SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for leading CMC project teams and collaborating closely with all involved functions, including Non-clinical Development, Clinical Development, Pharmaceutical Development, Technical Operations, Quality, Regulatory and Project and Portfolio Management to advance development compounds from preclinical to commercial stage.
Roles and Responsibilities
Facilitates CMC team meetings and establishes detailed CMC program plans including activities, timelines and budgets in alignment with the overall development program and company goals
Oversees execution of CMC-related development and manufacturing activities at external laboratories and manufacturing facilities
Ensures effective communication, collaboration and documentation of all CMC aspects of the program, including preparation of reports and regulatory filings
Identifies CMC-related risks and facilitates mitigation planning
Actively communicates and collaborates with and contributes to other functional areas and drives timelines 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, chemical and formulation development, and a proven track record in CMC development for clinical stage programs. The successful candidate also understands the complexities of working in a highly regulated and quality driven environment. He or she possesses 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. Other requirements are:
Advanced degree in Chemistry, Chemical Engineering or related field, Ph.D. preferred
12+ years relevant small molecule CMC experience in the pharmaceutical industry
Strategic and leadership abilities as well as hands on problem solving skills
Relevant project management and team leadership experience
Excellent verbal and written communication skills, ability to effectively work across levels, functions and with both internal and external stakeholders.
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
This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described. Other duties may be added, or this description amended at any time at the sole discretion of Sage.Employment Type: Employee Number of Openings: 1 Job ID: R000623 #Biotechnology #Careers #ThisIsSage
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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