Links to 493 Entry-Level Biotechnology & Life Science Jobs

Monitor 23andMe's contracted laboratories for both commercial testing and research projects;Follow up on R&D projects in the contracted laboratories for regulatory agency submissions.

The person hired for the position of Manufacturing Engineer will provide technical leadership and manufacturing support within the Plastic Molding and Assembly Plant. This position will be supporting development and deploying of new or improved process technology, new product development, cost reduction and quality improvements. In this position, the person is responsible for driving operational excellence within the areas of support and is expected to initiate and conduct broadly defined technical tasks within the process technology platforms. They are also responsible for advising, consulting and troubleshooting area processes within the plant.

The person hired for the position of Manufacturing Engineer will support the Personal Care Division in the IATD business as a part of the Film Manufacturing & Supply Chain Organization (FMSCO) from within the 3M Menomonie Facility. The person will be part of a team supporting the personal care business in producing hook products for multiple customers throughout the world.

The person hired for the position of Quality Engineer / Technologist will work and interact with other cross functional team members (lab, plant manufacturing, manufacturing technology, regulatory, quality systems, etc.) on quality assurance of our test systems. This position can provide a great opportunity to learn, grow, and develop as an employee.

The person hired for the position of Manufacturing Engineer will provide technical leadership and manufacturing support within the Plastic Molding and Assembly Plant. This position will be supporting development and deploying of new or improved process technology, new product development, cost reduction and quality improvements. In this position, the person is responsible for driving operational excellence within the areas of support and is expected to initiate and conduct broadly defined technical tasks within the process technology platforms. They are also responsible for advising, consulting and troubleshooting area processes within the plant.

The person hired for the position of Manufacturing Engineer will support the Personal Care Division in the IATD business as a part of the Film Manufacturing & Supply Chain Organization (FMSCO) from within the 3M Menomonie Facility. The person will be part of a team supporting the personal care business in producing hook products for multiple customers throughout the world.

The person hired for the position of Quality Engineer / Technologist will work and interact with other cross functional team members (lab, plant manufacturing, manufacturing technology, regulatory, quality systems, etc.) on quality assurance of our test systems. This position can provide a great opportunity to learn, grow, and develop as an employee.

The position requires being technically competent in the field of monoclonal antibody production. The individual will carry out monoclonal antibody production by hybridoma technology for our contract research projects and in-house development projects.

We are seeking a high caliber Scientist-Engineer I to execute and administer pre-clinical studies to support Product Development efforts, clinical translation research, and regulatory submissions (FDA [510(K), IDE, PMA] and Foreign Notified Body [Design Dossier, CE Mark filings]). This includes procedural management of electrophysiology and cardiovascular laboratory equipment (such as the EnSite Velocity System, WorkMate Recording System, RF ablation generators, ViewMate Ultrasound System, etc.) and disposable products such as introducers, sheaths, guidewires, trans septal needles, and diagnostic and ablation catheters. It also includes oversight / supervision in anatomical analyses such as necropsy.

We are seeking a high caliber Scientist-Engineer I to execute and administer pre-clinical studies to support Product Development efforts, clinical translation research, and regulatory submissions (FDA [510(K), IDE, PMA] and Foreign Notified Body [Design Dossier, CE Mark filings]). This includes procedural management of electrophysiology and cardiovascular laboratory equipment (such as the EnSite Velocity System, WorkMate Recording System, RF ablation generators, ViewMate Ultrasound System, etc.) and disposable products such as introducers, sheaths, guidewires, trans septal needles, and diagnostic and ablation catheters. It also includes oversight / supervision in anatomical analyses such as necropsy.

This role will be responsible for high throughput RT-PCR utilizing liquid handling robotics, cDNA sequencing and vector construction, amongst other activities.

The Assistant I, Manufacturing is a regular employee in a full-time non-exempt position at Adello Biologics, LLC, in Chicago, IL, this employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. Employee employs aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Must comply with Adello policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.

The Research Associate will work in a small team setting to support Adimab's novel antibody discovery, maturation, and production platform. This role will closely interface with the Protein Analytics, High Throughput Expression, Molecular Sciences, and Computational Biology teams.

Performs quality control processing for Stability Products and Reserve Samples and performs appearance inspections.Completes processing documentation and data entry as required for procedures performed and tests performed at contract laboratories.

The Laboratory Scientist performs and manages tasks that result in accurate and timely method development, validation and sample analysis of chemical and biological entities in biological matrix in a regulated environment utilizing various analytical technologies including mass spectroscopy. Displays versatility and accuracy in performing laboratory duties.

The Research Scientist I / II is expected to demonstrate expertise in both the theoretical and practical aspects of organic chemistry. Principal responsibility is the synthesis, purification, and identification of chemical intermediates and target compounds. A major component in the scientist's performance rating will be based on productivity.

To provide technical leadership to local Global API Analytical Technical Support team and to ensure the timely execution of analytical method transfers, method development and validations, and initial qualification and retesting of analytical reference standards.

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

To provide technical leadership to local Global API Analytical Technical Support team and to ensure the timely execution of analytical method transfers, method development and validations, and initial qualification and retesting of analytical reference standards.

We are seeking qualified Lab Technicians to support our GMP and GMP-Source teams. The Lab Technician will work daily within Aldevron's labs performing tasks associated with Aldevron's GMP and GMP-Source services. The Lab Technician is expected to become familiar with all of Aldevron's products and to be able to perform most tasks associated with the purification of plasmid DNA

This position will be responsible for cell culture process development and material production to support R&D, pre-clinical, and clinical activities. In this role, the candidate will work closely with team members in the Process Development group as welland purification groups to evaluate new clones, develop new processes, and generate material.

The Ideal Candidate will have prior experience as a Medical Technician that involved performing some clinical diagnostic testing & using testing equipment. In this integral role you will perform tests in all areas of the laboratory such as: Chemistry, Hematology, Coagulation, and Urinalysis.

As a Laboratory Generalist you will perform laboratory testing that helps veterinarians diagnose and treat pets across the United States. You will join a fast-paced work environment that encourages teamwork and quality, and offers opportunities for personal growth.

At Assurex The Laboratory Technologist I is responsible for specimen processing, test performance and reporting of test results according to laboratory procedures. This position reports to the Laboratory Manager.

In this role, the successful candidate will support upstream development activities, including execution of mammalian cell culture and microbial fermentation processes, support laboratory management and drive data management initiatives.

The successful candidate will join Avitide and undertake affinity resin manufacturing efforts as an integral role in the expanding manufacturing team. Responsibilities will center upon maintenance of the manufacturing clean room and process equipment used in performing resin activation and conjugation to ensure on-time delivery of our high quality affinity resin solutions. A key aspect of this is that manufacturing is undertaken in a quality environment to ISO9001:2015 standards with an emphasis on continual improvement of the process whilst maintaining consistency of the products. Avitide seeks candidates who are highly self-motivated to learn and can work in a collaborative fashion with other interdisciplinary team members in a fast-paced company that seeks to transform downstream bioprocessing.

