Senior Director, Formulation Development

General Scope and Summary

The successful candidate will participate in establishing formulation development strategy for difficult to solubilize products. This individual will help develop formulation development strategies and plans and integrate these plans in alignment with evolving integrated development plans, including lifecycle opportunities, and oversee selection of and execution at external partners.

Roles and Responsibilities

• Help develop strategy and formulation development plans for difficult to formulate products in close collaboration with the Vice President, Pharmaceutical Development, project and CMC teams, and related functions, including Research, Non-clinical Development, Process Development, Analytical Development, Quality, and Regulatory.

• Actively manage the formulation development group, which oversees pre-formulation, formulation development, and early clinical manufacturing activities at external laboratories and manufacturing facilities.

• Review and approve formulation-related sections for regulatory filings, development reports, and other development-related documents.

• Actively communicate, collaborate with, and contribute to other functional areas and drive to achieve the best development and business results for SAGE.

• Identify life cycle opportunities for future formulations and obtain alignment with key stakeholders to execute on a development and commercialization plan.

Experience, Education and Specialized Knowledge and Skills

The successful candidate has a broad understanding of formulation development as it relates to different routes of administration and CMC activities and a proven track record in developing formulations for oral, parenteral, and mucosal administration for difficult to solubilize products through clinical proof of concept. Excellent leadership, communication, and collaboration skills in a cross-functional and fast paced environment, as well as a proven ability to achieve results in an outsourced model utilizing external laboratories and manufacturing facilities are a must.

Basic Qualifications

• Advanced degree in Pharmaceutics, Chemistry, or related field; PhD preferred.

• 15+ years of relevant small molecule formulation development and CMC experience in the pharmaceutical industry.

Preferred Qualifications

• Extensive experience with formulation technologies for low solubility molecules, e.g. lipids and spray dried dispersions, etc.

• Responsible for managing pre-formulation, formulation development, delivery of clinical supplies, and identification of efficient and scalable manufacturing processes in alignment with Company goals.

• Experience and knowledge in the interplay between the absorption process and PK/PD relationships with formulation modality is desired.

• Experience and knowledge in physiologically-based pharmacokinetic modeling and simulation 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).

• Review drug product sections in the CMC sections of regulatory submissions.

• Embraces our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

• Excitement about the vision and mission of Sage.

All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.  Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

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.

EEO is the 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.