Director, Drug Product Manufacturing

General Scope and Summary

SAGE Therapeutics is searching for an experienced technical leader for a highly visible role as Director, Drug Product Manufacturing. The successful candidate will be responsible for overseeing external manufacturing and technology transfer activities for phase 3 and commercial drug product, including process validation and supporting development and clinical supplies activities. The successful candidate will collaborate closely with other Sage functions, including Quality, Regulatory, Pharmaceutical Development, Analytical Development, Process Development, and Supply Chain to advance Sage’s fast growing portfolio of products.

Roles and Responsibilities

• Oversee commercial manufacturing operations at external manufacturing partners for sterile drug product.

• Oversee technology transfer and process validation activities at new external manufacturing partners in close collaboration with Process Development, Quality, and the CMC teams.

• Manage technical and process changes for commercial manufacturing in close collaboration with Quality, Regulatory, and other involved functions.

• Actively manage manufacturing risks and improvements.

• Support clinical manufacturing and development activities.

• Lead technical development teams, e.g. tech transfer teams or technical project teams.

• Actively contribute to CMC teams and ensure alignment of manufacturing and technology transfer activities with CMC and 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 experience in pharmaceutical manufacturing of Oral Solid Dosage Forms and sterile drug products, as well as a proven track record of solving complex technical issues. Experience in sterile drug products and lipid formulations is 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.

Basic Qualifications

• Advanced degree in engineering, science, or related field.

• 8+ years of relevant manufacturing, engineering, and development experience in the pharmaceutical industry; technology transfer and validation experience required.

• Experience managing CDMOs.

• Up to 50% business-related travel.

Preferred Qualifications

• 10+ years of relevant manufacturing, engineering, and development experience in the pharmaceutical industry; Oral Solid Dosage Forms, technology transfer, and validation experience required. Experience with sterile product and lipid formulation manufacturing is 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.

• Strong team player that has a customer service approach and is solution-oriented.

• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

• Possesses strong written and verbal communication skills.

• 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.

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.