagnostics’ Consumable Operations team. This individual will be responsible for testing of incoming product both analytically and biologically in support of manufacturing. This will include, but not limited to, operation of pH/conductivity meter, spectrophotometer, refractometer and in-house biotechnology systems. This person will be part of a team that executes these tasks on a daily basis

The Quality Control Technician will join Accelerate Diagnostics’ Consumable Operations team. This individual will be responsible for testing of incoming product both analytically and biologically in support of manufacturing. This will include, but not limited to, operation of pH/conductivity meter, spectrophotometer, refractometer and in-house biotechnology systems. This person will be part of a team that executes these tasks on a daily basis. The ideal candidate will be a team player, demonstrate excellent communication skills, be flexible, and excel in a fast-paced environment. etc.

The Product Surveillance Specialist effectively implements the complaint handling process and processes complaints in a uniform and timely manner according to regulatory requirements and company practices and policies. Evaluates complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting and any other worldwide regulatory requirements.

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 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.

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.

The Manufacturing Associate performs GMP manufacturing operations safely, reliably and in compliance with stated processes.

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: Plasmid construction and large-scale plasmid DNA production. AAV vector production, purification and characterization. Design and develop new assays with minimal supervision. Maintain relevant laboratory supplies and equipment as needed. Draft SOPs, tech report and study reports. etc.

We seek talented Formulation Scientists at various levels to join our expanding R&D team who will be responsible for developing the final product formulation, process procedures and packaging of semisolids, suspensions and solutions, lotions, nasal sprays, inhalations, sterile injectable and ophthalmic products etc. Literature searching and review, patent searching and interpretation, performing risk assessment for formulation/process development, conducting experimental design and execution of lab scale, pilot scale developmental batches to support the final formulation and processes. Evaluation and selection of active, inactive raw materials and packaging components for various products. etc.

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.

We seek a talented Formulation Scientist to join our expanding R&D team who will be responsible for developing the final product formulation, process procedures and packaging of semisolids, suspensions and solutions, lotions, nasal sprays, inhalations, sterile injectable and ophthalmic products etc. Literature searching and review, patent searching and interpretation, performing risk assessment for formulation/process development, conducting experimental design and execution of lab scale, pilot scale developmental batches to support the final formulation and processes.

The quality control chemists perform testing on raw materials, bulk formulations, finished products, stability samples, and any other samples from plant operations that require chemical analysis. The QC chemists report to the QC manager. Responsible for the laboratory testing in accordance with company SOP’s as well as cGMP’s and GLP’s. Testing involves Raw materials, In-process, Finished product, and Stability samples for potency and physical characteristics such as pH, Specific gravity, Moisture, etc.

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.

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.

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.

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.

Responsible for working at the direction of the Chief Operating Officer and/or Managing Partner to help support the sales functions within the defined geography. Medical Sales Representative will assist in retaining and penetrating existing customers (surgeons and distributors) and finding new business. The Medical Sales Representative is responsible for field-based customer service, case coverage as necessary, and sales prospecting as assigned by the Chief Operating Officer and/or Managing Partner, generating new business, sales logistics, product knowledge, product training, and maintaining inventory assets.

Under routine supervision, this position is responsible for creating purchase orders and shipping inventory for outside processing. Counts and verify parts for outside processing. Packages parts safely for shipping. Creates purchase order for outside processing. Assists with cycle counts on raw materials, components, and distribution when needed. Conforms to all company policies and procedures and perform all duties in compliance with applicable FDA and state regulations as well as standards including but limited to ISO 13485.

The IT Help Desk Technician Level 1 is responsible for end user support, upgrades, customization, and system integration. First point of contact for troubleshooting of IT problems; resolving the problem if possible, with an appropriate sense of urgency. Provide IT support to end users, both on- and off-site.

The Programmer Analyst I is a computer programming position responsible for delivering technical services relating to clinical trials data. This includes working with Electronic Data Capture (EDC) and other data management applications to achieve project integrity and the delivery of on-time, quality data. The Programmer Analyst I analyzes the feasibility of program requirements to develop applications that meet FDA guidelines.

Research Associate II is responsible for assisting senior R&D staffs with minimal supervision to design, develop, and validate clinical diagnostic assays spanning a wide range of Next-Generation sequencing and microarray technologies.

As a software engineer at Ambry you’ll gain industry-leading experience in AGILE software development while working at the cutting edge of clinical genetics. At Ambry, you’ll have the opportunity to develop innovative solutions and leverage the latest technologies to make our diagnostics-testing even better. The technologies we use include Perl, Python, Dancer2, MySQL, MongoDB, and Elastic Search.  Knowledge of the genetics and/or genetic testing industry a huge plus and a sense of humor is a must.

Monitor compliance to in-house standard operating procedures (SOP's) and Current Good Manufacturing Practices (CGMP's), pertaining to the manufacturing, packaging, storage, and distribution of finished product.

The Automation Engineer reports to the Manager of the Automation group. The position is responsible for providing Automation Engineering support at the Amgen Thousand Oaks site. Provide system administration and ownership support for DeltaV and Utility systems. Work closely with multiple disciplines including: OIS network and site platform leads to support, plan and execute system roadmaps and as well as influence future improvements. Ensure optimal performance and reliability for process systems and equipment.

he Associate of Manufacturing will work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant supporting development, clinical, and commercial launch activities. Under general supervision, employee will perform operations in the Manufacturing area, specifically B23 processes. Operations will be performed according to Standard Operating Procedures (SOPs).

We are seeking an IS Engineer – Data Analytics in our Amgen Capability Center (ACC) Tampa, FL to join our Patient Safety IS team. The ideal candidate must be passionate about providing solutions for advanced analytics and data processing. You will collaborate with our Patient Safety business and product teams to define and build the reporting and data visualization solutions enabling faster and better-informed decision-making

The successful candidate will support the development and execution of in vitro and analytical biomarker assays to drive our discovery programs and provide critical support for clinical Gene Therapy programs in neurological lysosomal storage disorders. Support development of specific reagents for the characterization of lysosomal glycoproteins. Protein purification from mammalian cell lines. etc

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.

Assists in material handling, equipment set-up and breakdowns, documents process according to Master Production Records, and works with trained operators at assigned work centers to learn all aspects of the position, including batch record documentation, equipment set-up, operation and clean up.

This position works within the Finance Department is responsible for daily data entry as it relates to Contract Support related activities. This includes order processing, shipping paperwork, invoicing, advanced ship notices, product returns and other duties as assigned.

Develop optimum molding processes for manufacturing medical components. Provide recommendations and implement improvements to production processes, methods and controls. Provide support and leadership in the development of in the injection molding processes and tools.

The purpose of this position is to assist sales reps in making goal. Candidate must maintain an understanding of distribution channels and key industry leaders. Must be willing to travel as needed for tradeshows, conferences and in servicing events. Duties include training and in-servicing of customers and assisting sales reps as needed. This will involve up to 75% travel throughout the United States.

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

In this role, you will create PR/Marketing collateral, assist with website design, graphics, and plan publicity strategies and campaigns. You will be responsible for research, asset creation and organization to support corporate investor relations activities.

The successful candidate will bring hands-on experience developing assays and performing in vivo, ex vivo experiments. Animal handling techniques such as pharmaceutical agent dose administration (IV, PO, IP, IM) and blood/tissue collection are required. 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 be responsible for conducting in-vitro ADME studies, qualitative and quantitative analysis of small molecules using LC-MS/MS, to support multiple drug discovery and development projects. Responsibilities include, but are not limited to: LC-MS/MS method development and quantitative analysis of in vitro and in vivo samples in various biological matrices. Perform in vitro ADME assays such as metabolic stability, CYP inhibition, plasma protein binding and blood to plasma partitioning; develop new assays as needed.

The role will be responsible for executing a variety of experiments using in vivo models and in vitro assays in order to validate new targets and understand mechanism of action and pharmacodynamic properties of drug candidates. A successful candidate will contribute as part of a multidisciplinary team in a fast-paced environment to plan and execute experiments and subsequently collate, document, interpret, and present data internally. 

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.

The Quality Assurance Specialist I is responsible for helping to ensure compliance with QSR, MDSAP, ISO, GLP, and CLIA as they relate to Quality Assurance activities in Asuragen’s manufacturing facility. Provide Quality Assurance support to the Operations department with a focus on production. This is achieved though the following key duties: Develop working knowledge of quality system processes and apply this knowledge to support manufacturing operations. Assist in the management of historical files for manufactured products, including archived records stored on and off site

The Clinical Operations Associate position will be a key contributor to AtriCure’s clinical affairs department to assist in the development, implementation, and execution of multiple key study functions.  The Clinical Operations Associate primary responsibilities include but are not limited to device supply logistics, financial processes (contracts, budgets, and invoices), essential documents, trial master file (TMF), and select monitoring activities.  Responsibilities will vary by study.

Responsible for providing creativity to the mechanical engineering design and development of new invasive and non-invasive medical device products. Researches, develops, designs (utilizing CAD design software), and evaluates technical suitability of mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment. Must be able to clearly communicate designs and all requisite requirements to support personnel both verbally and in writing.

The Quality Assurance Associate Specialist/Specialist is an individual contributor who solves a variety of issues following cGMP regulations and company standards. Assist in the release of API batches and lots. Review of Manufacturing Batch Production Records - Must have at least 6 months to 1 year or more experience. Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs.

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.

We are looking for a talented individual to fill an Analytical Chemist position at our Ann Arbor, MI facility. Learn techniques spanning across the entire spectrum of analytical chemistry from wet chemistry to HPLC, NMR, Mass Spectrometry, FTIR, GC and GC-MS. Execute projects in support of client needs including product deformulation and product development, failure analysis and problem solving, impurity identification, extractable and leachable studies, and structural characterization

The Quality Engineer will provide quality engineering and quality assurance support for Manufacturing Operations to ensure new/improved and current medical products and processes are in compliance with applicable standards and regulations. Confer with external and internal departments (example Product Development, Clinical, Marketing, Sales, and Operations) concerning product design to ensure user needs are met. Implement Quality systems and processes. The Quality Engineer will write standard operating procedures, work instructions, and other Quality documentation.

Ideal candidates will exhibit, or have the willingness to develop, the following qualities: Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results. Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry. Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others.

The Validation Engineer will interface with our clients and be responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility and process equipment. This role will include both document development and field execution of test protocols, including FATs, SATs, CTPs, IQs, OQs, PQs, PVs. Required experience with good documentation practices, cGMP, & FDA CQV methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.

Conducts reviews of documentation and reports for conformance to procedures, protocols, and regulatory requirements.  Ensures training effectiveness in production. Provide Quality support with assigned projects and/or audits to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (GMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply.

This position designs, develops, and implements new products, processes, test methods and equipment. Initiates new or revised documentation and tracks through appropriate approval cycles and implementation. Maintains a professional working relationship with internal and external customer and support staff. Participates and/or leads cross-functional teams.

Scientist I is required to work within a team that develops automated assays using nucleic acid isolation and real-time amplification/detection technologies. Reporting to the Group Leader/Manager, the successful candidate will be responsible for assisting in the design, development, integration and/or qualification of assays on automated systems. The successful candidate may also be expected to provide support in execution of clinical studies to validate performance of the assays and assemble relevant information in support of regulatory submissions.

Research Associate II is an experienced and motivated individual. The RA II will characterize novel therapeutic targets for neurodegenerative diseases and assists in the development of potency assays and phenotypic screens in vitro.