Perform analysis to get approvals for innovative as well as generic pharmaceuticals; Perform testing as well as Expert Witnessing for Law firms to support litigation; Re-engineer and improve existing products for new markets and applications.

We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever changing healthcare field while simultaneously and organically exuding Azzur's core values:

This position designs, develops and implements new products, processes, test methods and equipment.

The Regulatory Affairs Specialist is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.

Accountability for all aspects of project execution including line layout engineering, mechanical design, vendor / contractor management, equipment procurement, schedule management, project finances, site management and installation support.

Review individual complaints and associated service data to determine risk level and complete investigation into the "As Determined" problem and cause coding for each complaint.

This position is responsible for Regulatory Reporting, including final reportability determination or reportability review and / or processing Medical Device Reports, FARs, or BPDRs.

Conduct critical biological, chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Baxter manufacturing facilities. Work under minimum supervision.

Responsible for designing, developing, implementing and evaluating optimal, cost-effective projects and technologies. In addition to providing technical support and service to these areas, the incumbent may also perform the following functions: supervising, requisitioning, defining, initiating, specifying, documenting and training.

Support Quality and Production groups by using process and regulatory knowledge combined with a data driven approach to problem solving. Become a subject matter expert in application of statistical tools, measurement systems analysis, and root cause analysis. Take ownership of projects and drive to completion, whether working independently or in a team. Will interact professionally with customers in project management and problem solving activities. Regular, punctual attendance is an essential job function. Ability to speak, read and write English. Ensures compliance with BD quality systems, policies, procedures and practices and all local, state, federal and BD safety regulations, policies and procedures.

Prepare reagents and solutions in accordance with production schedule following GMP and department procedure. Complete all required documentation neatly, accurately, and in accordance with FDA, GMP, and ISO. Maintain lab supplies and equipment to support production. Perform calculations and prepare solutions for use in the manufacture of complex panel formats. Handle materials per GMP, MSDS, and safety regulations. Effectively work in a team setting supporting team and business goals and objectives. Must be able to handle volumes in excess of 10 liters and lift up to 25 pounds. Must be able to work overtime when necessary to meet business requirements. Responsible for own work and accountable for decisions made. Responsible for follow through on responsibilities assigned. Able to function under minimal supervision. Able to successfully complete other tasks as assigned.

The QM Associate Scientist is a laboratory Microbiologist who independently schedules and performs a wide variety of multiple, complex microbiological tests of complex biological raw materials and greater than 100 different complex products in response to customer demand. The QM Associate Scientist performs data analysis using visual, instrumented, graphical and calculative means based on the biochemical, selectivity and growth promoting properties of media, In addition, the QM Associate Scientist assures that documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA / GMP guidelines. The QM Associate Scientist performs non-routine detailed project support and investigational testing and is involved in resolution of technical issues related to microbiological processes. The QM Associate Scientist is subject to extended periods of sitting, and standing, frequent walking, and occasional lifting of materials weighing 25-50 pounds. The QM Associate Scientist must be able to use personal protective equipment (e.g. respirators, gloves, etc.). The QM Associate Scientist must be willing to Cross train in other sections of the Quality Laboratories for surge events and as needed. The QM Associate Scientist must be able to train other personnel on appropriate test methods and techniques thoroughly, as needed. The QM Associate Scientist must exhibit the Becton Dickinson Core Values to do what is right, take personal responsibility,anticipate and address the challenges of patients and customers globally, as well asinnovate and improve continuously, and respect, collaborate, challenge and care about each other.

Verification and Validation of droplet digital biology products, including but not limited to assays, reagents, consumables, instruments and software.

You will work in an assay development team on development of new in vitro diagnostic (IVD) tests for oncology using state-of-the-art droplet digital PCR (ddPCR) technology, in a multi-disciplinary department that includes assay research and development scientists, hardware engineers and software engineers

Work in a team based environment to perform routine Bio-Plex QC assays on raw materials, in process and final products.

The responsibilities of this position are to process retail bottling of antibodies and proteins; capping and labeling of antibodies and proteins. Perform special and bulk bottling for retail customers. Assist with annual inventory. Perform additional duties as assigned.

Communicates with Clinical Project Managers, Clinical Operations Associates and / or Specialists regarding image quality, deliverables, and data discrepancies

The Quality Assurance Specialist facilitates and assists in execution of systems to assure cGMP compliance for all relevant operations carried out within and for BioDuro, LLC.

BioLegend is seeking a highly motivated Quality Control Associate to join our Research and Product Development Team. This position will work under minimal guidance to perform quality control testing in a fast-paced, goal-orientated environment. The responsibilities include, but are not limited to, performing assays using a variety of approaches such as primary cell preparation, cell separation, immunofluorescent staining, and flow cytometry (FACS) data analysis, performing experiments (e.g. cell preparation, cell separation and flow cytometry testing), analysis and reporting of data, maintaining accurate documentation, using internal company databases for product filing and retrieval, and following company SOPs and ISO requirements.

This position is an individual contributor role within the Product Development team and will responsible for performing all essential functions related to antibody purification such as following procedures, optimizing processes, troubleshooting problematic results, performing buffer preparation, pre- and post-purification sample preparation, and database entry. This position is an individual contributor role within the Product Development team and will responsible for performing all essential functions related to antibody purification such as following procedures, optimizing processes, troubleshooting problematic results, performing buffer preparation, pre- and post-purification sample preparation, and database entry. This position is an individual contributor role within the Product Development team and will responsible for performing all essential functions related to antibody purification such as following procedures, optimizing processes, troubleshooting problematic results, performing buffer preparation, pre- and post-purification sample preparation, and database entry.

The Regulatory Affairs Associate will work with BioLegend's existing Quality Team to assist with meeting FDA requirements for class I medical devices, (IVD and ASR), and International In Vitro Diagnostic Medical Devices Directives. The RA Associate is also responsible for ensuring that products and their labeling meet all regulatory requirements (national and international).

The Production Associate will an integral part of BioLegend's Recombinant Protein routing and will be responsible for performing routine cell culture, protein production, and raw material preparation in manufacturing scale and inventory maintenance. This position will also function as a member of the Molecular Cellular Immunology team to assist with intergroup tasks.

The Regulatory Affairs Associate will work with BioLegend's existing Quality Team to assist with meeting FDA requirements for class I medical devices, (IVD and ASR), and International In Vitro Diagnostic Medical Devices Directives. The RA Associate is also responsible for ensuring that products and their labeling meet all regulatory requirements (national and international).

