Responsibilities:
- Lead formulation and process development projects across the product lifecycle: pre-formulation, dosage form selection, formulation development, process development, and manufacturing scale-up.
- Design, execute, and interpret formulation and process development experiments in outsourced environments (contract laboratories and CDMOs).
- Identify and vet new contract organizations to support formulation and process development.
- Help define and execute project plans for formulation lifecycle management.
- Support writing technical sections for intellectual property and regulatory filings.
- Develop and maintain in-depth knowledge of formulation development trends, techniques, and technologies.
- Serve as a formulation development subject matter expert within Pharmaceutical Development and across the company.
- Summarize, document, and present information to subgroup, group, and cross-functional audiences.
Qualifications:
- Ph.D./M.S./B.S. in Pharmaceutical Science, Chemical Engineering, Chemistry, Biochemistry, Biochemical Engineering, or related fields.
- 7+ years pharmaceutical development experience (preferred: 4+ years industry for Ph.D; 5+ for M.S.; 7+ for B.S.).
- Demonstrated formulation and drug product development experience, preferably for small molecules.
- Deep understanding of sterile, parenteral dosage form formulation considerations; other dosage forms (e.g., ophthalmic/oral) beneficial.
- Experience with injectable drug-device combination products (e.g., prefilled syringes, autoinjectors) preferred; other delivery techniques beneficial.
- Preferred: technical expertise for poorly water-soluble APIs; desirable expertise in one or more: nano-milling/nanosuspension, micro/nano-emulsions, salt formation/screening, cyclodextrin/co-solvent complexation/co-solvency, lyophilization.
- Experience with physicochemical characterization methods for drug substances and drug products.
- Excellent written/verbal communication; strong interpersonal and organizational skills; attention to detail; strong technical/analytical skills (MS Office).
- Ability to work independently or as part of a team; strong decision-making; adaptability; positive professional attitude.