18 May
Director/Senior Director, Antibody CMC
Massachusetts, Woburn , 01801 Woburn USA

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
About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.Code: TechOpsEEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or


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