The Manufacturing Associate will be an important member of our Finished Goods Inventory/Bulk Inventory team that supplies purified bulk antibodies for finished goods and custom bulk orders. This position will be responsible for performing all essential functions related to FGI and bulk antibody processing, including verifying specifications and sales order information, reviewing available inventory, adjusting concentration, performing buffer exchange if necessary and endotoxin assays. These materials will support customers in the areas of Immunology, Neuroscience, Cancer, Stem cells, and Cell Biology. This position will also interact with external groups including Planning, Bottling, Customer Service, Marketing and Internal Sales. This is a great opportunity to enhance your knowledge in the biotechnology industry.

The Tissue Culture Associate position will be responsible for handling hybridoma lines in preparation for potential manufacturing activities. Functions will include culturing, subcloning, small-scale and large-scale production runs, banking, performing characterization assays, adaptations of cells to different media and/or conditions, and decontamination of cell lines as needed. All performed work will be documented in lab notebooks, controlled forms, and databases. This position is expected to work independently and in a team environment under established safety guidelines. Communication with various department representatives is expected with emails and meetings.

Support Clinical Trial Manager (CTM) in preparing and/or reviewing study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines).

The new Sr. Associate Scientist will develop and support Next-Generation Sequencing-based assays to evaluate gene-editing based therapeutics for clinical applications. The new hire will also contribute to immunotherapy and hematopoietic stem cell (HSC) platforms.

 The candidate will interface with the internal Quality Control GMP Testing Lab, Process and Analytical Development groups, and Supply Chain for the maintenance and shipping of critical reagents and critical test articles. A strong technical background in cell biology, biochemistry, and/or molecular biology will be utilized in the role. This position may require hands on laboratory.

The ideal candidate will lead target identification effort using internal and external datasets, as well as support scientific computation and bioinformatics effort from early target discovery, optimization to late stage translational medicine investigation. This will be an exciting opportunity to be involved in various stages of the drug discovery process using your computational and analytical skills, and working in an innovative, motivating and collaborative environment.

Executes routine unit operations in Downstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures.     

Executes routine unit operations in Downstream manufacturing as assigned related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures.     

Executes routine unit operations in Cell Culture or Purification as assigned related to the manufacturing of bulk drug substance in a multi-product facility. This may include tank or bioreactor CIP/SIP, cell inoculation and transfer, harvest, chromatography, and tangential flow filtration. Performs duties under limited supervision and according to standard operating and manufacturing procedures.

The Scientist I applies engineering/scientific skills and commitment to quality to execute experiments and complete data analysis in support of projects. This individual will gain knowledge in scientific/engineering concepts, business practices, and core business principles.  Work will be completed in office and Microbiology laboratory settings.

Boston Scientific is seeking a highly motivated and experienced engineer with expertise in new product development to lead the design and commercialization of new cutting edge technology. 

Quality Engineer II who is responsible for the direct support of medical device manufacturing lines, specifically within the Core Tech Polymers production area at the Maple Grove site. This includes driving continuous improvement in product quality and compliance, managing the control of non-conformances, and being a key partner to the Production and Manufacturing Engineering teams.

The R&D Engineer I will develop products, materials, processes, or equipment for complex systems under limited supervision/guidance. You will compile, analyze, and report operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.

Perform weekly site safety/environmental inspections noting potential deficiencies and areas for improvement. Then working with the appropriate parties to identify address the root cause and correct any areas of concern.

The Technician III, Instrumentation & Controls is responsible for supporting Brammer Bio facilities in Cambridge, MA with a scope encompassing building and utility systems for GMP manufacturing, process development, quality control, and warehouse operations. Will perform planned and unplanned calibrations and repairs of instrumentation and laboratory equipment. Will respond to instrumentation and equipment related issues that arise during facility operations. Will create and maintain relationships with other sites to develop and promote best practices. Will uphold, define, and police safety procedures and safe work practices. Will ensure work performed is in compliance with cGMP regulations and Brammer Bio’s SOPs. Will work closely with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities.

This position will work in the GMP compliant QC Laboratories to qualify, and conduct cell-based, nucleic acid-based, protein-based, and chemistry-based assays that support quality control of biopharmaceutical products being developed and manufactured. Will perform routine assays and testing including PCR, real time PCR, agarose gel electrophoresis, SDS-PAGE, immuno blotting, ELISAs, immunocytochemistry, and infectivity and reporter gene based cell assays using insect or mammalian cell lines. Functions also involve maintenance of cell lines used in the QC laboratories, maintenance (routine and preventive operation) of equipment, and preparation and purification of commonly used biological reagent and chemical supplies. The incumbent will be expected to technically interpret, write controlled documents and reports, and review data produced by self and participate in laboratory investigations. Will interact with other departments to ensure that sample flow, supply chain, and equipment disposition are correctly maintained.

This position in Toxicology Operations is crucial for the support of the portfolio by co-ordinating successful conduct of toxicology studies in DSE, NBR. The Biological Technician group is at a critical mass due to the departure of a Biotechnician and not filling this position will critically impact productivity, result in gaps in compliance and portfolio support.

The position serves as the day-to-day owner of the machine processes and process control systems for the plant. Own and manage the development of troubleshooting skills of the manufacturing professionals. Act as a subject matter expert for the machine processes. Participate and/or lead in Continuous Improvement projects. Help to identify and support projects that will improve productivity, waste, quality and safety performance on a long term basis.

Caribou is seeking an experienced Animal Technician to join its R&D team at its facility in the Bay Area.  The candidate must be motivated, enthusiastic, professional and committed to working as a team player.  The ideal candidate enlists confidence, comfort and a working knowledge of laboratory animals, with a background in animal husbandry, restraint and handling.  In addition, experience with injection and blood draw techniques, along with rodent surgery and anesthesia experience is desirable.  The candidate must have the ability to effectively communicate with coworkers, take direction from supervisors, and be accountable for their actions.  They must possess a strong attention to detail and always strive to perform quality work.  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.

The Training & Development Coordinator is responsible for the successful implementation of the site Training Program.  This position ensures the successful coordination of training activities, including scheduling, ordering, ensuring space availability, etc.  This position also assists with the development of course content, and helps to facilitate the new hire onboarding program.

The successful candidate’s primary role in this position will be to ensure batch-to-batch reproducibility between IF-approved materials originating from manufacturing. They will utilize tools such as confocal microscopy and high-throughput imaging to provide internal customers with detailed antibody performance reports.

The Research Associate (RA) will support the Epigenetics team in driving product development, including development of both antibodies and other product types, such as kits. He/she will serve as a resource for the analysis of antibody specificity along the various stages of development, including assessment of antibody utility for immunoprecipitation and western blotting applications. In addition, team members are expected to continuously evaluate leading edge technologies and techniques, and to sponsor their implementation.

Restock and clean lab as needed.Understand basic laboratory concepts and be able to perform basic lab techniques, including routine and preventative maintenance. 