The GMP Support Technicianwill perform a variety of tasks in support of the daily production of sterile cell therapy product. Operations are predominately performed within a cleanroom environment under Current Good Manufacturing Practices (CGMP) conditions. Provides operational support for manufacturing activities including media/reagent preparation, kitting, cell freezing and equipment/materials staging. Follow batch records, SOP’s and other cGMP documentation; complete all documentation in a clear and concise fashion

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 Inside Sales Representative is primarily responsible for achieving sales quota for ProteinSimple products, initially, Bioprocess (Maurice/iCE/MFI) system service contracts.  This person will be located at the Bio-Techne headquarters in Minneapolis, MN, interfacing primarily via the telephone and email with customers and potential end-users in the assigned territory. The secondary role is to gain proficiency on all ProteinSimple products to provide back-up support for field sales reps, and ultimately take on a full-time field sales position. 

The position involvesimplementation of HPLC, chromatography, enzyme assays, and gel-basedanalytical methods.Common tasks include analytical separations and quantitative analyses by:1) HPLC and column chromatographyincluding affinity chromatography, IEX, HIC, and SEC; 2) spectrophotometric enzyme assays; 3) sample preparation and extraction;and 4) basic antibody and protein analyses,usingELISA, protein extraction, protein concentration assays, SDS-PAGE, and Western blot.

The Procurement Associate will work directly for the Procurement Manager to assist in the operational procurement at the departmental level. He/She will own the procurement process for the department in scope and ensure compliance, budgets and corporate strategy.  He/She will have responsibility for negotiating pricing arrangements.  He/she will work closely with the finance, accounts payable, legal, and quality control.

Performs DXA analysis and quality control in accordance with study-specific deliverables and within study-specific turnaround times. Understands functions of software used to produce and collect DXA image analysis results. Communicates with Clinical Project Managers, Imaging Research Associates and/or Scientific Director regarding image quality, deliverables, and data discrepancies.

Test Processing Support Specialist 1 duties will consist of accurately and precisely transferring and entering data from test request forms into an electronic data base. Confirmation of entered data, and confirmation that data provided meets the minimum requirements as indicated by the QMS. Timely and accurate delivery of reviewed test results.

The Senior Quality Assurance Associate assists in execution of systems to assure cGMP compliance for all relevant operations carried out within and for BioDuro, LLC.  This function includes: Analytical Support – Support functions include, but are not limited to: review and approval of in-process testing, release testing of products, stability testing, other data summaries, method validation data, laboratory equipment validation protocols, product certificates of analysis, generation of environmental chamber monitoring reports. Other duties as deemed appropriate by Head of Quality.

This position will focus on development of high productivity and robust cell culture processes through classically and statistically designed experiments. The candidate’s goals will be to increase process robustness and productivity through comprehensive understanding of levers important to mammalian cell culture. A major component of the role will involve conducting and documenting laboratory bioreactor experiments with a focus on process definition and understanding, experimental design and troubleshooting, and data analysis. The ideal candidate will be able to work collaboratively with pilot scale and tech transfer teams for execution of development projects. In addition, the ideal candidate will contribute to improving laboratory process workflows, making laboratory work more efficient and with greater impact.

The individual will assist in the development and optimization of formulations and provide technical expertise on preparation procedures and mixing process parameters using both practical and scientific knowledge. Will work as member of dynamic team developing and following established procedures to ensure a consistent service is delivered. Management of department chemical and consumable inventories, ensuring proper levels are available. Frequent collaboration and communication with multiple line functions to develop solution formulations and preparation process instructions.

This position is responsible for developing immunoassay products in the Biomarker Immunoassay group. The Research Associate will be involved in all aspects of the product development processes including designing, initiating, testing, troubleshooting, testing materials manufacturing, technical instruction transferring, and product launching. More specifically, he or she will be working closely with an experienced scientist on developing a line of product utilizing ELISA or bead-based immunoassay and flow cytometry technologies.

The Material Coordinator is an entry level role that will support corporate business development efforts to expand company product portfolio through in-licensing, in-house development, and other methods of acquisition. This position will be responsible for documenting, receiving, and distributing incoming materials to stakeholders within the facility and outside locations and will work in a collaborative environment with other internal departments including Finance, Customer Service, Research and Development, Purchasing, Facilities and Quality Assurance.

The Research Associate will be involved in all aspects of the product development processes including designing, testing, troubleshooting, product transferring and launching. More specifically, he or she will be working closely with an experienced scientist on developing a line of product utilizing bead-based immunoassay and flow cytometry technologies.

The prospective employee will work in the Formulation Development group to assist in the advancement of BioMarin’s therapeutics for clinical evaluation and potential commercialization. The candidate will be responsible characterization drug products, screening of formulation prototypes, evaluating product stability and compatibility with various container closure systems using routine and semi-routine analytical methods under limited supervision.

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. 

Perform evaluation, refurbishment, assembly, alignment and acceptance testing of automated electro-mechanical biological test systems on an advanced level while maintaining stock levels.

Bio-Techne’s Protein Platform Division is looking for a Manufacturing Technician with a motivation to participate in the growth of a fast-paced company engaged in cutting edge biological research. The successful candidate will work with other members of the Reagent production team to make great products, performing tasks involving plate filling, labeling, vialing, and finishing materials. Operation of semi-automated liquid dispensing equipment is integral to the job.

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 microfluidic cartridges for biotech products. Operate and maintain cartridge fabrication process, with good manual dexterity. Document production batch records/travelers, and computer data entry

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.

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

The primary purpose of the position is to execute projects, perform routine experiments and analyze data in the Upstream Manufacturing Science and Technology (MSAT) group. The position holder must live the BI values and promote a positive work environment for others. Has discretion in tactical execution of process improvement projects, investigations and experiments. Frequently executes routine and occasionally complex experiments with sound scientific and engineering principals to resolve problems with minimal oversight. The Engineer frequently executes against specific deliverables developed by the department leadership to improve operational efficiency.

The Lab Technician in the Microbiology Lab 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 (including sterilization), equipment, and laboratory. Monitors and maintains water system, including sample collection for Bioburden, TOC, and Conductivity. Properly handles, stores and disposes of hazardous materials according to OSHA and Boston Analytical procedures.

he Chemist 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 using HPLC, GC, Dissolution, AA, UV-Vis, Wet Chemical Analysis and Method Development.

Provide Quality Technician support to Arden Hills commercial and development manufacturing lines ensuring delivery of the highest quality product to the customer while supporting continuous improvement projects and quality initiatives. This is a dynamic support role requiring cross-functional collaboration with production, manufacturing, and quality team members. This role includes responsibility for providing day-to-day quality support for manufacturing, including the processing of non-conforming product (identification, documentation, segregation evaluation and disposition), certifying builders and responding to quality signals.

This Quality Engineer role will investigate product complaints and monitor BSC product performance. The team uses product performance data to escalate post-market field performance signals into the CAPA process in collaboration with Return Device Analysis, R & D, Design Assurance, Medical Safety and the CAPA Management teams. This role provides for significant visibility across the quality organization

Primary focus is to build quality product by following processes to meet all production goals. Responsibilities include: Responsible for quality and adheres to manufacturing process requirements, the Boston Scientific Corporation Quality Policy and the Strategic Quality Process (SQP). Builds product by following all processes in which certified (in their most current revision), and completes other assigned work, while meeting manufacturing goals a8nd metrics. Under the direction of other maintains accurate records such as Manufacturing Execution System (MES), Shop Floor Paperwork (SFP), training Records System (TRS), Product Data Management (PDM), Systems Application & Products (SAP) and Process Equipment Optimization (PEO).

The Process Engineer I is responsible for developing and maintaining capable processes and ensuring efficient and effective sterilization operation. This person will provide problem-solving skills to enable sterilization innovation while using technical and collaboration skills alongside his/her passion for innovation and continuous improvement to drive growth through efficient and effective process improvements.

Daily planning operations supporting the manufacturing facility; planning for and ensuring availability of raw materials, components, and resources per the site’s detailed manufacturing schedule. Facilitate and coordinate activities with all departments to ensure the availability of raw materials for plant operations supporting development through commercial production. Review cGMP production records and perform associated inventory transactions in the ERP system.

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 systems such as DeltaV, Allen Bradley PLC 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.

Responsibilities include performing basic to moderately complex activities related to operating bioprocess manufacturing equipment, completing the associated documentation of those activities, monitoring assigned processes using automated production systems and controls. Other activities include keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities. Must be technically capable with a basic theoretical comprehension of general biopharmaceutical manufacturing equipment, principles and processes and have a basic understanding of current GMP and safety standards.

Associate I, Manufacturing is an associate with a moderate level of technical expertise and experience. Associate I may perform complex activities outside of routine manufacturing operations commensurate with their experience and training. Associate I participates in the day to day operation of a cGMP compliant Manufacturing facility. Responsibilities include performing basic to complex activities related to operating bioprocess manufacturing equipment, completing the associated documentation of those activities, monitoring assigned processes using automated production systems and controls under limited supervision. Other activities include keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities.

The Manufacturing Technology Associate Engineer will support Manufacturing Operations (Downstream processing, column packing) on a daily basis, as well as lead or contribute to strategic projects. Support projects and identify opportunities for productivity, robustness, quality, business process, and safety improvements. Regular and frequent on-floor observation to support and improve manufacturing.

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. Entry level engineer to develop new and improved Surgical Drapes and Gowns, Face Masks, Infection Control Apparel, sterilization wrap.

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 Associate Scientist, Quality Control Microbiology position requires a variety of skills necessary for biotech company operations. The position is an entry level laboratory role with the expectation that the candidate can be trained on technical procedures and once trained, execute them consistently and reliably. Additionally, this position will support Preventative Maintenance and basic Laboratory maintenance activities while maintaining a GMP quality system. The Associate will work on assignments that are primarily routine in nature but also provides support on projects and conducts lab work involving additional complexity.

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 offering enticing compensation incentives.  Work hours are Wednesday to Saturday (4/10).

A manufacturing associate’s primary duty is to perform a variety of operational tasks in accordance with current GMP's. Operators must work effectively in a team environment to achieve company goals and must adhere to all company compliance, safety, and attendance requirements. Safely operates equipment within a preparation area (i.e. cleaning, steamings, buffer/media prep, parts washing, autoclaving, etc)

The Catalent GOLD Program is a two-year rotational development opportunity designed for university graduates who are excited to accelerate their careers in an entrepreneurial, fast-paced and inclusive environment.   If you are ready to meet new challenges head on with creative solutions and unrelenting passion to deliver on the needs of patients around the world, join us. 

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 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 Associate (CRA) monitors activities at clinical trials sites to assure adherence to Good Clinical Practices (GCP), standard operating procedures, and study protocols. The CRA reviews regulatory documents as necessary, and prepares site visit reports. The person in this position is involved in the selection of potential clinical investigators and determines if facilities are adequate based on protocol requirements.

Assist in developing relevant enzyme assays in HTP format. Execute HTP screens to evaluate enzyme performance under application-relevant conditions. Analyze HTP samples in HPLC, UV-Vis Spectrophotometry, GC, LC-MS, or GC-MS to identify and quantify small-molecule products. Grow cultures, express proteins, and test enzyme activity in high throughput and in larger scales

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

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

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.

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.

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.

