Associate Director, CMC Project Lead
Company: SAGE Therapeutics
Location: Cambridge
Posted on: June 10, 2021
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Job Description:
General Scope and Summary SAGE Therapeutics is searching for a creative, resourceful,
integrative thinker for a highly visible role that is responsible
for leading CMC product teams and collaborating closely with all
involved functions, including Pharmaceutical Development, Technical
Operations, Quality and Regulatory 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 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. Basic Qualifications Advanced degree in Chemistry, Chemical Engineering or related
field, Preferred Qualifications Ph.D. preferred 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 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. 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. EEO is the Law EEO is the Law - Poster Supplement 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.
Keywords: SAGE Therapeutics, Cambridge , Associate Director, CMC Project Lead, Other , Cambridge, Massachusetts
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