To assist in the development and licensure of viral, bacterial, recombinant and/or parasitic vaccines as well as new label claims or product improvement research of the licensed vaccines.

Perform basic laboratory tasks and banking in support of in vivo oncology studies in mice. Maintain and collect data using various systems. Manage studies and perform more advanced technical manipulations such as IV administration. Serve as a mentor for more junior staff.

Support research studies by providing the highest standard of humane treatment and care of all animals housed within our animal care and use program.

Under general supervision, responsible for providing, coordinating, documenting and scheduling orientation and routine to moderately complex training activities. Also responsible for developing, revising, and implementing the use of training documents including SOPs and processes to support the overall training program.

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.

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.

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

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

The successful candidate will be responsible for manufacturing DNA Nanoballs as required by R&D, prepare libraries, formulate and assess a variety of reagents, run different biochemistry experiments, operate sequencing instruments, manage data, troubleshoot, and analyze data using various proprietary and nonproprietary tools.                                       

The successful candidate will support and develop automation solutions related to the genetic engineering and screening of industrial microbes.

The Quality Engineer New Product Development (NPD) is responsible for supporting all quality engineering activities to support the new product life cycle, from concept through commercialization and sustaining changes, as part of a cross-functional development team.  Serves as the key resource for ensuring compliance to ISO, MDD and QSR requirements for Medical Devices. Takes the lead with quality initiatives with inter-organizational impact following QSR, ConMed Policies and standards. Works under direction from Quality Management.

Adherence to all company procedures. Perform sampling of in-process and raw materials. Release of materials. Manage the retain program. Perform weekly cycle audits. Check in-process work. Oversight of environmental monitoring and water systems. Perform cleaning verifications.

Applying viscoelastic fundamental theories to understand the stress relaxation and structural relaxation material behavior during glass forming/reforming processes

The candidate will be responsible for delivering high impact in the organization by developing enabling software systems for the Research, Development, and Engineering divisions at Corning.  Delivering software solutions will be accomplished through the evolution of innovative concepts across early stage experimentation, proof-of-concept demonstrations, and prototypes.  The role requires a multidisciplinary approach including mechanical engineering, controls and software development, and scientific leadership.  The candidate should feel comfortable working within and communicating among a small team of individuals with diverse talents.

This position of Research Associate, Optical Physics is in the Micro and Nano Optics (MNO) department of the Science and Technology Division of Corning. MNO combines deep understanding of display and telecommunication systems with fundamental research in structured materials to develop new advantaged optical products. We seek out scientists with experience in optics and materials. The candidate should have a track record of combining experimental results and fundamental understanding to yield new insights about the interaction of optical fields with surface and volumetric structures within glass and ceramics. Our projects are fast-paced, and we expect our scientists to rapidly build up new experimental and modeling capabilities as the need arises. We constantly add to our experimental capabilities, which today include the full range of display system measurements, scattering measurements, waveguide measurements, and various linear and nonlinear spectroscopies. Our product design length scales go from tens of nanometers to tenths of millimeters --- requiring scientists knowledgeable in the variety of modeling techniques required to understand how features of these sizes impact material performance.

Controls Engineer will analyze user requirements, process design, and mechanical equipment design to create controls architecture for automated systems.

Improving processes and solving problems based on fundamental understanding gained through the use of the scientific method

As an Intake Associate you will be a member of a team responsible for the timely and accurate data entry and management of our paper requisitions. You will be a significant contributor to our high-throughput workflow and an integral part of our busy CLIA lab.

Accurately perform blood pressure, pulse, weights, respiratory rate and temperature readings

The Regulatory Affairs Specialist works directly with the Regulatory Affairs Managers and/or Director to assist with regulatory submissions, primarily Tier II country submissions. In addition, the RA Specialist will provide support for country and state licensing activities and assist with responses to the FDA and other regulatory agencies as needed.

Perform real time documentation (batch record, logbook, etc.) review concurrent with manufacturing operations on the manufacturing floor.

Responsible for performing research and laboratory tasks for projects and products in collaboration with internal, external, and global R and D peers.

Performs deviation investigations for manufacturing using site procedures to ensure root cause is identified and appropriate corrective actions are put in place within 30 business days.

The successful candidate will actively participate in experimental design, performing experiments, and troubleshooting, as well as performing data analysis and interpretation. The ideal candidate will be independent, self-motivated, collaborative and able to multitask effectively while frequently under pressure to meet tight deadlines. 

Under guidance and detailed instructions, plans, designs, tests, and develops mechanical systems, parts, equipments and packaging. Applies basic knowledge of engineering principles to design simple components and assemblies. Conducts engineering analysis and testing on designs using existing designs and tools. Participates in concept and design reviews and activities. Ensures design requirements and standards are met. Compiles mechanical design documentation and approvals. 90% of time is spent in a resource capacity. 10% of responsibilities are in leadership activities.

Conduct the controlled substance inventory audits for manufacturing, analytical, import & export registrations.

The purpose of this position is to help advance Dynavax’s immuno-oncology discovery research to inform clinical progression of our programs

The successful candidate will contribute as part of a multidisciplinary team to improve gene-editing based therapeutics by developing techniques and researching new understandings in RNA folding and engineering. The successful candidate is expected to have proven practical experience in creating and analyzing next-generation sequencing data sets from mammalian cell culture experiments using cutting edge molecular biology techniques. RNA and cell culture experience in immortalized cell lines is expected. The candidate should be a scientifically motivated self-started, capable of independently conceiving, conducting, and critically analyzing his/her own innovative research with minimal supervision. Strong presentation skills, communication, and the ability to work in a fast-paced and team-oriented environment will also be vital.

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Please refer to the job description for additional details.

Recombinant mammalian protein expression, including target design, transfection, HEK and CHO tissue culture, purification and characterization

Author laboratory investigations using independent thought and collaboration and initiate Non-Conformance Events reports;Identifies and supports change and continuous improvement using LEAN practices such as 5S and Kaizen.

The Analyst II, QC Microbiology position supports the Quality Control group at Emergent BioSolutions Camden Campus to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the Microbiology, Environmental Monitoring, and Utility testing programs, which includes microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives.  The individual routinely conducts monitoring, testing, and SOP generation and revision.

Provide support in research and development efforts for novel analytical models combining multi-modal physiological data

Develop, qualify and validate analytical test methods for drug product, intermediates and excipients;Design and execute analytical development studies.

Routine testing to support analytical laboratory;Using multiple analytical methods including HPLC, Spectrophotometer, analytics, pH, raw materials.

Performing Second Scientist Review of notebooks;Keeping inventory and ordering reagents/supplies.

Support of the design and development of solid oral dosage forms and associated manufacturing processes to enable the successful development of formulations

Responsible for performing routine QC Stability testing of all active substances, excipients, finished dosage forms and complaint samples.