Operate a number of machines used in the manufacturing of pharmaceutical products and have a good working knowledge of elements used in association with batch production, such as equipment cleaning, running filling machines, etc. The operator is responsible for producing acceptable product that meets G&W internal standards, and is also in conformance with GMP and safety standards. 3rd Shift Hours are 11:00 p.m. to 7:00 a.m.

The Animal Technician provides primary care to the animals in the large animal toxicology department and performs routine invasive and non-invasive technical procedures on studies allocated to the team while ensuring that procedures are conducted according to protocol, SOP requirements, Good Laboratory Practice (GLP) and United States Department of Agriculture (USDA) regulations and the guidelines.

Learn to perform protocol, data and report reviews to verify conformance to applicable SOP and regulatory requirements. Learn to evaluate responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution. Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records).

Perform peptide related lab operation under close supervision. Assist in setting up and operating peptide related lab equipment. Perform HPLC, mass spectrometry, and other analytical techniques. Follow standard operating procedures (SOP) to perform various laboratory tasks. Complete training and development on an ongoing basis

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.

Provides calibration and instrumentation support for processes, operations, and buildings on site. Responsible to execute scheduled calibrations, preventive maintenance and corrective maintenance on instrumentation and control devices in compliance with facility procedures and work instructions. Works within clearly defined standard operating procedures and/or scientific methods and adheres to quality guidelines

Responsible for preparing the donor, donor area and equipment for the pheresis process. Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process. Maintains alertness and awareness to any reaction donor may have during or after the pheresis process and notifies appropriate staff.Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events.

The Clinical Safety Scientist I is responsible for managing serious adverse events (SAEs) in clinical trials or post-marketing programs, focusing on all aspects of the collection, processing, evaluating and reporting of cases in accordance with CTI’s Global Drug Safety and Pharmacovigilance processes, International Council for Harmonisation (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and study procedures. This individual will track cases from receipt to closure, perform verification of safety data, and will utilize clinical / pharmacovigilance judgment in coding of serious events and synthesizing complex clinical information into accurate and complete narratives.

This individual will also be involved in managing transgenic mouse colonies, maintaining transgenic lines for experimental purposes and designing, optimizing, and implementing new assays to measure cardiovascular system function. As a member of a multidisciplinary team, you will work closely with team members to identify, characterize and advance compounds through research and preclinical development.

Operation, harvest, and cleaning of stirred-tank bioreactors (AMBR15, 2-20L glass vessels, 50 L SUB, fed-batch). Media and reagent preparation to support upstream activities. Execute and evaluate of fed-batch cell culture studies in shake flasks and micro-bioreactors. Execute and evaluate of fed-batch cell culture studies in shake flasks and micro-bioreactors. Support of GMP mfg; may include BPR review and PIP duties

Executes upstream manufacturing of clinical and commercial products. Executes pre and post processing activities such as: clean of production equipment, including the operation of automated bioreactor, harvest and media prep skids. This position is accountable for executing the manufacturing processes in Contract Manufacturing Facility and/or Master Cell Banking Facility.

Performs research and/or development in collaboration with others to complete science-based projects. Makes detailed observations, analyzes data and interprets results. Investigates, creates and develops new methods and technologies for project advancement. Maintains high level of professional expertise through familiarity with scientific literature. May participate in scientific conferences and contribute to scientific journals. May be responsible for identifying patentable inventions. May act as principal investigator in conducting own experiments.

Supports development of new and modified sensor manufacturing processes. Assist lead engineers in defining processing or handling equipment requirements and specifications, and reviews processing techniques for manufacture of new products and to decrease cost, improve throughput, and improve overall quality for commercial product lines. Support transfer and work on process development/scale up or new products from R&D. Manufacturing support to identify and resolve technical issues. Involvement may begin from feasibility at vendors to full scale manufacturing.

The Business Development Manager is responsible for identifying new clients and for establishing and maintaining sales relationships. This candidate is also responsible for maintaining and strengthening relationships with existing clients. As a successful candidate, you will need to meet the following technical requirements and qualifications: Place outbound calls to market to qualify and build relationships with contacts, and secure meetings. Educate prospects on the eCaseLink suite of products and services.

Provide operational support to multiple functional departments; Facility, Finance, IT, QA, BD, PSRD, and Legal to contribute to the development and implementation of organization goals. Coordinate department, project ,and, business development client meetings and webinars, related luncheons, prepare and distribute meeting documentation. Schedule and coordinate with external vendors, i.e. Facilities and Manufacturing, for service requests

In this role you will contribute to the development of cell-based assays and ex vivo methods to evaluate gene editing. An ideal candidate should have a background in cell culture, ex vivo tissue dissection methods, and a strong interest in genome editing. Perform ex vivo tissue dissection and cell isolation. Perform routine DNA/RNA extraction and PCR, western blot, and ELISA. Development and optimization of cell-based assays

The Biologist-QC will provide technical support including consultation/recommendation on various analytical topics to management where appropriate.  He or she will support and sometimes manage laboratory related projects affecting QC.  The Biologist will assist other laboratory personnel in the implementation of new technologies into the QC lab and improvement of existing processes.  The Biologist will also coordinate non-routine analytic work and sample analysis to support relevant projects and initiatives when needed. The position will also include routine testing of in process and final product samples for the release of veterinary vaccines.

As a Laboratory Operator II, you will be responsible for high fidelity execution of detailed protocols. Operators are relied on for the immediacy and reliability with which experiments are run on the ECL, so attention to detail is crucial. The Lab Ops team relentlessly clears the queue of customer experiments and keeps the robots in the labs running at all times, with a focus on exactness and increasing efficiency. The entire ECL facility is run in a systematic way, and the team purview encompasses all protocols that enable this, from maintenance and control of instruments to inventory intake.

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.

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.

Works closely with the veterinary staff in supporting the nonhuman primate (NHP) colonies in Alice, TX. Monitors animal health and welfare with the opportunity to work with different NHP species. Position includes assisting all departments onsite including the hospital, behavior, quarantine, shipping and outside colony teams. Performs technical medical procedures in the various departments and assists the veterinary team in all aspects of animal care.

Conduct routine husbandry and animal health procedures in accordance with departmental SOP’s and maintaining USDA and AAALAC compliance. Operate the power washer to clean and sanitize runs, feeders, walls, building and floors per SOPs. Ensure that all occupied runs have adequate feed available at all times. Perform general house cleaning throughout the support areas. Humane care and treatment of animals.

The Medical Technologist will perform qualitative and quantitative tests and examinations using various analyzers and/or manual methods on specimen sources such as blood, urine, and other body fluids using established procedures. They will also be responsible for performing established quality assurance procedures (quality control testing, instrument function checks and calibrations). Maintains appropriate documentation and reports irregularities.

Perform assays on vaccine products, process intermediates, and related experimental samples using SDS-Page, Capillary Electrophoresis, ELISA, Biacor, nucleic acid quantification and other biochemical/analytical tests(e.g., spectrophotometric, electrophoretic, immunochemical methods). Maintain records and test results following good manufacturing practices (GMP).

he Associate Scientist position is an intermediate-level professional position involved in somewhat complex day-to-day activities in a laboratory setting under prescribed processes (protocols, standard operating procedures, methods, etc.). Responsibilities include completing work for research and development under CGMP and/or GLP guidelines for studies, documentation, etc. Assisting in conducting, monitoring and reporting studies to ensure data accuracy and report quality. Providing somewhat complex analytical work on projects and studies using a range of analytical techniques and instruments.

Assist the Study Director with all phases of study design, scheduling and conduct. Act proactively to identify problems and potential problems. Assist in writing, reviewing and editing reports, protocols and SOP’s. Set-up and conduct experiments in accordance with Protocol and SOP's. Efficiently carry out procedures necessary to complete each project with minimal supervision. Meticulously maintain precise records of all experiments in accordance with good laboratory practices.

Fill pails, drums, and totes with raw materials, intermediates, and finished products (including forklift operation). Run reactors/product blends per operating directions. Clean transfer lines within the plant and to the drumming station. Unload empty packages and stage for use, load box trailers with product for transfer. Maintain good housekeeping, perform housekeeping audits, run karl fisher analysis on titrators, and assist in filter change-outs, perform fork-lift inspections, etc.

Apply process engineering knowledge and skills to support the synthesis of starting materials pharmaceutical intermediates and final bulk products in a safe, efficient and environmentally responsible manner. Specifically, the process engineer is responsible for demonstrating process understanding, monitoring, and managing process performance.

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.

This role assists with financial operations and reporting in Global Strategic Outsourcing Department. Responsibilities include supporting the Associate Director with contract administration, budget estimates, payment processing and reporting to facilitate the outsourcing strategies and activities of the Research & Development Organization. This role also requires the ability to obtain appropriate information to administer contracts and payments for outsourced agreements and communicates regularly to internal and external stakeholders on status of contracts and payment requests.

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

Fate’s clinical operations group is seeking amotivated and talented individual to support development and management of an electronic trial master filesystem(Veeva)and assistour clinical trial managerswith administrative and project-specific support related to the conduct of clinical studies. The successful candidate will assure adherence to protocol(s) and GCP/ICH guidelines and applicable regulations. The ideal candidate will be familiar withphase I-IV protocols and have hands-on experience in developing and maintaining electronic clinical trial management systems.

Responsible for process equipment engineering, overseeing, guidance, scheduling and coordination required to fully implement process equipment engineering projects in order to support manufacturing, QA, Tech services, IT, Procurement, other departments, external vendors and government agencies as required. The incumbent is considered a Subject Matter Expert (SME) responsible for all aspects of production equipment (complete sterile manufacturing train) and its interfaces including mechanical, electrical, process plumbing, and safety interfaces. The incumbent must have superior troubleshooting and problem solving ability to ensure minimal down time and interruption to production schedule. The incumbent interacts with Production, QA, Tech services, IT, and other departments as necessary obtain all applicable stake holder(s) information and decisions to collaborate high quality low risk results.

Assist with troubleshooting, root cause analysis and identification of corrective actions to support Pharmaceutical Development or GMP Manufacturing equipment and process issues. Support efforts to scale-up & undergo technical transfer of production processes to GMP Manufacturing. Lead planning, execution, and documentation of studies related to design of novel drug products. Work cross-functionally across Quality, Research, Clinical, and Manufacturing teams to achieve company goals.

The Biology Team at FORMA Therapeutics seeks a Research Associate/Senior Research Associate with a strong background in cancer biology to contribute to FORMA’s pre-clinical and clinical projects. The ideal candidate will be a highly motivated individual with a strong technical background in cancer biology. Develop, optimize and perform assays using molecular biology procedures and technologies including qPCR, quantitative western blots, ELISA. In vitro culture of cancer cell lines and primary cells as well as blood/tissue is required.

We are currently looking to add to our Clinical Lab staff at various levels and shifts. Perform highly complex testing according to established SOPs (NGS library prep, hybridization, and sequencing). Operate automated 8-span and 96-head liquid handling platforms for sample processing. Complete projects fitting of level of expertise and is able to deliver results with minimum guidance.

The Client Services Representative is a vital position at FMI tasked with the responsibility of responding to and resolving a wide range of client inquiries and requests as well as acting as a liaison between departments within FMI, and between FMI and its partners, customers and the patient. The incumbent operates in a supportive function within the fast-paced Client Services department.

