A Third Rock Ventures Stealth NewCo is seeking a Formulations Scientist/ Senior Scientist and Drug Product Lead who is interested in establishing core operations of a new team. This position will be a laboratory-based role and will offer tremendous opportunities to advance programs, develop new workflows, implement devices, and build a laboratory. 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 formulations for novel protein therapeutics and dosage forms for early/late-stage development.
- Establish an internal formulation development laboratory with analytical capabilities and execute studies (formulations screening, DP in-use/compatibility, etc.) for drug candidates.
- Manage contracted manufacturing organizations (CMOs) to scale-up formulations and to support DP technology transfer activities and DP deviations/investigations as needed.
- Author technical development reports and author/review relevant sections of regulatory filings such as IND, IMPD, etc.
EDUCATION REQUIREMENTS AND QUALIFICATIONS:
- Ph.D. in Pharmaceutics, Material Sciences, Engineering or related discipline with a minimum 2+ years industry experience (or MS with 5+ years or BS with 8+ years) developing formulations.
- Hands-on experience developing formulations and manufacturing processes using Quality-by-Design (QbD) principles for various dosage forms, to meet phase appropriate requirements of the drug product.
- Experience with Biologics, high concentration formulation development, SEC, CE-SDS, cIEF, biophysical characterization, and sub-visible particle measurements required. Experience with Fc-fusion molecules or similar complex biologics molecules is a plus.
- A good working knowledge of designing efficient experiments (DOE) and statistical techniques for data analysis.
- Goal oriented team player with excellent communication skills, flexibility, and ability to work in a fast-paced environment with multiple teams across the company.
- Experience with device development is a plus.