- Determination of critical process parameters, and developing robust, industrial processes for cell culture production of protein derived from mammalian cell lines for cGMP implementation
- Experience with and cell culture scale up/down and process characterization
- Experience delivering material suitable for toxicology studies to support regulatory filings
- Leading development, hands-on execution, and optimization of protein expression including cell culture from microplate to , familiarity with cell banking, comprehension of manufacturing processes (specifically batch and fed-batch) and harvest of material at required scales.
- Leading scale-up and tech transfer of protein expression processes for external manufacturing under various regulatory systems (e.g. ISO13485, cGMP).
- Executing, adapting, and troubleshooting analytical methods for protein characterization, including cell based assays
- Data analysis and authoring key documents such as development reports and technology transfer packages.
- Representing the Bioprocess Development team in cross-functional project teams and communicating data, results, and conclusions to scientists, project management, business development, and other stakeholders.
- Ensure a continuous improvement within Upstream process development activities
- Technical leader for equipment, technologies for Upstream process development
- Execute routine scale down protein expression using benchtop bioreactors to optimize protein expression processes
- Provide expertise and insight to guide development of appropriate expression methods
- Perform, develop and optimize robust, efficient, scalable strategies for improving process performance
- Activities will include small-scale studies and pilot scale expression studies
- Apply DOE methods to expression activities
- Mentoring junior Associates or Co-Ops and helping them in their planning and activities.
- Understand and keep current on key areas of science and technology, anticipate changes and new directions in the field
- B.S. (Graduate degree preferred MS and PhD) in Biology, Biochemistry, Biomedical Engineering, or an equivalent engineering/science degree with 6+ years of experience working in the biopharma industry
- Strong hands-on experience in troubleshooting and routine instrument maintenance
- Upstream processes at the small to an intermediate scale of cGMP biologics production.
- Process scaling and/or technology transfer.
- Authoring and executing protocols, interpretation of data, and report generation.
- Operating and troubleshooting process equipment.
- Ability to work independently and as part of a cross-functional team
- Ability to adapt to frequent change and thrive in a dynamic early-stage environment
- Strong communication and organization skills, strong knowledge of MS Office, data plotting and graphing software. Must be able to communicate results effectively. Experience using electronic lab notebooks preferred.
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Scientist - Process Development
2 weeks ago
Thermo Fisher Scientific Cambridge, United StatesThermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner. · Within our Anal ...
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Process Development Scientist
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Amgen Cambridge, United States**HOW MIGHT YOU DEFY IMAGINATION?** · You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission—to serve patient ...
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Process Development Associate Scientist
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Amgen Cambridge, United States**HOW MIGHT YOU DEFY IMAGINATION?** · You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission—to serve patient ...
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Amgen Cambridge, United States**HOW MIGHT YOU DEFY IMAGINATION?** · You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission—to serve patient ...
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Process Development Engineering Scientific
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Vertex Pharmaceuticals Boston, United States**Job Description**: · The Process Dev Engineering Scientific Associate will be part of a team responsible for the development, optimization, and characterization of cell culture processes for ongoing and future projects. · **Thursday-Monday Shift** · **General Summary**: · The P ...
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Scientist Ii, Upstream Process Development
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Ensoma Boston, United StatesWe are seeking a motivated and experienced Upstream Process Development Scientist to lead process development efforts for cutting edge adenoviral vector production processes, and implementing them in manufacturing. · You will join a team of scientists and engineers dedicated to b ...
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Software developer for image processing
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Radiant Ventures Mendon, United StatesFounded in 1980, IMS Messsysteme GmbH is now the world leader in X-ray, isotope, and optical measurement systems with headquarters in Heiligenhaus (NRW) and branches around the globe. The top 20 largest steel and aluminum manufacturers worldwide trust our innovative, high-precisi ...
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Process Development Engineer
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Boston Metal Woburn, United StatesProcess Development Engineer · Boston Metal is commercializing cutting edge extractive metallurgy technology that will revolutionize primary metals production, while decreasing cost and lowering environmental impact. This fast-paced startup company is looking for a Process Develo ...
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Process Development Engineer
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Boston Metal Woburn, United StatesProcess Development Engineer · Boston Metal is commercializing cutting edge extractive metallurgy technology that will revolutionize primary metals production, while decreasing cost and lowering environmental impact. This fast-paced startup company is looking for a Process Deve ...
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Process Development Manager
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Alkermes Waltham, United StatesJob Description · The Process Development Manager manages the pilot scale process development facility and personnel and provides technical guidance for small molecule process development, scale-up and technical transfer of developed processes to manufacturing. The successful ca ...
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Process Development
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Director, Process Development
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Alkermes Watertown, United StatesJob Description · An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development leadership team with responsibility for process development activities within the business, ensuring delivery of robust processes that enable the consist ...
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Process Development Scientist
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Garuda Therapeutics Watertown, United StatesGaruda Therapeutics, a biotechnology company focused on developing off-the-shelf human hematopoietic stem cell-based cellular therapies, is seeking a highly motivated Scientist to join its growing team. The full-time role will be a key member of the process development team, focu ...
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Process Development
1 week ago
Quanterix Billerica, United StatesJob Description · Job DescriptionQuanterix is a company that is digitizing biomarker analysis with the goal of advancing the science of precision health. The company's ultra-sensitive detection solution, Simoa, has the potential to change the way in which healthcare is provided t ...
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Process Development Manager
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Alkermes Watertown, United StatesJob Description · The Process Development Manager manages the pilot scale process development facility and personnel and provides technical guidance for small molecule process development, scale-up and technical transfer of developed processes to manufacturing. The successful ca ...
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Process Development
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Quanterix Billerica, United StatesJob Description · Job DescriptionQuanterix is a company that is digitizing biomarker analysis with the goal of advancing the science of precision health. The company's ultra-sensitive detection solution, Simoa, has the potential to change the way in which healthcare is provided t ...
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Process Development Engineer III
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Process Development Engineer III
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Werfen Bedford, United StatesOverview · Werfen · Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. · We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Origi ...
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Process Development Engineer III
2 weeks ago
Werfen Bedford, United StatesOverview · Werfen · Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Origina ...
Scientist/Senior Scientist, Process Development - Lexington, United States - Keros Therapeutics
Description
This role is responsible for providing overall support in early stages of process development and acting as an interface with the Research and CMC organizations.
The Senior Scientist is responsible for leading projects focused on developing, optimizing, and scaling cell lines and fed-batch processes for biologics manufacturing and other applications.
The Sr. Scientist will also be responsible for tech transfer activities for external manufacturing.Primary Responsibilities:
Qualifications:
