Title: Principal Scientist/Associate Director of Formulation Development
Reports to: Director of Formulation Development
General Scope and Summary
The successful candidate will participate in the formulation and process development of difficult to solubilize drugs. He/she will help develop and integrate innovative formulation development strategies and plans, in alignment with evolving cross-functional and project team goals and activities. The candidate will also oversee strategic vendor partner selection and drive technical and operational activities in collaboration with SAGE’s external partners.
Roles and Responsibilities
- Helps develop strategy and formulation development plans for technically challenging, low solubility compounds in close collaboration with the Director of Formulation Development, Head of Pharmaceutical Development, Project and CMC teams and related functions, including discovery, non-clinical development, process development, analytical development, Quality and Regulatory
- Actively participates in CMC teams and oversees formulation development and clinical manufacturing activities at external laboratories and manufacturing facilities
- Authors formulation related sections for regulatory filings, development reports and other development related documents
- Actively communicates, collaborates with and contributes to other functional areas and drives to achieve the best development and business results for SAGE
Experience, Education and Specialized Knowledge and Skills
The successful candidate has a broad understanding of formulation and CMC development, and a proven track record in developing formulations for oral administration for difficult to solubilize compounds through proof of concept and process validation. Excellent leadership, communication and collaboration skills in a cross-functional and fast paced environment, as well as a proven ability to achieve results in a virtual/outsourced model, utilizing external laboratories and manufacturing facilities, are a must. Other requirements are:
- Advanced degree in Engineering, Materials Science, Pharmaceutics, Chemistry or related field, Ph.D. preferred
- 6+ years relevant small molecule formulation development and CMC experience in the pharmaceutical industry
- Extensive experience with formulation technologies for low solubility molecules, e.g. nanoparticles, lipid-based, amorphous dispersions, hot-melt extrusion, etc. Savviness for balancing between implementing both fit-for-purpose and innovative approaches to problem solving, based on program requirements.
- Experience in managing pre-formulation, formulation development, review of manufacturing batch records, master formulas, delivery of clinical supplies, and development of efficient and scalable manufacturing processes in alignment with Company goals
- Experience and knowledge in scaling up solids and powder processing unit operations, and participating in tech transfer activities
- Extensive knowledge about the interplay between bioavailability and PK/PD relationships, with respect to formulation modality is desired.
- Strategic view as well as hands on problem solving skills
- Excellent verbal and written communication skills, ability to effectively work across levels, functions and companies (up to 30% travel)
- Prior experience in authoring and reviewing drug product and Module 3/CMC sections of regulatory submissions
- CMC project leadership experience is a plus
- Embraces SAGE’s core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of SAGE