Perform biochemical testing on proteins and antibodies including, but not limited to, CE, IC, HPLC, SEC, SDS-PAGE, UV, Protein A titer, ELISA and/or Bioassays

Supporting cell-based bioassays and binding assays for biological characterization and testing of biopharmaceutical products

Responsibilities will include providing technical service and product introduction to new and existing customers, identifying new customer project opportunities and participation in Polyurethane industry activities to understand the insulation market segment trends and technology drivers.

The Medical Laboratory Technician (MLT) will work in Automated Chemistry area and performs moderate complexity testing. Performs and document quality control and preventive maintenance. Follow good laboratory practices and procedures for compliance.

The Compounding Chemist will be responsible for assisting with the compounding activities of manufacturing solutions and suspensions: weighing, adding and mixing raw materials, sterile filtration, steam sterilization, sanitization, and documentation activities associated with the production of drug products. This position supports the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the U.S. Food and Drug Administration.

Research Technician I, with guidance from the Research Operations Core Manager, will perform Core Lab Methods to support data generation across all research programs.

The Product Development Scientist will play an active role in interdisciplinary teams with an overall goal to provide high-quality mass cytometry reagents. The individual will support the execution of new product introduction and sustaining projects. Duties include tasks to support product scale-up, process optimization, technology transfer and process validation.

Perform routine testing of in-process and finished product samples. Monitor environmental conditions in the production and lab areas. Summarize environmental monitoring and product test results. Provide project support to Scientist and Lead Scientist. Prepare media and reagents and equipment.

The Quality Control Environmental Monitoring Technician is responsible for day-to-day activities required to perform monitoring of aseptic areas and controlled environments.

This individual holding the position of QC Technician II shall be responsible for performing routine testing of in-process and finished product samples, raw material, stability, and utilities.  They shall be responsible for monitoring the environmental conditions in the laboratory and in manufacturing areas.  They shall support validation projects.  This position must be available to work overtime as assigned.

Reports to QC Chemistry Supervisor;Individual must use judgment to determine when independent action is appropriate or to contact supervisor for direction..

Performs routine sample analysis and a variety of tasks to support product development, ensuring agreed timelines

Scientist / Bioanalytical Services Essential Functions Run sensitive, reliable and efficient LC-MS/MS bioanalytical assays for TK/PK assessment.

The Downstream Manufacturing Technician III will work directly with a range of purification technologies including: filtration technologies (TFF and depth), chromatographic separations (Single Use GE AKTA systems), viral inactivation following aseptic techniques and procedures in a cGMP environment.

Responds to service calls to evaluate, diagnose, and perform repair and planned maintenance (PM) on customers’ basic biomedical equipment. Drives customer satisfaction through service excellence.

This position is responsible for evaluating the manufacturing processes to determine root cause and effect of product non-conformities, improve processes to ensure quality, products and services to adherence of quality standards.

 The Quality Control Laboratory Technician role is responsible for sample management, quality inspection and manufacturing support.

Setting-up and operating inspection and/or manufacturing tools/equipment such as conventional electrical discharge machines, grinders, precision assembly devices, peen, heat treat, plasma spray, etc.• Performing basic mathematical calculations•Using precision gages/fixtures and inspection measuring equipment and interpreting mechanical blueprints, sketches, engineering specifications and drawings, etc., to determine set-ups and operations necessary to complete job tasks. •Training duties.• Performing related environmental, health, safety, maintenance, quality, continuous improvement, and production-flow job duties to support plant machinery, equipment, and manufacturing-related initiatives and programs. •Maintaining detailed job task documentation, reports, and records.

A GeneDx DNA Sequencing Lab 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 MicroArray Lab 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 Cytogenetics Lab Technician performs a higher than entry level role in clinical cytogenetic analysis 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.

Prepare amplified template libraries for high-throughput sequencing;Carry out DNA sequencing on next-generation DNA analyzers.

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.

Works with staff from other functional areas to meet complex project deliverables such as new product launches or start-up of new manufacturing/packaging sites.

Glassware washing, storing, and ordering.Autoclaving glassware and prepping for sterile use.Autoclave validation testing.

Assists in all Upstream Development/Manufacturing activities including; cell culture, cell banking, media optimization, seed train design, feed strategy, bioreactor parameter optimization, harvest clarification, and technology transfer to manufacturing.

The Research Associate will be an integral part of the Research Department. The successful candidate will be expected to perform research studies and prepare scientific reports to support pre-IND and IND activities.

Responsible for ensuring compliance with applicable domestic and international standards and regulations through audits and systematic maintenance of effective quality systems.  Ensures that deadlines are met on time and within budget.  Limited interface with other departments and business or marketing partners. Work independently with supervision and exercise judgment within the defined procedures and practices to determine appropriate actions.  

The Label Verification Technician's primary responsibility is to perform a variety of tasks (i.e. operate labeler machine, inspect labels for accuracy, etc.) related to the labeling of packaged biological products.

You will implement and support projects and systems within the site Automation Strategy and provide Automation support (Pharmaceutical Fill/Finish/Packaging) to the Zebulon site within a multi-disciplinary and extended team of Automation, Instrumentation, IT, Control engineers, external contractors and consultants.   Successfully deliver compliant (financial, regulatory (e.g. cGMPs), GAMP) instrumentation, automation, business and control systems for new and existing pharmaceutical facilities, Building Management Systems and Environmental Monitoring Systems at Zebulon.

As a Research Associate supporting product and technology development, you will work with members within the team and interface with multiple teams including process engineering, clinical operations, research operations, IVD team members, and bioinformatics. You will be hands on in the lab and be required to design, implement, and validate new technologies related to liquid biopsy sequencing assays for the early detection, treatment, and monitoring of all cancer types. 

Work as a team to perform complex in vivo experiments utilizing tumor models (syngeneic, xenograft tumor models and humanized mouse models) in both immunocompetent and immunocompromised mice.

Work as a team to perform complex in vivo experiments utilizing tumor models (syngeneic, xenograft tumor models and humanized mouse models) in both immunocompetent and immunocompromised mice.

Work as a team to perform complex in vivo experiments utilizing tumor models (syngeneic, xenograft tumor models and humanized mouse models) in both immunocompetent and immunocompromised mice.

We are seeking an In-House Clinical Research Associate (IHCRA) in our Durham Headquarters to remotely manage and support site activities for the delivery of clinical studies in accordance with the Task Order, protocol, standard operating procedures, ICH guidelines and all applicable regulatory requirements. 

The Quality Control Peer Reviewer performs all activities within Quality Control in compliance with Corporate Operating Procedures (COP), Standard Operating Procedures (SOP), Internal Operating Procedures (IOP), and Federal Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Occupational Safety and Health Administration (OSHA), and Environmental Protection Agency (EPA) requirements. They will also perform QC peer reviewing on all relevant records and analytical data in accordance with Operating Procedures (COP), Standard Operating Procedures (SOP), and Internal Operating Procedures (IOP). They will carry out the analytical review of QC analyses, LIMS authorization of analytical tests and QC release of raw materials, in-process controls, packaging materials, intermediates, and environmental tests.

