Director of Formulation Small Molecules
My team and I just partnered with an exciting Biopharma that is expanding their drug product CMC team. You will lead the formulation development efforts for our assets, collaborating closely with CDMO teams, internal stakeholders, and driving fast-paced decision-making.
Key Responsibilities:
- Collaborate with CDMOs, CMC colleagues, and stakeholders to advance product design for enhanced stability, efficacy, patient experience, cost-efficiency, and marketability.
- Direct and oversee product development and testing at CDMOs.
- Write and review RFPs, batch records, technical reports, and related documents.
Requirements
- Collaborate with CDMOs, CMC colleagues, and stakeholders to advance product design for enhanced stability, efficacy, patient experience, cost-efficiency, and marketability.
- Direct and oversee product development and testing at CDMOs.
- Stay updated on emerging technologies and foster partnerships with innovators and KOLs for timely adoption.
Qualifications
- Extensive experience in protein formulation and development, especially with monoclonal antibodies and related products.
- A BS/MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or a related life sciences field is highly desirable; PHD preferred
- Broad knowledge of CGMP and regulatory requirements for early and late-stage assets. Advanced degree preferred.
Please reach out to my email
