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Hillevax
Boston, MA, United States
Sr. Scientist, Upstream Process Development HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated
Job Source: HillevaxEnsoma
Boston, MA, United States
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Job Source: EnsomaHireMinds LLC
Boston, MA, United States
Our clinical stage, pharmaceutical client here in Boston, MA is growing and looking to add a Sr. Scientist, Downstream Process Development to their team (onsite 3-4 days/week)! This role will be responsible for providing expertise for the scale up, tech transfer, GMP run readiness of downstream unit operations in support of clinical/commercial manu
Job Source: HireMinds LLCHillevax
Boston, MA, United States
Research Associate, Upstream Process Development HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infectio
Job Source: HillevaxHireMinds
Boston, MA, United States
Our clinical stage pharmaceutical client here in Boston, MA is growing their Process Development team and looking to add a Research Associate, Upstream PD (onsite 3-4 days/week)! Responsibilities include but not limited to: Serve as subject matter expert on fermentation and/or cell culture unit operations. Execute process development activities
Job Source: HireMindsHireMinds
Boston, MA, United States
Research Associate, Upstream Process Development Boston, Massachusetts Our clinical stage pharmaceutical client here in Boston, MA is growing their Process Development team and looking to add a Research Associate, Upstream PD (onsite 3-4 days/week)! Responsibilities include but not limited to: Serve as subject matter expert on fermentation and/
Job Source: HireMindsGarudatx
Burlington, MA, United States
Garuda Therapeutics, a biotechnology company focused on developing off-the-shelf human hematopoietic stem cell-based cellular therapies, is seeking a highly motivated associate / senior associate to join its growing team. The full-time role will be a key member of the process development team, focusing on scaling up pluripotent stem cell expansion
Job Source: GarudatxHireMinds
Boston, MA, United States
Our clinical stage vaccine client located here in Boston, MA is growing and looking to add a Sr. Scientist, Technology Transfer to their Process Development team (onsite 3-4 days/week)! This role will be leading the tech transfers for early and late clinical phase drug substance/drug product, to both internal and external contract development & m
Job Source: HireMindsBoston, MA, United States
SUMMARY
This clinical-stage biopharmaceutical company is looking for an innovative scientist with a strong background in Upstream Process Development to oversee the development of all upstream technical activities for their lead vaccine program. They will also be expected to oversee CRO/CDMOs to make sure all areas of the drug substance process development and manufacture are in compliance with QbD and cGMP requirements, the chosen candidate will work hands-on in the lab with hybrid flexibility.
RESPONSIBILITIES:
Will design, develop, and implement fermentation & cell culture techniques, protocols, and technologies
Assist internal and external partners with the scaling up, tech transfer, optimization, and validation of upstream cell culture and viral vector unit operations in support of clinical manufacturing.
Oversee CDMOs for deliverables and timelines related to upstream tech transfer.
SME for all upstream drug substance actions that support clinical development and IND filing.
Collaborate with the technical team and CDMO partners on process design, optimization, and characterization. Provide technical oversight, guidance, and troubleshooting to help CDMO partners successfully create a reliable and efficient process. Ensure that clinical materials are delivered on schedule and that there are smooth transitions from process development to successful regulatory submissions.
Write and evaluate CMC sections & technical reports needed for regulatory submissions.
QUALIFICATIONS:
Master's or PhD in Chemical Engineering, Microbiology, Biochemistry, or related degree with 4-5 years of industry experience (PhD) or (MS +8 years) developing upstream processes.
Prior hands-on experience with viral vaccines, insect/mammalian, & recombinant proteins is highly desired.
Track record of successfully organizing and managing deliverables internally and external (CMO Management is a PLUS).
Solid understanding of the ICH Q8 criteria for pharmaceutical development and to use the concepts of quality by design to create scalable, reliable upstream procedures.
Expertise in using statistical software (JMP, R, etc.) for DOE, tracking and trending data, and data presentation in project teams.
BENEFITS
Hybrid Flexibility (3-4 days)
Unlimited PTO
401k & Stocks
Medical, Dental, Vision, Insurance
MUCH More!
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Email Alert for Sr. Scientist, Upstream Process Development jobs in Boston, MA, United States
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