We support our CRAs with manageable sites & protocols, a strong benefits package that includes a comprehensive health plan, retirement plans, competitive pay, vacation, and eligible for the annual performance bonus. Additionally, we have cutting edge technology to ensure better outcomes.

This individual will play a key role in validating drug targets and running cellular assays using siRNA and small-molecule drug candidates.

Perform the functions and related tasks of antigen (native and recombinant) and monoclonal antibody production and other cell culture activities.

We are seeking a Pharmaceutical Manufacturing Technologist to be responsible for the manufacturing of clinical products in compliance with current Good Manufacturing Practice (cGMP) and Standard Operating Procedures (SOPs).

The research associate will work alongside a team to provide for daily R&D needs while also qualifying reagents under development.  A successful candidate will enjoy working in a fast-paced environment and exhibit excellent interpersonal skills, the flexibility to adapt to changing priorities, and a firm scientific foundation to understand ongoing diagnostic R&D and associated studies.

The Associate will support projects assigned to GRO submission staff across functional departments based on business needs across NA. The primary focus of this position will be to support North American and specific regions in the Australasia markets. 

The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.

Yeast transformations;Molecular biology;Work in partnership with team members to support their needs;Develop and improve workflows, including developing and implementing automation where appropriate. Operate with a sense of urgency.

Perform in vivo assays and other bioassays in mice for validation of potential drug development targets and to characterize pharmacological compounds.

As the Clinical Trials Coordinator, you will work as an integral member of Jazz Pharmaceuticals’ Clinical Operations Team, providing administrative support of our clinical trials. You will work on all phases of clinical trials that are in the JPI product development pipeline. 

The primary focus of the QC Associate I/II role will be to perform GMP testing and environmental monitoring to support lot release and in-process testing. 

The primary focus of this role will be to purify and analyze recombinant proteins. Successful candidates will demonstrate understanding of basic biochemistry principals and working knowledge of protein purification and analysis. Demonstrated ability to follow protein purification protocols and deliver reagents under specified timelines is required. 

This individual will join an innovative, interdisciplinary team focused on the advancement of current analytical methods and maintaining a state-of-the-art flow cytometry facility. This individual will also be required to support colleagues in a cross-functional environment through the performance of routine analytical testing.

The Facility Engineer will ensure that all safety standards are followed. Maintenance and inspections will be done to guarantee that cGMP standard are being followed. Performs routine inspections of the equipment and . Monitoring of the BMS system and coordinating the PM schedule and maintenance activity.

Perform analytical testing of raw materials, in-process materials, stability samples, finished products and product development products using different analytical techniques.

Executes the activities of QC Microbiology Laboratory by following approved microbiological and chemical test procedures and ensure their delivery in an accurate and timely manner following proper safety precautions. Also provide QC microbiology support to the Aseptic Manufacturing and validation process.

Engage with current / future vendors and residents to enhance our mission; Employ your life sciences knowledge to assist residents with the ordering process; Work with Purchasing Lead to provide ordering support across multiple sites .

The Data Coordinator is responsible for supporting EDS data quality via digital form mapping and validation, assisting EDS team members with data quality issues handling, and supporting the Data Manager with special projects related to data quality. All activities ensure quality deliverables on time to EDS clients.

Assigns, oversees, and reviews the work of employees. Directs all phases of work, quality, service, and costs; and performs tests or assays as required.

Provides leadership in the areas of quality assurance, quality control, quality related training, and standardization compliance within the laboratory. This position is also responsible for project management activities as they relate to identified areas within the laboratory requiring standardization to improve the quality and/or efficiency of operations.

Assigns, oversees, and reviews the work of employees during assigned work hours; Directs all phases of work, quality, service, and costs;Performs tests or assays as required.

We are is seeking an enter level Technologist to join our Mass Spectrometry team in Burlington, NC! Assays performed in our department utilize a variety of scientific techniques, including Performs tests and analyses according to established procedures in designated technical department. Position may perform various techniques including EIA, IFA, and other non-automated and automated procedures.

Receive specimens for testing; evaluate specimens and test orders; determine priority of work and batches to maintain acceptable turn-around-time; recognize unacceptable and unusual specimens and handle appropriately.

The candidate will provide support to the Process Development group. 

Perform Cell-based and Enzyme-based assays and related procedures using manual and automated liquid handling equipment

To collect, process and package various abattoir sourced animal blood and/or tissues at the Coopersburg Lab and/or off-site abattoir/vendor locations as need to support production requirements.

The successful candidate will be responsible for learning, researching and implementing recombinant DNA approaches to support research team needs, as well as designing work-flows, and assay development.

Purification of normal, secondary antibodies, and custom mono and polyclonal antibodies with the goal of providing consistent, high quality products and services to our customers with complete, accurate documentation.

The Junior Engineer will support ground transportation-related work for contracts with the U.S. Department of Transportation (U.S. DOT), State Departments of Transportation (DOTs), and the National Highway Traffic Safety Administration (NHTSA). 

rovide subject matter expertise in workgroups for replacement of customer systems Interface e.g. (Sensaphone, Computerized Maintenance Management System, and Ventilators) and perform as the strategic liaison with the appointed representative within Program for the development of the management tool for the accountability of Maintenance tools and systems.  Provide research and analysis with vendors, site personnel, customer IT Support, customer Quality Control Unit, customer Team Room, and customer Leadership that manages the Chemical Package program.

The selectee will, under the leadership of Senior Personnel, provide technical expertise to aid the Government in the overall certification of cryptographic products for ground/airborne/satellite communications including those making up Space Systems of Systems, a collection of task-oriented or dedicated systems creating more security functionality than the individual components

Independently develop protocols, applications, and products. Identify product opportunities consistent with corporate goals. Independently plan and execute experiments, and review results with supervisor. Write reports, technical documents, and application notes. Develop synthetic routes and analytical methods. Perform syntheses and purifications at bench scale (milligram to kilogram) of chemical products for Research and Development, clinical trials and commercial use. Analyze compounds produced and maintain documentation of experimental results. Prepare and present scientific posters at national meetings. Mentor others in the group. Keep laboratory notebooks, attend project and group meetings, and perform other job-related duties as required.

We are seeking individuals who are passionate about research, bring out of the box thinking and take bold steps to develop innovative technologies with applications in the ubiquitin research field.

The Scientist I position will perform a variety of tasks in support of all Process Development activities.

Manage, coordinate, and maintain CGMP documentation, procedures, and records to ensure only controlled copies are reviewed, approved, issued, distributed, and archived.

