General Scope and Summary
The successful candidate will participate in the formulation and process development of difficult to solubilize drug molecules. 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 Tech Ops/Pharmaceutical Development leadership, CMC Teams, Program Teams, and related functions including: Discovery, Non-Clinical development, Clinical Operations, Process Development, Analytical Development, Quality and Regulatory
- Actively participates as the Formulation Development lead on 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 development, and a proven track record in developing and scaling-up formulations for oral administration for difficult to solubilize compounds using enabling technology platforms such as amorphous dispersions and nanoparticulates, for example, through proof of concept. Excellent leadership, communication and collaboration skills in a cross-functional and fast paced environment, as well as proven ability to achieve results in a virtual/outsourced model, utilizing external laboratories and manufacturing facilities, are a must.
- Advanced degree in Engineering, Materials Science, Pharmaceutics, Chemistry or related field, Ph.D. preferred
- 8+ years relevant small molecule formulation development experience in the pharmaceutical industry
- Extensive experience with formulation technologies for low solubility molecules, specifically the development and scale-up of spray dried amorphous dispersions. Experience with other enabling technologies such as hot-melt extrusion, nanoparticles, lipids, etc. a plus. Savviness for balancing between implementing both fit-for-purpose and innovative approaches to problem solving, based on program requirements.
- Responsible for managing pre-formulation, formulation development, delivery of clinical supplies, development of efficient and scalable manufacturing processes in alignment with Company goals
- Review of manufacturing batch records and other documentation
- 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.
- Experience with PBPK modeling and related software is a plus
- 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, if applicable)
- Prior experience in authoring and reviewing drug product and Module 3/CMC sections of regulatory submissions 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
All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.
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