General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for chemical development and CMC-related aspects of chemical development involving clinical development programs in Phase 2, Phase 3 (including validation activities), and commercial programs. This individual will participate on the CMC project teams and collaborate closely with other functions, including Analytical and Formulation Development, Non-Clinical Development, Process Development, Quality, Regulatory, and Supply Chain to support later stage development programs and to support validation and commercialization activities.

Roles and Responsibilities

• Oversee process development planning and execution for clinical phases, including route development, process scale up, particle control, development of starting material and impurity control strategies, process validation and associated activities, and manufacture of GMP drug substance.

• Actively contribute to IP/patent-related activities.

• Partner closely with other functions, including Analytical and Formulation Development, Non-Clinical Development, Process Development, Quality, Regulatory, and Supply Chain.

• Participate on CMC teams and oversee execution of chemical development activities at external contract research organizations and manufacturing facilities.

• Author and review drug substance-related sections of regulatory filings.

• Drive to achieve the best development and business results for SAGE across all stages of development.

• Perform other tasks as assigned or as required for a given program.

Experience, Education and Specialized Knowledge and Skills
The successful candidate has a proven track record in chemical development for clinical stage programs using phase appropriate strategies. In addition, the candidate has a broad understanding of pharmaceutical development and CMC-related activities, including process analytical development and formulation development. 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 contract research organizations and manufacturing facilities are a must.

Basic Qualifications

• Advanced degree in organic chemistry; PhD preferred.

• 7+ years of relevant small molecule chemical development, scale up, and CMC experience in the pharmaceutical industry.

Preferred Qualifications

• Demonstrated ability to manage outsourced process development and manufacturing activities in a virtual environment, both domestically and internationally.

• Strong problem-solving skills and ability to multitask and succeed in a fast moving and dynamic environment.

• Excellent verbal and written communication skills; ability to effectively work across levels, functions, and companies.

• Ability to travel up to 30%.

• Experience in writing regulatory documents and submissions.

• Direct experience in process validation and authoring CMC sections of NDAs is an advantage.

• Quality and project management experience is a plus.

• Embrace 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.

Equal Opportunity Employer. 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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PAY TRANSPARENCY NONDISCRIMINATION

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.