The Manufacturing Assembly Associate II is responsible for the building of plastic parts into a medical device cassette for use by Engineering R&D, Clinical Studies and Product Sales. The  process of building may be done manually with simple tools, fixtures and/or automated equipment. Any process control points will be processed similarly to the build process. Additionally, this position involves the maintenance and/or calibration of equipment used for the manufacturing of product under the company quality system. 

This is an individual contributor position responsible for assisting in the management of adverse event reports. The incumbent in this role will support pharmacovigilance activities including but not limited to: adverse event data entry into the safety database; reconciliation of the safety database with clinical databases, exchanging safety information with business partners and other vendors; and providing general administrative support.

Successful candidates will participate in and develop competencies in a wide variety of techniques in the fields of cell and molecular biology, biochemistry and immunology and will be able to develop independence to manage multiple projects. Additionally, successful candidates demonstrate collaborative and professional skills used in client services.

Key individual contributor in the development of next generation sensors/tools and improvement in existing products/tools;

 The successful applicant will become a core member of a highly interactive team of senior and junior scientists who bring with them an expertise in lipid biology, drug-discovery, pharmacology, assay development, liver lipid biology, and mouse models of liver disease.

The main duties for the ideal candidate are to help build gene- and stem cell-based approaches to support MedImmune’s pipeline projects. This candidate will be responsible for optimizing and testing viral vectors for transduction efficiency, sustainability, safety and manufacturability. You will also be responsible for maintenance and differentiation of pluripotent stem cells. You will plan and execute experiments on the bench. In addition, you will be working in a multidisciplinary matrix environment to design strategies towards clinically relevant strategies.

Develop and characterize downstream processes for the manufacture of biopharmaceuticals (monoclonal antibodies and other proteins) in late stage clinical development through commercial launch.

Test API and final drug substance and drug product according to written procedures following cGMP practices

Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol

The Medical Writer [Bilingual - Chinese (Cantonese/Mandarin) and English] role in our Medical Affairs organization supports the Global Neurovascular business unit. The bilingual (Chinese/English) Medical Writer will be focused on developing clinical, scientific, and regulatory documents for the China FDA along with some responsibilities for other global markets.

In this exciting role Supplier Quality Engineer, you will have responsibility for supplier management activity working with external suppliers and internal teams to assure that our products exceed the requirements and expectations of patients, physicians, regulatory agencies and the business.

Serve as Clinical Affairs representative on assigned project teams and/or PDP teams to develop clinical strategies that support corporate and departmental objectives. Provide clinical and technical feedback to product development teams during project team meetings. 

This position will be responsible for developing test methodology to conduct material, component and device level testing to ensure products meet specifications and regulatory requirements. The engineer will conduct verification and validation activities inclusive of creating protocols, testing per approved protocols, and documentation activities in accordance with applicable development and regulatory requirements. The engineer will collaborate with design colleagues to ensure designs are capable of meeting performance targets while supporting multiple projects within the product development group.

 Coordinate activities related to safety assessment, report management, safety committees, system and process development, policy review and implementation, and management review.  Contribute to accurate and timely reports for study teams and management, including resolution of action items.  Maintain documentation consistent with Medtronic standards, guidelines and policies. Execute continuous improvement projects, perform other duties and ad hoc projects as assigned in support of the Clinical Research department.  

A Research Associate I (RA I) is responsible for carrying out reagent and assay development activities in the laboratory, under supervision, working to achieve development project goals including data analysis and assay qualification. This is a laboratory position performing protein-based immunoassays on a routine basis with relatively high throughput (3-10 plates per day).  Some degree of professional latitude, creativity and self management is expected.

Manufacture or evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department.

To perform routine and non-routine chemical analysis, following established protocols and procedures; to accurately interpret results and to prepare complete and legible records; to provide lab support and to maintain equipment.

Analyze products according to established protocols, provide technical support to others and perform operations in support of the group and department.

The purpose of this position is to contribute to the overall success of our drug discovery pipeline by helping perform purification of small molecules and several physicochemical assays.

Analyze products according to established protocols, provide technical support to others and perform operations in support of the group and department.

Primary responsibilities will focus on conducting thermal analyses and calorimetry experiments to address safety needs for bulk manufacturing in large-scale plant equipment. Other responsibilities will include generating technical reports and executing preventative maintenance on equipment.

As a member of the Miltenyi Biotec Regulatory Affairs Team, you will be responsible to support all company regulatory objectives to ensure that products meet worldwide regulatory requirements on all aspects of product approval and post-marketing compliance. In addition, you will act as a regulatory liaison for medical and clinical research groups to keep the regulatory affairs department apprised of research progress. Overall, you will be a key contributor to the continued success of all submissions to North American regulatory agencies.

The successful candidate will primarily work with in vivo tumor models and be responsible for validating the in vivo pharmacology and therapeutic utility of novel mRNA therapeutics.  Applicants should be great team members and have a track record of independent research accomplishments.

The primary responsibilities for the Research Associate, Process Development will be to support the Process Development team to develop and scale-up messenger RNA therapeutics. The scientist/engineer will be involved in clinical study enabling scale-up and pilot production of mRNA. The position will partner closely with Process Sciences and Production teams, and the candidate must be able to work in a multi-disciplinary environment.

Reporting to the Senior Manager of Quality Control, the Quality Control Stability Associate will be responsible for supporting GMP stability testing programs and Quality Systems, including the maintaining of stability databases, performing data trending and statistical analyses, creation and review of SOP’s, stability protocols and reports in accordance with current GMP, FDA, EU and ICH guidelines and regulations. This individual will also support the implementation and functionality of stability related processes, equipment and systems at both the Cambridge, MA and Norwood, MA locations.

The individual in this role will be part of a cohesive team responsible for producing high quality mRNA-based medicines for evaluation in human clinical trials.  The Manufacturing Support Specialist team member uses knowledge of cGMP regulations and biopharmaceutical production processes to assist in investigations, document generation and improvement initiatives within manufacturing operations or other departments as needed. They will work directly with subject matter experts to ensure content accuracy, improve efficiency and documentation practices.

This position is part of Moderna’s Manufacturing Science and Technology (MST) team responsible for ensuring the robust technology transfer and technical support of our mRNA platform in cGMP Manufacturing.  The individual will work closely within MST, and with Process Development, Manufacturing, Regulatory, and Quality, to ensure all aspects of technology transfer and technical support are successfully executed.

This position is responsible for following established methods to quantify chemical entities according to applicable Standard Operating Procedures (SOPs) and/or GxP regulations. This individual proficiency in the use of instrumentation and laboratory techniques. This individual contributes to the department by completing assigned projects on time, participating in process improvement communicating effectively with others. initiatives, and demonstrates

This position is responsible for performing the technical functions in necropsy including the handling and euthanize of multiple species of animals, collection of tissue and blood samples, and the proper preservations of specimens, as well as for performing technical support functions, as necessary. It is expected to perform assigned technical and administrative functions within the guidelines / requirements outlined in a protocol or Standard Operating Procedure (SOP), thus producing sound, reliable data from which to evaluate the efficacy or toxicity of a test compound.