The Chemist, Method Development has broad expertise in routine as well as complex chemical methods of analysis. The incumbent conducts all aspects of Quality Control testing including method development, method validation, experimentation, routine and non-routine quality control testing, and record keeping. The incumbent must be able to develop, validate, and implement methods that meet project needs. The incumbent is typically assigned the more complex test methods due to their advanced training in specialized methods of analysis. The position is responsible for conducting studies with increasing complexity in nature and solving problems to ensure a robust method can be performed in the laboratory.

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. The individual must 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.

Responsible for the operation and performance of high speed pharmaceutical equipment in a clean room (class 100) environment. Aseptic Control Operators are responsible for the cleaning, changeover, setup, startup, operation, and breakdown of filling lines. Additionally, they may be assigned tasks related to the general upkeep of the clean rooms, such as unloading ovens and sterilizers, performing routine cleaning, and performing minor maintenance. All of these activities are governed by strict procedures and regulations and require a high degree of training. Therefore, Aseptic Control Operators must complete all required training, and follow all applicable Standard Operating Procedures, Batch Records, and Protocols, and must be familiar with current Good Manufacturing Practices.

Hand assemble manufactured components. Complete required documentation for work performed. Quality inspect work performed. Follow defined work procedures. Provide suggestions of continuous line/process improvementsHand assemble manufactured components. Complete required documentation for work performed. Quality inspect work performed. Follow defined work procedures. Provide suggestions of continuous line/process improvementsHand assemble manufactured components. Complete required documentation for work performed. Quality inspect work performed. Follow defined work procedures. Provide suggestions of continuous line/process improvements

Associate Scientist / Bioanalytical Services Essential Functions Provide support for running sensitive, reliable and efficient LC-MS/MS bioanalytical assays for TK/PK assessment. Coordinate study activities with Responsible Scientist to ensure efficiency and quality. Maintain the proper level of regulatory compliance for each study, helping to address QA audit findings

Perform assigned tasks per procedures compliant with cGMPs and participate in the clinical manufacturing of parenteral, ophthalmic, and other sterile dosage forms. Assist with manufacturing area maintenance such as area monitoring and qualification, purchase of gowning supplies, purchase of equipment and room cleaning supplies, microbiological monitoring supplies. Assist in the equipment set up, operation, maintenance, cleaning as required for the project

We are hiring for a Powder Formulation Tech. The Powder Formulation Tech is responsible for the formulation of our company’s powder cell culture media products. NOTE: The current opening is on our second shift (1:00 PM – 9:30 PM). Formulates Powder media formulas per manufacturing protocols utilizing various weighing equipment such as scales and balance. Uses Mettler-Toledo IND780 terminal system to ensure correct raw materials assigned in the batch record are used and at the specified quantity. Reviews lot folders for accuracy, completeness and availability of components necessary to complete job prior to the scheduled date of production

Executing Development and Production processes as well as process documentation. Understanding processing principles and scientific theory behind operations steps. Demonstrating proficiency at the advanced skill level. Troubleshooting of equipment/processes. Authoring and routing SOP’s for approval. Assisting in the execution of validation protocols.

Writes and revises Standard Operating Procedures (SOPs) and other related Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP) documentation. Manages test samples, reagents and reference standards. Provides QC support for the Sample receipt for Manufacturing. Perform other duties as assigned.

The Upstream Process Development group is seeking an Associate Scientist with experience in microbial technologies. An Associate Scientist assists in conducting experiments for programs. The individual monitors on going experiments and can identify unusual occurrences. An Associate Scientist understands and applies knowledge within area of expertise and can take an active role in non-routine process development activities.

The Clinical Trials Assistant (CTA) is responsible for providing support to the lead Clinical Trial Manager and the study execution team, clinical tracking and document maintenance as applicable to study vendors and clinical trial sites. The CTA will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in compliance with GBT SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.

The Laboratory Technician performs an entry level role in the testing of clinical DNA specimens for the purpose of diagnosing genetic disease, using manual and automated methods in a team environment, and following established policies and procedures in a professional manner.

A GeneDx NGS Lab Technician performs a higher than entry level role in the testing of clinical DNA specimens for the purpose of diagnosing genetic disease using manual and automated methods in a team environment, and following established policies and procedures in a professional manner.

Generation Bio seeks a highly motivated Research Associate to support analytical molecular biology activities in a cross-platform function. The successful candidate will work part of an analytics team responsible for the development and testing of research drug substance, as well as performing experiments to better characterize and understand the composition of our drug. Perform bioanalytical assays, including purity, copy number, expression, and activity assays to support the Production, Pre-clinical, and Process Development groups

Quality driven processers. When our customers send us samples for sequencing, they help to prepare and process these samples as quickly and as awesomely as possible, while maintaining the highest quality standards in the industry. They prepare DNA templates which include preparation, amplification and PCR purification and load these samples onto the sequencers. They also work to prepare buffers and other related solutions.

When our customers send us samples for sequencing, they help to prepare and process these samples as quickly and as awesomely as possible, while maintaining the highest quality standards in the industry. They prepare DNA templates which include preparation, amplification and PCR purification and load these samples onto the sequencers. They also work to prepare buffers and other related solutions.

GENEWIZ is seeking technical sales professionals to join our New Jersey/New York based Sales team. Achieve annual sales goals within defined territory/accounts through the development, maintenance, and enhancement of customer accounts. Develop and implement an effective territory business growth plan. Retain current business baseline revenue by managing relationships with customers and other account contacts by collaborating with business leaders and the customer interface teams

Prepare amplified template libraries for high-throughput sequencing. Carry out DNA sequencing on next-generation DNA analyzers. Perform routine maintenance of DNA analyzers and related equipment. Check inventory and replenish consumable sequencing supplies . Communicate with customers by phone and e-mail in a friendly and professional manner

This position conducts incoming, in-process and final release QC testing in a controlled manufacturing environment. This position may also execute validation studies, execute test protocols, analyze data, generate analytical reports, investigate Non-Conformance's, evaluate processes & procedures, utilize statistical techniques, review specifications, and inspect & test equipment. May conduct training on quality related tools, methods, and procedures. Interfaces with R&D, Manufacturing, Quality, and Supply Chain within the company and when appropriate with customers and suppliers on quality related issues.

Genomatica is seeking a highly motivated Research Associate I/II, Microbiology/Molecular Biology to join the Strain Engineering team. This team is responsible for construction, characterization, evolution and characterization of host strains. The successful candidate will utilize her/his knowledge of Microbiology/Molecular Biology for cloning genes, genetically engineering chromosomal DNA, sequencing and analyzing the genome, characterizing product titers, growth and by-products when grown with various feedstocks.

We are looking for a Laboratory technician to assist our daily production tasks. The successful candidate should have biology or related science background, excellent time management skills, strong problem solving ability. He or she will need to work directly with production team, fit with collaborative and competitive culture in GenScript.

GigaGen seeks a talented, highly motivated Research Assistant to work alongside PhD-level scientists on research funded by a $50 million co-development deal with Grifols, plus Phase II SBIR grants from the NCI and NIAID. This project involves high-throughput discovery and development of therapeutic antibody drug candidates from human and mouse immune repertoires. The work involves significant cell culture work, including a bioreactor and flow cytometry.

We are looking for someone who is excited about the field of synthetic biology and loves a challenge. We want a person who is eager to learn and has a desire to utilize automation to work more efficiently. Our ideal candidate will elevate our team through creative solutions while working closely with other foundry groups. Responsibilities include: Enzyme purification and characterization, Data analysis, Automation of protocols

Lead/manage assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study. Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance. Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits

Develop, Implement and Install filter integrity testing methods to available automated Filter Integrity Testers (FITs) available on site to verify the integral of the vent filters that will used in the process for WFI Tanks, Autoclaves, supply clean compressed air and as required. Prepare protocols and reports for Validation Project Plan, Validation Master Plan, IQ, OQ, OQ, Traceability Matrix, Engineering test Plans, and Commissioning test strategies following the site Good Data and Documentation Practices (GDP) during protocol execution for qualifying the system or facility

Execute Validation and Qualification protocols which include installing, operating and maintaining of GMP Lab Equipment and Instruments (HPLC, UV-Vis Spectrometers, FTIR, GC, pH meters, Conductivity meters, Analyzers etc.) and manufacturing equipment like sterilizers and autoclaves to confirm if the instrument is compatible and compliant with Manufacturing, analysis, Company and FDA regulations. Perform validation and qualification documents include User requirement specifications, functional requirement specifications, Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validation summary reports, Change Control etc. for various lab instruments utilized by Quality control and Quality assurance teams;

Performing hands-on daily submission compilation and publishing activities associated with preparation of various dossier types and safety reports, for both new product marketing applications and/or marketed product maintenance packages. Performing overall quality of the assigned documents and dossiers which must comply with all internal Bayer best practices, meet global regulatory requirements, and facilitate the review and timely approval by appropriate regulatory authorities. Supporting the compilation of global dossiers and to deliver technically compliant submission documents/reports, which contribute to the development of submissions that meet the technical requirements and standards set by relevant health authorities.

Responsible for strategic and operational activities of clinical research studies in blood cancer metabolism to ensure adherence to intended timelines and achievements of study goals, while ensuring quality by FDA, EMEA, ICH and GCP guidelines. Providing oversight in clinical research Organization (CRO), Central labs and other external vendors to ensure deliverables are met and methods of communication are developed to facilitate an efficient workflow. Facilitating interdisciplinary activities, participating in the clinical trial working group (CTWG), Site Management Team (SMT), and internal team meetings to meet the goals and established timelines

The Mechanical Engineer, Research & Development will support the Critical Care Mechanical team working on new product designs, technology development and sustaining of core product lines with an emphasis on hands on new product development.

Assists Upstream Manufacturing and Cell Culture Operations with Manufacturing in accordance with Master Batch Records and in compliance with GMP regulations and guidelines. Monitors Manufacturing Processes, Operates Analytical Laboratory Equipment and provides Operational Support for USP-MFG activities. Compiles electronic /laboratory notebooks, maintains laboratory equipment, and equipment logs and monitors supplies.

W.L. Gore & Associates Inc. is seeking an associate to join the R&D Technician Lab Team at one of the Fabrics Division’s facilities in Elkton, Maryland. The primary focus of this commitment is to support projects and hands on testing needs for our Durable Water Repellent coating on laminates. Performing lab functions accurately and efficiently, including but not be limited to: Hands on testing, sample preparation, and test method development. Writing and implementing procedures.Operating and maintaining analytical equipment

The Clinical Research Assistant coordinates the research and administrative activities of clinical trials for Gradalis. The Clinical Research Assistant works for the Clinical Operations Manager to provide support in compliance with the FDA Code of Federal Regulations (CFR), the ICH Good Clinical Practice (GCP) Guidelines, OHRP/DHHS guidelines and Gradalis Standard Operating Procedures.

As an Equipment Engineering Technician, you are responsible for supporting laboratory equipment management procedures, in alignment to our internal Quality Management System, to ensure better performance within Laboratory Operations. This will include global laboratory equipment support, sustainment, and operations activities across Production/Clinical, Product Development, Research and Development laboratories, in accordance with CLIA/CAP, FDA, cGMP and/or GLP guidelines.

Responsible for performing various routine manufacturing tasks following established procedures and cGMP regulations under guidance of a production supervisor and/or senior management. Follow production and manufacturing procedures. Perform equipment preparation, bulk drug formulation, and aseptic filling duties as needed. Train in various manufacturing tasks including, but not limited to: fill/finish, formulation, lyophilization, sanitization, component and equipment preparation, and finished product inspection and packaging activities.

