-
ID
#16860003 -
Job type
Permanent -
Salary
TBD -
Source
Apex Systems -
Date
2021-07-15 -
Deadline
2021-09-13
Director/Senior Director, Antibody CMC
Massachusetts, Woburn, 01801 Woburn USAPermanent
Vacancy expired!
Director/Senior Director, Antibody CMC 1145636 Job Scope & Purpose: Our Greater Boston area client is seeking an experienced and highly motivated individual to lead CMC activities for its lead therapeutic antibodies. The successful candidate will have a strong technical understanding of CMC activities for biologics and antibodies, including upstream and downstream process development, formulation, and manufacturing, as well as direct experience with filing multiple INDs (and ex-US filing experience is strongly preferred). Want to learn more? Reach out to Kevin Rees today. Primary Job Responsibilities:
- Defining a CMC strategy for the company
- Evaluation, auditing, negotiation and contracting with Contract Manufacturing Organizations (CMOs), an overseeing activities at these partners
- Management of timelines and budgets for manufacturing and CMC initiatives
- Authoring CMC sections of INDs
- Oversee the management and buildout of an internal protein analytics team
- Primary Job Requirements:
- PhD with 6+ years, or MS with 10+ years of experience in biologics and/or antibody manufacturing, process development, or protein analytics
- Extensive knowledge of all technical aspects of IND-enabling CMC activities
- Strong familiarity with current CMC regulatory guidelines in the US, with strong preference for familiarity with regulatory guidelines in Europe and Asia
- Experience with CMO selection, initialization and oversight of activities required
Vacancy expired!
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