This position is responsible for performing assigned basic support functions in the Clinical Pathology Laboratory setting. Functions include Set-up, Processing, Sample Management, and/or administrative functions as outlined in a protocol or appropriate Standard Operating Procedures (SOPs).

The successful candidate will join a team of researchers actively conducting genomics-based research in infectious disease diagnostics, bio-surveillance, microbiology, virology, and microbial forensics for a variety of government and industrial clients.

Work with pharmacology colleagues to gain an understanding of primary and secondary pharmacology mechanisms, biomarkers, translational potential, and safety for discovery- and development-stage programs

Creates, evaluates and completes International regulatory projects consistent with the company goals. Successful candidate is responsible for assembling regulatory submissions and international dossiers to non-EU territories. 

The Manufacturing Research Associate I is responsible for supporting the production of reagents used in nCounter Analysis Systems. The role requires learning and performing both manual and automated production processes for the manufacture of raw, intermediate, and final reagents needed for the multiplexed detection and quantification of many different types of target molecules from biological samples.

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.

Clinical Laboratory Associate I to analyze laboratory specimens following the standard methods and procedures while maintaining equipment and instruments in good operating condition by troubleshooting malfunctions as needed.

We are seeking highly motivated, energetic and committed individuals to join our interdisciplinary team and actively contribute to advancing our drug discovery programs from discovery to proof- of-concept. You will build your experience in early discovery projects using cell-based and biochemical/biophysical approaches to support small-molecule discovery activities and advance our cutting-edge programs that target the mTORC1 pathway.

Perform molecular biology assays such as PCR, HRMA, Restriction Enzyme digestion, and gel electrophoresis.

You will be reporting to the Molecular Biology Supervisor working among a team, to deliver custom transgenics to our clients, in a timely manner, using established procedures.  The sophisticated nature of the work requires attention to detail and high-functioning knowledge of current molecular biology techniques.  The ability to work independently according to schedule is balanced with the need to collaborate extensively with colleagues to ensure that we consistently meet or exceed our clients’ expectations.

You will be reporting to the Molecular Biology Supervisor working among a team, to deliver custom transgenics to our clients, in a timely manner, using established procedures.  The sophisticated nature of the work requires attention to detail and high-functioning knowledge of current molecular biology techniques.  The ability to work independently according to schedule is balanced with the need to collaborate extensively with colleagues to ensure that we consistently meet or exceed our clients’ expectations.

The main responsibility will be to setup a quality control program and testing for products and materials. Other responsibilities include but are not limited to, calculating and summarizing data using scientific equations, set up and perform studies on components, record test results on standardized forms and write reports detailing procedures, file and maintain retention storage of all product components and reagents.

Lateral Flow Chemist

Perform microbiology department related tests according to USP methods and established procedures that follow cGMP guidelines and demonstrate outstanding aseptic techniques.

This is a highly dynamic role with responsibility to support programs across NGM’s research and development portfolio. 

Responsibilities include implementing regulatory plans, completing regulatory deliverables for medical devices and supporting customers with product registrations.  

Collaborate with R & D, Regulatory and Global Graphics Designers to create labeling for medical products. 

Responsible for completing product attribute and particulate inspections, manufacturing batch record review, line audits, and product sampling to ensure products are manufactured in compliance with corporate, regulatory and industry standards. Functions as primary contact for QA operations team, escalating issues to supervisors as needed. Participates in development and implementation of quality projects and supports department initiatives.

The Associate Systems Engineer, Systems Design Verification, will be integral in the technical design and development of Insulet’s products by supporting all phases of the Design Verification Process.  The person in this position will be required to design, execute and report on engineering tests, for characterization and Design Verification, as well as participate in the documentation and resolution of product development issues.  This role requires a strong engineering background with the ability to fully understand Design Verification principles.

Responsible for formulation and process development activities associated with parenteral drug product development. Participates in scale-up of manufacturing process.

The primary responsibilities of this role are the execution of equipment and process improvement projects, to contribute to the design, development or enhancement of new and existing products and processes and being a system owner for manufacturing equipment and processes. Enhancing process knowledge and technical problem solving are major elements of this position. This positon will provide technical support to the manufacturing and maintenance functions for the operation of equipment and processes.

Responsible for manufacturing assigned products/product lines by following established manufacturing procedures

Coordinate and assist in performance of installation, calibration, maintenance, and IQ / OQ / PQ activities for GxP and non-GxP analytical equipment.

The Specialist position supports the global Strategic Sourcing and Vendor Management function of Pharmaceutical Sciences through timely preparation, negotiation and execution of various contracts and other outsourcing-related documents.

Responsible for executing basic / routine experiments under supervision. This position also assists in the planning of basic experiments and experiments and performs specialized / complex experiments with assistance from supervisor as appropriate

In this role you will be developing pharmaceutical formulation of solid orals and / or parenterals. You will be developing and evaluating dosage forms such as powder flow, granulation, compaction, disintegration, dissolution and stability.

The CRA will report to the Associate Director of Clinical and Regulatory Operations and is responsible for assisting with the design, administration, and monitoring of clinical trials; monitoring and managing clinical data from collection through locked database; and ensuring compliance with clinical protocols, their objectives, and ICH and GCP guidelines.

The qualified candidate will assist with and / or individually carry out chromatographic purifications, various filtration operations, formulation studies for Voyager s various rAAV products, and conduct stability studies. Work activities will also include following / preparing protocols, SOPs and final study reports, and general lab operations.

The Document Control Specialist's primary responsibilities will include QA documentation and record keeping, QA raw material control, quality systems (documentation control, failure investigation, deviation reporting, etc.) and training documentation. They will also provide backup support for external audits.

This position is responsible for processing samples for assigned tests in compliance with GLP, GMP and ISO standards.

Performs assays according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and / or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Completes batch records and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and / or PTC guidelines and SOPs. Performs additional Research & Development activities as required. Performs daily work activities with minimal supervision.

Performs various mathematical calculations including subtraction, addition, multiplication, division, and statistical analysis including means, standard deviations, coefficient of variation (% std dev), percent change, percent difference, etc.

Manage international regulatory compliance activities for Charles City Operations with emphasis on providing documentation to support new registrations, renewals and process changes of veterinary biological products produced in Charles City

Under the direction of the Chief Scientific Officer, you will assist in the conduct of research and preclinical studies involving adult human stem cells. This includes planning, conducting and directing a variety of experiments and assisting in daily activities for research projects. 

The Specialist, Regulatory Affairs is responsible for obtaining regulatory approvals in U.S. and ensures compliance to agency requirements including ISO, local, state and/or federal requirements

The Industrial Engineer I will support the manufacturing of products for medical devices with work including Operational systems development, process flow, Operational needs and Process efficiencies.