Research Associate 2 is responsible for designing and performing experiments while collaborating and communicating effectively. Performs moderately complex experiments with input from supervisor. Able to summarize related groups of experiments. Provides input to the experimental design. Is able to analyze experimental data with minimal input from supervisor. Interprets experimental results in context of overall experimental goal.

You assist in determining the suitability of donors to undergo plasmapheresis prior to venipuncture. You establish rapport with donors to ensure overall customer happiness with the center to support long-term donation, all while ensuring donor confidentiality. Sets up, disconnects, and operates the automated plasmapheresis machines including response and evaluation of all autopheresis troubleshooting displays, documentation of exceptions, etc. Ensures the proper calibration and maintenance of autopheresis machines and associated equipment. May be trained to repair plasma equipment. Disconnects and disposes of all contaminated disposable equipment. Ensures proper cleaning of equipment and work area between donors. Maintains accurate and thorough documentation of production records.

Identify and screen donors by reviewing medical records and logs and evaluate the donor as to suitability. Screening includes asking health related questions and referring to medical staff when necessary; taking vital signs (blood pressure, pulse and temperature), performing fingerstick (HCT & Total Protein), and reviewing results using the applicable donor management system Maintain donor confidentiality at all times in all areas. Responsible for preparing donors for plasmapheresis procedure. Review donor record files for accuracy and completeness. Collect plasma by setting up the autopheresis instrument, performing the venipuncture and utilizing an Automated Plasmapharesis machine. Evaluate vein performance by checking data with known norms to identify possible problems; make corrections in order to expedite donation time and ensure product quality. Conducts all phlebotomies in compliance with all federal, state, and Biotest regulations.

You assist in determining the suitability of donors to undergo plasmapheresis prior to venipuncture. You establish rapport with donors to ensure overall customer happiness with the center to support long-term donation, all while ensuring donor confidentiality. Sets up, disconnects, and operates the automated plasmapheresis machines including response and evaluation of all autopheresis troubleshooting displays, documentation of exceptions, etc. Ensures the proper calibration and maintenance of autopheresis machines and associated equipment. May be trained to repair plasma equipment. Disconnects and disposes of all contaminated disposable equipment. Ensures proper cleaning of equipment and work area between donors. Maintains accurate and thorough documentation of production records.

As Production Maintenance Technician you will be responsible for maintaining, troubleshooting, calibrating and modifying electrical and mechanical systems and equipment and document work on mechanical, electrical, hydraulic, and pneumatic equipment involved in the manufacture and packaging of pharmaceutical products.

As an Automation Engineer, you will manage and execute projects related to industrial machine automation for both new and existing equipment. Lead the design and installation of instrumentation and control systems in some of the following areas: building automation systems, data systems, process control, DCS and utility PLC’s which are harmonized with GSK-standards. Provide technical support for existing instrumentation and automation systems. Analyze repairs and maintenance requirements in order to proactively address system weaknesses.

Development and quality of critical reagents, including characterizing external antibody’s, building isotype-specific antibody reagents, purifying proteins, conducting protein conjugations (e.g. biotin, ruthenium and fluorescent labels), assessing their purity and affinity, and generating certificates of analysis (CofA). Monitor reagents life cycle and characterization to assist with reagent trouble shooting effort.

As Calibration and Instrumentation Staff you will be responsible for supporting the team to ensure manufacturing systems are current on calibration requirements.  You will also assist the team with the calibration process system, laboratory equipment, and facilities related utilities.

The Reporting Assistant (RA)II is responsible for assisting the reporting Clinical Laboratory Scientists (CLS) and supporting the daily operations of the post-analytical reporting process.The RA IIis responsible for preparing all preliminary reports, labeling folders, documenting controls for CLS review and assisting sample status in the Clinical Laboratory.

The entry level firmware engineer is an integral position within the Hach R&D team. The engineer will be part of a fast paced team, working in a collaborative environment that will drive growth and innovation within the firmware competency. The engineer will engage with SCRUM in an Agile team environment with the core responsibility of developing high quality innovative solutions.

We have an immediate opening for an IT Support Technician to be based out of our corporate office in Buckhead, GA.  This is a full-time position and will be responsible for managing  HealPros's equipment in our facility or at the location of our technologists. Under the supervision of the IT Administrator, the IT Support Technician will perform troubleshooting techniques to resolve equipment issues and maintain it in good working order.

Performs repetitive assembly/fabrication/materials tasks using basic hand tools to build either parts for or actual temperature-controlled storage units, refrigerators/freezers and thawing systems, Cleans and packs units, handles material for distribution. Regular and reliable attendance, which includes punctuality and working scheduled overtime, is necessary to meet our commitment to provide quality products and service to our customer. Ensure that device history records are completed according to FDA GMP requirements. Complete nonconformance records according to established procedures and GMP requirements.

Performs repetitive assembly tasks using basic hand tools to build temperature controlled storage units, refrigerators/freezers and thawing systems or under counter temperature controlled storage units. May clean and pack units.

Assist in conduct of clinical studies. Provides licensed nursing coverage for studies and performs procedures as allowed by training and delegation. 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.

Performs the set of tasks referred to as “window work” within the Chemstore while collecting, washing, and redistributing laboratory glassware. Escalates any washer issues discovered to the GMP department and communicates shortages/inventory needs to their Manager.

The primary duties of a Medical Equipment Service Representative involve client facing customer service and minor medical equipment repairs. Responsible for the pick-up and delivery of medical equipment, using a company provided vehicle to customer facilities. Periodically work on an on-call rotation that involves a 24/7/365 operation. Responsible for direct customer contact

The role of Analytical Development Research Associate is to aid in developing and refining analytical methods to characterize AAV vector products. The individual in this role will be a highly-skilled, talented and motivated researcher who will focus on the analysis of research/development-grade vector samples using multiple AAV-specific analytical methods. The candidate will participate in the comparison of AAV vector products produced internally with those produced externally as well as the optimization and qualification of molecular and bioanalytical assays such as HPLC and capillary electrophoresis.

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. 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.

As a Laboratory Assistant will assist and aid the technical staff with handling and accounting for biological lab specimens, reagent inventory, and any other relevant tasks. Assists with retrieval and set up of samples for analysis. Receives samples from Sample Management and segregate and distribute to the lab as per standard operating procedure. Monitor Sample Logistic Scan/pending list and search for lost samples. Troubleshoot issues with Sample Management when required. Member of the Lost sample Team.

Our Configuration & QC Specialist plays a key role within ICON Laboratory Services (ILS). Support the Project Management Team (PM) in configuring and QC'ing new studies in all ILS systems according to the specifications of the Client Laboratory Worksheet (CLW) and create all supporting documents and site instructions to facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables and study specific Lab Manuals.

Our Configuration & QC Specialist plays a key role within ICON Laboratory Services (ILS). Support the Project Management Team (PM) in configuring and QC'ing new studies in all ILS systems according to the specifications of the Client Laboratory Worksheet (CLW) and create all supporting documents and site instructions to facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables and study specific Lab Manuals.

This unique opportunity is designed for individuals with a Bachelor's Degree in Life Sciences, strong organizational skills, excellent written and verbal communication, and working knowledge of computer systems including Microsoft Word, Excel, Outlook, and PowerPoint. ICON, a leading Clinical Research Organization, is seeking passionate, resilient and inspiring Graduates to join our team as a Clinical Trial Assistant. This opportunity offers an entry-level permanent position to highly skilled individuals interested in a career in clinical research.

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. Our Configuration & QC Specialist plays a key role within ICON Laboratory Services (ILS). Support the Project Management Team (PM) in configuring and QC'ing new studies in all ILS systems according to the specifications of the Client Laboratory Worksheet (CLW) and create all supporting documents and site instructions to facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables and study specific Lab Manuals.

This unique opportunity is designed for individuals with a Bachelor's Degree in Life Sciences, strong organizational skills, excellent written and verbal communication, and working knowledge of computer systems including Microsoft Word, Excel, Outlook, and PowerPoint. ICON, a leading Clinical Research Organization, is seeking passionate, resilient and inspiring Graduates to join our team as a Clinical Trial Assistant. This opportunity offers an entry-level permanent position to highly skilled individuals interested in a career in clinical research.

Our Configuration & QC Specialist plays a key role within ICON Laboratory Services (ILS). Support the Project Management Team (PM) in configuring and QC'ing new studies in all ILS systems according to the specifications of the Client Laboratory Worksheet (CLW) and create all supporting documents and site instructions to facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables and study specific Lab Manuals.

You will be using microtomes, processors, embedding centers, automatic slide stainers and other diagnostic tools to perform tissue analyses that diagnose animal illnesses and diseases in support of veterinarian animal treatment.  You will be responsible for transforming a tissue sample into a slide that will be read by a board-certified veterinary anatomic pathologist. It is expected you will follow SOPs (Standard Operating Procedures) and maintain a safe working environment.  

The Medical Laboratory Technician performs laboratory analyses and tests. Prepares samples, sets up instruments, runs tests and reads, interprets and releases results. May perform variety of customer service activities for internal and external customers. Testing cell-related components of blood samples to enumerate and identify their cellular components, including the microscopic evaluation of blood smears and the use of automated and manual counting techniques. Processing blood and body fluids for microscopic examination by pathologists. Includes slide preparation and staining, utilizing manual and automated counting techniques.

Synthesizes oligos on various synthesizer platforms. Cleaves and deprotects oligos utilizing appropriate methods. Quantifies and samples oligos for quality control tests. Attaches modifications utilizing various techniques. Adheres to safety regulations, lab SOPs, and contamination controls.

Immucor is seeking a Medical Laboratory Technologist to join our Quality Laboratory team. The Medical Laboratory Technologist is responsible for performing laboratory testing (including potency, specificity, reactivity and hemagglutination assays) and chemical evaluations (including protein, absorbance, chloride, osmolality, and pH) of Immucor products according to approved Standard Operating Procedures (SOP’s) within defined timeframes.

Immucor is seeking a Medical Laboratory Technologist to join our Quality Laboratory team. The Medical Laboratory Technologist is responsible for performing laboratory testing (including potency, specificity, reactivity and hemagglutination assays) and chemical evaluations (including protein, absorbance, chloride, osmolality, and pH) of Immucor products according to approved Standard Operating Procedures (SOP’s) within defined timeframes.

The primary purpose of this second shift position is to provide support to the sample management group in a QC laboratory setting in support of commercial manufacturing. Responsibilities of the QC Sample Coordination Technician include collating receipt of samples and coordination of testing, preparation of samples using aseptic technique, organizing and tracking lot release data, submission of samples to contract testing laboratories and tracking sample custody.  Activities include equipment maintenance, coordinating with Shipping and Receiving, and receipt of test results from contract laboratories.

The Production Support Associate is part of our production team. The Production Support Associate supports our production team by assisting in the main production area. Performs various routine production tasks under the guidelines of established SOP’s and CGMP regulations. Prepares components needed for production, such as washing vials, wiping of supplies needed for the clean room. Performs cleaning and disinfecting of manufacturing and clean rooms per established procedures.

The Clinical Specialist is responsible for calling on practicing physicians, hospitals, clinics and other health-related organizations within an assigned territory.  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.  Accomplishments of these goals must comply with the terms and conditions outlined in the Company Policy and Procedure Manual.

