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!
