What are the responsibilities and job description for the Manager, Upstream Process Development position at Third Rock Ventures?
Manager, Upstream Process Development and Manufacturing
A Third Rock Ventures Stealth NewCo is seeking a Manager, Upstream Process Development and Manufacturing, to join an experienced, professional and collaborative CMC team. This position will offer tremendous opportunities to advance clinical programs by leading cell line development, upstream process development, process optimization, scale-up and GMP production activities through the active management of external CDMOs. Successful candidates will be innovative, thrive in a startup environment and use their creative and imaginative problem-solving skills to help bring new products to patients.
RESPONBILITIES
- Work collaboratively with discovery, non-clinical, clinical, and CMC teams to develop and deliver phase-appropriate materials for animal and clinical studies.
- Develop robust upstream process for novel protein therapeutics for early/late-stage development.
- Oversee CDMOs for phase appropriate upstream process development activities, utilizing small scale bioreactors such as Ambr system to support process development, process optimization, such as media selection, pH setpoint and deadband, feeding, clone selection, etc.
- Oversee CDMOs to scale-up upstream process to support smooth technology transfer and manufacture activities. Review process description document, BOMs, PFDs, and batch records, manage deviation investigations. Act as person in plant for key GMP events.
- Author and review technical development reports and related sections of regulatory filings such as IND, IMPD, etc.
- Contribute to other aspects of CMC activities as needed.
EDUCATION REQUIREMENTS AND QUALIFICATIONS:
- Ph.D. in Chemical Engineering, Biology, Biochemistry, or related discipline with a minimum 2 years industry experience developing upstream process (or MS with 5 years or BS with 8 years).
- Hands-on experience in upstream process development, technology transfer and manufacturing processes using Quality-by-Design (QbD) principles and DoE designs.
- A good working cGMP knowledge, experience reviewing batch records.
- Experience with statistical analysis and statistical software is a plus.
- Cell line development expertise or experience managing CROs to support cell line development in new clinical projects is a plus.
- Goal oriented team player with excellent communication skills, flexibility, and ability to work in a fast-paced environment with multiple teams across the company.