Assists with the activities required to manufacture autoimmune diagnostic products by following established procedures. Major duties include the manufacturing of tissue sections and their placement onto glass microscope slides for use in Immunofluorescent Assay products. Participates in all activities associated with the manufacturing of the tissue sections and their placement onto glass microscope slides in accordance with written documentation and established procedures. Manufactures 8.5 eight-well ANA Plus Slides per hour after three months of training. 10 eight-well ANA Plus slides per hour within one year of employment. Thereafter, manufactures 10.5 slides per hour for eight-well slides and 21 slides per hour for four-well slides (all tissue types). Assists with the activities required to manufacture autoimmune diagnostic products by following established procedures. Major duties include the manufacturing of tissue sections and their placement onto glass microscope slides for use in Immunofluorescent Assay products. Participates in all activities associated with the manufacturing of the tissue sections and their placement onto glass microscope slides in accordance with written documentation and established procedures. Manufactures 8.5 eight-well ANA Plus Slides per hour after three months of training. 10 eight-well ANA Plus slides per hour within one year of employment. Thereafter, manufactures 10.5 slides per hour for eight-well slides and 21 slides per hour for four-well slides (all tissue types). Assists with the activities required to manufacture autoimmune diagnostic products by following established procedures. Major duties include the manufacturing of tissue sections and their placement onto glass microscope slides for use in Immunofluorescent Assay products. Participates in all activities associated with the manufacturing of the tissue sections and their placement onto glass microscope slides in accordance with written documentation and established procedures. Manufactures 8.5 eight-well ANA Plus Slides per hour after three months of training. 10 eight-well ANA Plus slides per hour within one year of employment. Thereafter, manufactures 10.5 slides per hour for eight-well slides and 21 slides per hour for four-well slides (all tissue types).

The Assistant, Clinical Trials (CTA) is responsible for supporting, under the direct supervision of the supervisor/Clinical Project Lead (CPL), clinical trial execution, investigator sponsored research and program level activities as assigned within Clinical Operations at Inovio. This position assists in various tasks and projects related to clinical trials as well as basic, administrative duties.

Initiates, directs and manages the design, development, constructing and modification of products and processes from conception to implementation. Works closely with other departments to coordinate design engineering activities. Reviews, initiates or approves engineering drawings, layouts, changes orders and specifications.

Performs deburr, finishing, and cleaning in a job shop or high volume applications. Processes components to meet print and or geometric tolerance requirements. Responsible for the setup, operation and maintenance of production equipment needed for deburr, finishing, and cleaning operations, maintenance of proper documentation, and support of the manufacturing engineering function. Under close supervision, completes tasks as directed by SOPs, routers, prints, work instructions, and manufacturing schedules.

The accountant position is responsible for performing a combination of cost and general ledger accounting and financial close tasks, as assigned. Perform the monthly financial close process for the local ledger, including preparation of the monthly journal entries and balance sheet (cash, inventory, payables) and P&L account reconciliations, as assigned. Run various reports used to reconcile or analyze general ledger account balances. Assist in the preparation of the standard monthly management reports. Perform detailed monthly variance analysis on items in the P+L and balance sheet.

Our company is in an exciting growth phase where we are launching new products and reaching new markets. To support our growth, we seek a Business Development Associate to help launch new partnerships, businesses, and growth strategies. Successful candidates will also be involved with our marketing and sales teams to assist with strategic growth plans.

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)

Intrexon Corporation is seeking a highly motivated Research Associate, Plant Traits with molecular biology skills for our growing Agricultural Biotechnology Division (ABD) at Davis, California. The candidate will join a team to work on innovative technology to develop various traits in crops. The successful candidate will have hands-on experience with molecular techniques as well as supporting the senior scientist to develop other methodology to enable high-through-put, low-cost genotyping in multiple crops. Strong technical, organizational, and communication skills, as well as the ability to develop creative solutions to challenging problems in a fast-paced, milestone driven company, are essential.

Partner with Manufacturing to develop and sustain a well-trained and flexible workforce through hands-on training, mentoring, and formal certification. Maintain accurate manufacturing and training documentation to ensure the effectiveness of the training process. Develops and prioritizes quarterly training plans based on input from Production and Training Supervision. Conducts training, mentoring and formal certification of production technicians in accordance with S & V Training DOP’s and Manufacturing Process Instructions.

The Clinical Territory Associate (CTA) will work closely with the Clinical Sales Manager to gain knowledge in all aspects of our business to include technical, clinical, and sales. He or She will train to be a da Vinci® Surgery technical and sales expert across all primary surgical specialties to develop surgical robotics programs in the assigned territory. During the first year of the job, the CTA will focus on the technical and clinical aspect of the job, and during the second year of the job, the CTA will progress and begin to focus on the sales aspect of the job. The CTA will have the opportunity to support a specific region by maximizing the utilization of installed da Vinci® Surgical Systems by leading product demonstrations/in-services and sales activities.

Invenra is seeking a highly motivated laboratory support technician. This individual will maintain the laboratory and laboratory supplies in a clean, ready and working order. The position will work collaboratively with others to implement process improvements that increase efficiency and quality in the laboratory. This is a part-time position.

The Histology Technician works in the laboratory to perform and support ex vivo studies including, but not limited to, histology, autoradiography, 3D fluorescence imaging, and cell culture. The ideal candidate will have hands-on experience in a pharmaceutical histology laboratory performing standard histology studies – embedding, sectioning and chromagen/fluorescent antibody staining. In addition, the ideal candidate will have a proven track record and competence in histology or autoradiography method development. The individual in this role will be expected to understand and carry out analysis to inform his/her own development efforts and assist in-house analysts.

As a Manufacturing Associate I/II for Invivoscribe you will assist with all aspects of production, including the production of master mixes, controls and assay kits. You will contribute to the drafting and review of new documents, including SOPs, Batch Records and Purchasing Specifications. Details include: Oversee, perform, plan and schedule production. Work with suppliers of core raw materials to ensure quality, quantity, price and availability. Create, review and revise production documents. Implement and train on the use of those documents. Participate in the production of master mixes and ASR, reconstitution of oligonucleotides, controls, reference standards and general purpose reagents by following manufacturing batch records, work instructions, standard operating procedures, forms and validated Excel spreadsheets.

As a for a Quality Control Laboratory Associate I/II at Invivoscribe you will be responsible for receiving samples and performing data entry for specimens received as well as performing all aspects of clinical laboratory patient testing. More specifically: Test raw materials in process and final product and generate testing data. Releases products to QA for final approval. Ensure that all customer complaints and inquiries are resolved. Conduct and maintain the real time stability study testing.

We are seeking a motivated and talented Research Associate to perform laboratory assays for validation of potential drug development targets and characterization of pharmacological compounds. The Research Associate should have excellent laboratory skills to conduct in vitro bioassays on murine tissues and primary cells. Experience with tissue culture techniques and primary cell-based assays are required with a variety of readout technologies including flow cytometry, RT-PCR and ELISA. Excellent communication skills and motivation to learn are essential. Ability to work in a highly interactive and multidisciplinary team environment.

Vaccine Sales RepresentativeThe Vaccine Sales Representative will be responsible for achieving stated business goals of product sales within assigned portfolio and geography through strategic territory and account management and building solid working relationships. Responsible for providing healthcare providers with all relevant information that promotes quality healthcare decisions. Maintains an expert product knowledge base including patient education, consumer education, and factors influencing the market environment. Understands and uses approved promotional materials to support marketing message.

Work closely with Development, Functional/Business and QA teams in all the phases of SDLC. Review the requirements and provide the QA estimations and raise any concerns or issues as needed . Involved right from the requirements grooming and will prepare the logical test scenarios & test cases as needed. Prepare test scenarios & test cases and requirements traceability matrix (RTM) to ensure the complete coverage

Develop superior product and disease state knowledge and effectively educate and engage healthcare professionals in dialogue about clinical evidence, approved indications, and product efficacy/safety profiles to support on-label prescribing for appropriate patients. Representative must demonstrate a strong understanding of relevant disease states and possess a solid ability to communicate necessary technical, scientific, and product and disease management information to customers. Drive sales performance in a compliant manner and work to meet or exceed territory sales goals through execution of regional and national marketing strategies

Support scientific staff with various protein characterization methods including SE-HPLC, sub-visible particle analysis (HIAC and Flowcam), protein concentration (UV-Vis), pH, osmo, buffer exchange and viscosity. Execution of established high throughput biophysical methods. Perform lab maintenance tasks will include buffer preparation, tracking/ordering consumables, and shipping/receiving samples.

This team member will be responsible for the manufacture of mammalian cell-based biotherapeutics for clinical use under cGMP conditions. Under direct/moderate supervision, job responsibilities include set-up, operation, and maintenance of disposable-based manufacturing equipment; execution of manufacturing process operations; and assist in general lab operations. The staff member is expected to comply and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation.

Responsible for a wide variety of cell-related functions, including producing cells, intermediate product, and manufacturing final product for commercial distribution. Follow SOPs, perform daily tasks in a clean-room, retain records and write reports. May also be responsible for troubleshooting. Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP’s and batch records. Responsible for various duties that are required to produce product including but not limited to cell expansion; cell feeding, harvesting, counting and freezing; product seeding; growth system maintenance; labeling, packaging and freezing of product; and culture media preparation. Follow specific techniques and operations while demonstrating an understanding of cGMPs and how they apply to specific responsibilities.

The successful candidate will apply scientific and engineering principles to support new biopharmaceutical process enrollments into the cGMP manufacturing facility. The candidate will: Perform all aspects of facility fit activities to support program enrollment including generating process flow diagrams, bill of materials (BOM), new specifications, and Äkta chromatography methods. Collaborate with process development and manufacturing teams to perform technical transfer and facility fit activities for downstream processes.

This position is for a 2-week cycle, day shift with every other weekend off. Coordinate and perform cGMP manufacturing operations for biopharmaceutical products. Ensure the effective use of material, equipment and personnel while making products with the highest quality.Assist in execution of procedures for microbial manufacturing, purification, or support area of manufacturing using SOP's and batch record. Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures.

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.

KSQ Therapeutics, Inc. is seeking an exceptional and highly motivated Associate Scientist, Target Discovery/Validation in the Immunobiology group to apply their experience in immunology towards the development of the next generation of impactful immunotherapies. This person will contribute to both target discovery and target validation efforts as well as in supporting our pre-clinical Immuno-Oncology small and large molecule portfolio.

Person exhibits aptitude in assisting in the development of topical product pharmaceutical formulations, as well as meeting timelines for the department. 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.

This position will work both in the processing of cytology samples for testing, as well as working in the accessioning department to receive samples. Processing of samples by loading them into instrumentation to make slides. Handling/Processing/Centrifugation of laboratory specimens, primarily blood and urine specimens. Running image guided slides through imager to prepare for testing

Perform routine and complex technical procedures and functions according to departmental Standard Operating Procedures. * Monitor, operate and troubleshoot instrumentation (can include specific dept instrumentation) * Demonstrate the ability to make technical decisions regarding testing and problem solving. * Able to resolve technical, computer, and customer service problems within the specified department. * Deliver quality patient care while maintaining efficiency. * Perform preventive maintenance and quality control with appropriate documentation and communication. * Assist in processing of specimens when needed.

The successful candidate will be able to execute hands-on laboratory work in cell culture including planning and executing shake flask, bench scale bioreactor, bench scale purifications and large-scale bioreactor experiments. The position requires a drive to provide outstanding customer service by maintaining regular communications with clients, meeting or exceeding quality and timeline expectations.

