General Scope and Summary
SAGE Therapeutics is searching for a technical leader for a highly-visible role as Director, Analytical Development. The successful candidate will be responsible for analytical development and related activities at third party laboratories for the earlier phases of development, and will collaborate closely with other CMC related functions including discovery, toxicology, manufacturing, quality and regulatory in order to advance Sage’s fast growing portfolio of products.
Roles and Responsibilities
- Oversee analytical strategy, planning and execution for Sage’s early phase portfolio of products and work closely with other CMC related functions.
- Oversee all analytical activities conducted at third party labs including structure elucidation, method development and validation, stability studies, method transfer, testing of clinical materials and reference standards.
- Support GMP, GLP and GCP activities, including investigations.
- Provide input and data for regulatory filings.
- Actively contribute to program teams, and ensures alignment of analytical activities with the program development plans.
- Actively communicate, collaborate with and contribute to other functional areas and drive to achieve the best development and business results for the company.
Experience, Education and Specialized Knowledge and Skills
The successful candidate has a broad understanding of analytical sciences and regulatory/GMP requirements, and a proven track record in analytical development for early clinical stage programs. Discovery and/or QC experience are a plus. 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 setting with external laboratories and manufacturing facilities are a must. Other requirements are:
- Advanced degree in Chemistry, Chemical Engineering or related field, PhD preferred
- 10+ years of relevant small molecule analytical experience in the pharmaceutical industry
- Practical experience with a broad range of analytical techniques, charged aerosol detection and/or, microbiological experience is a plus
- Proven track record in managing analytical aspects of development programs in clinical stage, commercial and QC experience are a plus
- Strategic view and leadership abilities as well as hands on problem solving skills
- Excellent verbal and written communication skills, ability to effectively work across levels, functions and companies
- Experience in writing regulatory documents and submissions
- Embraces our 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
- CMC project management skills a plus