Director, Drug Product Manufacturing
Company: Sage Therapeutics
Posted on: August 6, 2022
**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
**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
+ 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.
+ 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.
+ 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
+ Strategic view and leadership abilities as well as hands-on
+ 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
+ Attention to detail and the ability to work individually, within
a multi-disciplinary team, as well as with external partners and
+ 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.
**Number of Openings:**
**#Biotechnology #Careers #ThisIsSage**
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
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.
Protected personal characteristics include: age, race, ancestry,
color, sex, national origin, sexual orientation, gender identity or
expression, religious creed, mental or physical disability,
pregnancy, genetic information, marital or civil union status,
participation in the uniformed services of the United States, or
any other characteristic protected under applicable federal, state
or local law. To learn more, see Sage's Anti-Harassment and Equal
Keywords: Sage Therapeutics, Cambridge , Director, Drug Product Manufacturing, Executive , Cambridge, Massachusetts
Didn't find what you're looking for? Search again!