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.

The Laboratory Technician is an integral part of the Laboratory Operations team and through collaboration with others is responsible for executing the objectives of the Research and Development group. This position will be involved in conducting lab experiments as assigned and be responsible to accurately document results. The Laboratory Technician may be asked to assist in preparing standard laboratory procedures, keep detailed record of experiments, and will report on project results to relevant stakeholders. The Laboratory Technician is expected to be familiar with the scientific background and literature relevant to the projects they are engaged. The work of a Laboratory Technician is directed and evaluated by a senior R&D laboratory member.

We are seeking a Research Associate level candidate to support media production and to handle and clean glassware and perform the appropriate cleaning services required for each piece of glassware. This individual will perform machine washing, handwashing, dry sterilizing, autoclaving, plugging and oven and air-drying of glassware. Plus prepare diverse media to support the discovery and scale-up fermentation teams.  The incumbent will be enthusiastic about working in an exciting start up.

To produce veterinary biologics according to a defined production schedule following cGMP guidelines and specific outlines of production to meet market demands for Aquaculture products. Comply with safety requirements, cGMP, SOP and manufacturing documentation. Produce antigens in a timely manner according to their approved Outline of Production/Product Dossiers and to cGMP guidelines. Support Antigen production and freeze dried vaccines production according to Standard Operating Procedures and Protocols.

Partner with health care professionals and those involved with patient care as a product expert to tailor solutions for patient therapy. Sell in a changing health care environment, utilizing critical thinking and a strategic mindset to understand the environment (payer, health systems, business) and gain access to the customers to make an impact on patients’ lives. Work in your own territory and also partner with team members and alliance partners for success in the territory

The Clinical Research Associate in collaboration with the Clinical Trial Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs.  Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.

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.

The Microbiology Technician will be responsible for (1) Verifying that materials and products comply with microbial and/or chemical specification limits (2) Conducting laboratory testing in support of operations, (3) Maintain the laboratory operations in compliance with McGuff policies, federal regulations, state regulations, and international standards, (4) Maintain documentation, calibration, and validation of all microbial equipment, (5) conduct other duties as assigned by the laboratory supervisor and/or Microbiologist. etc.

As a Entry Level Sales Executive, you will be responsible for maintaining and growing a client base of both hospital and physician customers for MDL. Responsible for achieving annual sales and profit objectives for a defined territory. Obtain new business and exceed annual territory sales budget each year by presenting new test information, up selling and seeking out new sources of revenues from clients. Develop and present personalized sales presentations to professional audiences (physicians, laboratory staff, clinics and group practices); demonstrate how MDL's technical features and services could benefit the practice and help medical personnel provide quality patient care.

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. That's right, I said Life-saving! This is only going to happen one way you have to have a solid work ethic and be able to focus on the clinically significant signs and symptoms of one or more patients while in a noisy environment that is full of interruptions. 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.

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.

Performs the assembly or sub-assembly of medical devices and products in an advanced position under moderate supervision from line leaders and supervisors in accordance with manufacturing documents and verbal instructions. Using written and verbal instruction to assemble and package product. Records data associated with the building of product on builds records. Ability to meet quality standard. Perform job function within production standard on 2-5 operations. Work with engineers and supervisors to perform special assembly requests

The Engineer I/Engineer II, Manufacturing Process is responsible for the improvement, sustaining, development, and overall support of new and existing manufacturing processes for new and existing products, product changes and enhancements, as well as related tooling and fixtures. Supports validation of product, equipment and processes. Interfaces with other departments to solve production problems. Monitor equipment maintenance program. Investigation and testing of product processes. 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.

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.

Mission Pharmacal Company, a pharmaceutical manufacturing company, is seeking an energetic Product Handler Trainee to join our team in Boerne, TX. Responsibilities include performing assembly/production, warehouse/receiving, distribution or manufacturing functions.

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 person will be responsible for assisting in the maintenance and function of the quality management systems at MD Biosciences. This person should have a background in and knowledge of quality systems in a laboratory setting and preferably have experience in aCLIA &/or GLP-regulated environment. etc.

This Quality Assurance Specialist position is responsible for the operation and compliance of the training program within the Quality Management System (QMS). The incumbent will provide assistance within the department to support Document Control initiatives and the management of document change order packages. 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. etc.

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.

Independently perform routine test article/product preparation and execute routine testing and perform routine calculations per NAMSA SOPs, and according to applicable work instructions. Prepare or participate in the preparation of test specifications in conjunction with the requirements of the applicable standards and/or client instructions. May have direct client contact as needed. Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and for taking all concerns to management as required. Accurately collects and records raw data in logbooks and on worksheets. etc.

Principle duties/responsibilities include: May perform routine test article/product preparation and execute routine testing and perform routine calculations per NAMSA SOPs and work instructions. Accurately collects and records raw data in logbooks and on worksheets. May be responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures. May be required to perform personal gowning environmental testing, and submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing as applicable.

Primarily involved in the welfare and husbandry activities of animals, including sanitation of equipment and the vivarium. Receives, identifies, and acclimates laboratory animals. Follows the Quality Manual, all NAMSA SOPs, and Process documents. Documents all required tasks. May administer treatments as directed by staff veterinarian.

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 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

Assist in the development of client deliverables according to project requirements, including but not limited to, project-specific documentation, operating procedures, and work flows with direction of more experienced staff. Process incoming and outgoing project materials to monitor, verify, and track receipt of documentation and ensure appropriate distribution of materials to internal and external research personnel and sites. Prepare general correspondence, agendas and meeting minutes, reports, and other project-specific documentation. Ensure review, approval, and distribution to internal staff and external project participants.

Performs laboratory tests and services to support customer data generation through sample processing and DNA extraction. Uses a variety of scientific techniques, instrumentation, and disciplines by performing the following duties: Performs sample and reagent preparation, DNA extraction and isolation, quality analysis prior to genotyping, analysis of reagents for performance, and other related tasks. Assist in the training of new assistants and interns in order to better manage laboratory workload. Proficiency in providing input to the best ways to maximize laboratory efficiency. etc

The QC lab technician position requires the candidate to prepare microbiological media and buffers. Other responsibilities include; prepping and cleaning the laboratory for daily use, perform preventative maintenance on equipment, maintain and organize QC retains and meeting goals set by the department. The ideal candidate would have some laboratory experience.

The ideal candidate will possess a knowledge of instrumentation such as FTIR, HPLC, UV/VIS, and KF to be used in the routine analytical testing of samples supporting incoming raw materials, in-process production, finished product, and validation. The selected candidate will be responsible for performing instrument/method troubleshooting as well as validation, qualification, calibration, and preventative maintenance, and performing investigations on out-of-specification and out-of-trend results. The selected candidate will participate in QA functions of the QCU including document review, room and equipment log review, room cleaning approvals, and other quality functions as assigned by the Director of AS Quality Systems.

Performs laboratory tests and services to support customer data generation within the platform specific processing lab, through a variety of scientific techniques, instrumentation, and disciplines by performing the following duties: Preforms all duties essential to quality high throughput data generations associated with platform specific technology-including but not limited to assigned primary platform and/or secondary platform(s). Gain and maintain the ability to operate all electronic and robotic equipment essential to primary platform processing. This includes all hand held electronic repeaters, multichannel pipettes along with liquid handling robots. Maintain consistency and quality in lab techniques and procedures within an ever changing and fluid work environment.

As a Clinical Laboratory Technologist I or II or III you will work under general supervision and you will be responsible for accurately performing highly complex laboratory testing procedures. You will determine acceptability of specimens for testing, prepare clinical specimens and identify specimen related problems. You will also analyze specimens, review and release test results. You will have the means to prepare stock solutions, reagents and cocktails used in the laboratory. You will then test these based on standard criteria and document all observations.

As an Order Entry Specialist I, you will enter patient demographic characteristics and insurance information into a proprietary database using company specific software and internal documents. Additionally, you will input diagnosis codes, charges and verify insurance in accordance with company policies.

As a Laboratory Assistant you will assist the department technologist in performing various basic laboratory procedures laboratory instrumentation to facilitate production. This in an entry level position in the clinical laboratory job category and employees in this position may not manipulate samples.

As an Accessioning Technician I you will ensure proper handling of all specimens received and prepare specimens for laboratory testing. You will be performing functions such as matching patient information, data entry, and scanning documents. You will be responsible for reviewing all requisitions for missing information, working closely with Customer Care in order to obtain missing information in a timely fashion, and distributing new information to all departments involved. You will need to report problem holds and provide resolution in a timely fashion. etc.

As a Histotechnologist I or II, you will work under general direction to precisely and accurately conduct a variety of routine and specialized histology procedures. You will research, troubleshoot, and resolve histology related inquiries and problems within the laboratory. This position requires you to produce the highest quality of embedding, microtomy, tissue grossing, tissue processing, and H&E staining, special staining, immunohistochemistry staining and equipment maintenance. etc.

Position Summary: Perform microbiology department related tests according to USP methods and established procedures that follow cGMP guidelines and demonstrate outstanding aseptic techniques. Demonstrate high proficiency level on tests performed. Additional work duties or responsibilities as evident or required. Performs other duties as assigned or apparent. Apply quality scientific techniques in the microbiological analysis of raw materials; in-process & finished product samples to include: sterility, bioburden, identification, environmental monitoring, growth promotion, microbial recovery and media fill tests following approved procedures. etc.

Manufacturing Associate, Labeling and Packaging are required to have a strong knowledge of process development experience, work flow understanding, Labeling Reconciliation, Reading and Understanding Labeling and Packaging Specifications. Carry out work in accordance with defined Quality Management System procedures and be fully supportive of Quality initiatives. Prepare room for staging, packaging, and reconciliation. Assist in maintaining fixtures, packaging tools, packaging instrumentation, such as scanners, scales, etc. in packaging areas.

he ideal candidate must have outstanding written and verbal communication skills, a strong work ethic, and be able to multitask and prioritize responsibilities. The position requires a working knowledge of many automated components of the HTS platform utilized at Neurocrine. This candidate must be able to independently manage their workload, while simultaneously working with his/her supervisor to provide consistent support to the in vitro team on multiple new target screening and lead optimization campaigns.

NGM Biopharmaceuticals, Inc. is seeking a highly motivated Research Associate to join our Nonclinical Safety development group. This will be a temp to full time position.

The Regulatory Operations Senior Associate will be responsible for maintaining timelines, formatting & publishing documents, assembling and building Regulatory eCTD submissions such as original INDs, IND amendments and/or CTAs and overseeing & archiving submissions. All will be done in accordance with and requires knowledge in applicable Regulatory Agency regulations, guidelines, and/or specifications (FDA, EMA, ICH, etc). Responsible for formatting, editing, proofing, bookmarking and internal document hyperlinks according to guidance and internal processes. Troubleshoot and resolve complex document issues.

Execute chemical processes for preparation and delivery of clinical candidates. Follow instructions in protocols and development batch records. Prepare reagents for chemical processes. Work with process development scientists and team leaders to execute process development experiments. Adhere to all environmental health and safety policies. Establish working relationships with project teams to satisfy demanding process development timelines

We are currently offering a unique opportunity for a highly motivated researcher to join our team with experience in immune, in vitro, cellular and cancer biology. JOB DUTIES AND RESPONSIBILITIES: Conducts pharmacological evaluation of test agents (cell products or small molecule) in subcutaneous, systemic and orthotopic in vivo oncology models. Assists in sample processing, homogenization, or generation of single cell suspensions for ex vivo flow cytometry analysis or PCR analysis. Contributes to preclinical research through development or validation of new tumor models. etc.

We are currently offering a unique opportunity for a highly motivated development associate to join our team with development experience in cell therapy. Responsibilities include: Support process development of phase appropriate cell therapy production processes. Evaluate raw materials and culture systems for use in cell therapy manufacturing processes. Support process optimization efforts to increase process robustness, reduce costs and improve yield. Design and execute experiments independently; accurately record, analyze and communicate data to senior staff and team members

The QC Associate is a key position within the organization with significant prospects for career growth as the company continues to increase the breadth and scope of its business. This position reports directly to Sr. Vice President and a Consulting Quality Assurance Unit. Responsibilities include butarenot limited to: Become and maintain intimatefamiliaritywith all applicable FDA and EPA GLPand other appropriate regulations and guidelinesas well as with the company SOPs and other QA systems. Supervise day to day quality control operations and documentation. etc.

Position consists of manufacturing of medical components in a clean room environment while under general supervision in accordance with specifications and written procedures. This position may include machine operation, manual production using hand tools, visual inspection, physical measurements, and packaging of finished product. This position requires the ability to work with small and delicate components using a high degree of dexterity and accuracy. This position requires direct contact with medical grade components.

Position consists of manufacturing of medical components in a clean room environment while under general supervision in accordance with specifications and written procedures. This position may include machine operation, manual production using hand tools, visual inspection, physical measurements, and packaging of finished product. This position requires the ability to work with small and delicate components using a high degree of dexterity and accuracy. This position requires direct contact with medical grade components.

Evaluates mechanical and electromechanical systems and products by designing, applying principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials. Develop mechanical and electromechanical products by studying customer requirements. Design custom equipment based on standard products. Identifies, analyzes and resolves a range of complex problem types.

The Quality Control Chemist I: Performs routine testing to assess the conformance of raw materials, finished products, and/or stability samples to predetermined product specifications. Performs routine testing in conformance with approved procedures, accurately and concisely documents data, and reports results. Demonstrates a basic knowledge of SOP’s and GMP regulations as related to the pharmaceutical quality control laboratory. etc.The Quality Control Chemist I: Performs routine testing to assess the conformance of raw materials, finished products, and/or stability samples to predetermined product specifications. Performs routine testing in conformance with approved procedures, accurately and concisely documents data, and reports results. Demonstrates a basic knowledge of SOP’s and GMP regulations as related to the pharmaceutical quality control laboratory. etc.

We're looking for a detail oriented QC Analyst I. The ideal candidate will be proficient in method validation and equipment qualification with minimal supervision, as well as performing chemical testing for raw material, water and in-process samples supporting the manufacturing process. Demonstrates self-starter and independent worker with strong commitment in quality and compliance. Excellent analytical and wet chemical techniques. Strong team player with the ability to communicate effectively both verbally and in writing. The person will join our Analytical team to support routine testing such as SDS-PAGE, FTIR, HPLC/UHPLC, ELISA, UV-VIS and others. etc.

We are seeking a Research Associate with experience in cell biology and immunology to join our Nurix drug discovery team. Nurix is devoted to unlocking the therapeutic potential of the ubiquitin system to explore the possibility of modulating targets previously believed to be “undruggable”. Ubiquitin ligases play numerous roles in immune cell function, autoimmunity, inflammation and anti-tumor immunity. The successful candidate will support early drug discovery efforts in inflammation, oncology and immuno-oncology (IO). etc.

Maintain cell cultures and cell banks; produce, concentrate, and characterize lentiviral, retroviral, and non-viral vectors for gene delivery into cell lines and primary cells. Organize and execute laboratory experiments, according to high scientific standards. Work with project teams to collect and prioritize production requests; organize and maintain inventory of lentiviral and retroviral stocks. Maintain accurate and detailed laboratory notebook and documentation.

The Endoscopy Support Specialist I maintains responsibility will be to obtain core Olympus product, service and operational knowledge during initial training period. He/ She must successfully complete specialized customer service training to develop customer relationship building skills to provide customer endoscopy support activities, successfully attend and complete a structured training curriculum which will include classroom instruction and hands on equipment practice and evaluation. The Endoscopy Support Specialist l will also learn and implement repair service strategies within a discreet territory that will provide customer assistance in reducing service contract costs, support service contract renewals and create opportunities to increase repair service market share.

You will spend time creating a complete solution for customers across a wide variety of industries and applications. Your expertise in product applications, equipment demonstrations, and creating a value proposition is critical for our customers. You must have an entrepreneurial drive to target, educate, and persuade customers to use Olympus innovative product solutions. You will know when and how to introduce other Olympus technical experts and industry specialists to our customers as part of your strategy to win.

The Microscopy Sales Associate functions as a resource for the customer and identifies customer needs based upon detailed discussions. Using product and application knowledge, the incumbent provides solutions to meet their needs.  He/She also installs and trains customer using equipment purchased.

The OCI Endoscope Technician I must understand and accept the responsibility to ensure the safety of all Olympus products that are repaired, by following established processes and procedures. The incumbent shall evaluate, troubleshoot, disassemble, assemble, repair and/or inspect Endoscopes, Electronics, or Microscopy products to assure proper function.

The Inside Sales - OmniPod Associate role is responsible for all patient communication during the sales process of starting patients on the OmniPod system.  This role works closely and collaborates with the field sales and internal team members to provide the best patient experience possible.  This role is responsible for communicating insurance benefit guidelines and cost share information with patients and assists them with their decisions regarding insulin pump therapy.

The Clinical Services Specialist (CSS) is primarily responsible for meeting all clinical initiative expectations.  This responsibility will require extensive travel and extended stays in a field based territory to support open territory needs. The CSS will provide product sales, training, downloading and technical support in accordance with company policy.  They will also in-service physicians, mid-level staff, CDE’s, and ancillary staff on the OmniPod Insulin Management System, build relationships with our customers, and skilled at selling and using the OmniPod Insulin Management System. 

This position is integral to supporting the department through complaint software enhancements, upgrades, report creation, data structure, and validation activities/documentation.  The BA will be the primary connection to IT resources supporting the business unit.  The BA will have a strong understanding of the business unit’s processes, context surrounding why the processes are in place, and what happens if processes are not functioning/followed.  The BA will be an expert in the systems utilized by the business unit and understand the implications of system structure, how changes may impact systems, and how system data is utilized for reporting. 

The QC Analyst I/II performs quality activities in support of product production and releases. The position has interaction with other internal departments, including Quality Assurance, Validation, Calibration, Materials, and Logistics. The position also has interactions with external entities including contractors and suppliers. The QC Analyst I/II performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, and reporting results. etc.

The Human Tissue Processing (HTP)  Production Associate I is an entry level position.  The HTP Production Associate I will perform the production activities associated with HTP Products, produced at Organogenesis Norwood, with supervision. The associate will adhere to the appropriate SOPs, MBRs, and cGMP procedures in the general lab area as well as the Class 10,000 clean room.  The HTP Production Associate I will report to the HTP Supervisor.

Responsible for supporting sales growth in specific assigned accounts within a territory or territories.  Success is realized by building strong customer relationships primarily through case coverage, conducting consultative sales calls, utilizing current product and disease state technical knowledge, developing and following an account business plan, and reporting sales related activities to management through a call reporting system. This position will be responsible for sales support and case coverage inphysician offices, clinics, hospitals and ambulatory surgery centers in the defined geography.

The QC Analyst I/II performs quality activities in support of product production and releases.  The position has interaction with other internal departments, including Quality Assurance, Validation, Calibration, Materials, and Logistics.  The position also has interactions with external entities including contractors and suppliers. The QC Analyst I/II performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, and reporting results.

The qualified candidate will support company’smolecular biology operations,principally performing DNA cloning and molecular biology experiments following protocols. Perform experimentsfollowing protocols for plasmid DNA purification, DNA digestion, gel electrophoresis,DNA fragment purification, ligation, transformation, DNA quantitation,DNA sequencing,PCRand cell culture

The qualified candidate will support company’smolecular biology operations,principally performing DNA cloning and molecular biology experiments following protocols. Job Requirements: Perform experimentsfollowing protocols for plasmid DNA purification, DNA digestion, gel electrophoresis,DNA fragment purification, ligation, transformation, DNA quantitation, DNA sequencing, PCRand cell culture. Responsible for assigned lab duties, maintaining lab stocks, solutions, reagents, and supplies. etc.

Perform receiving inspection on incoming materials, in-process, and final inspection of Orthofix subassemblies and finished products. Perform receiving inspection on incoming materials. Read, comprehend, and follow inspection procedures, drawings, sampling plans, and workmanship standards. Perform in-process and final inspection of subassemblies and finished products. Adhere to FDA/ISO requirements, safety, and corporate policies.

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.

Pacific Biosciences is seeking a talented Senior Manufacturing Technician to align, test, and calibrate complex opto-mechanical DNA sequencing systems. Responsibilities: The Manufacturing Technician is responsible for building and testing complex third generation DNA sequencing instruments. Manufacturing technicians are responsible for on-time completion of assigned instrument builds while following a tightly defined process for recording test results, documenting encountered issues, and troubleshooting issues to resolution. Some additional responsibility may include highlighting process improvements, redlining documents, and providing feedback to manufacturing engineers. etc.

Candidate will perform analytical testing to support product development of pharmaceutical inhalation devices. RESPONSIBILITIES: Assist higher level analysts with product or method development work. Follow established methods to complete stability testing. Provide testing of customer products using HPLC, UPLC, and some GC. Comply with FDA guidelines and SOPs in a cGMP environment. etc.

We are currently recruiting for QC Associate, reporting to Manager of Quality Control. This position will be based in South San Francisco.

Highly experienced in an analytical development and/or QC laboratory with a track record of successful development of PCR-based, ELISA-based, and/or flow cytometry-based methods for GMP and GLP use, including creating analytical development plans and experiment design, generation of test procedures, qualification/validation, and establishing product specifications and critical quality attributes and limits.

The Chemist II, under general supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation. Detects, participates and reports on OOS/OOT/NOE and other investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. May train less senior staff. etc.

This role is responsible for Quality Control Cell Culture testing to support Phase III/Commercial GMP manufacturing operations and Drug Substance/Drug Product release. Works in a fast-paced environment supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance and sterile finished drug product. Perform adherent and cell culture testing in a Phase III/Commercial GMP Manufacturing facility. Includes but is not limited to: thawing, enumeration, passaging and cryopreservation of various cell line types required for QC assays.

Sampling of raw materials according to established specifications. Sample coordination and receipt from other departments for internal and external testing. Scheduling of QC testing and activities. Sending out of test samples to Contract Testing Laboratories (CTL). Works closely with Manufacturing, Analytical Development and Process Development for scheduling of samples submission to the QC lab. May also interact with Project Managers on sample coordination

Quality Associate I or II (QA Floor Support) is responsible to provide Quality Assurance support real-time for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed. etc.

Entry manufacturing engineering role in a dynamic and fast growing manufacturing company. Working with advanced products and processes in the revolutionary life sciences and medical instrumentation industry. Providing technical support to our manufacturing operations to overcome challenges and implement solutions.