Director of Manufacturing in Lexington, MA at Apex Life Sciences

Date Posted: 11/2/2018

Job Snapshot

Job Description


Job Scope & Purpose:

Our exceptional small, privately owned and clinical stage Greater Boston area client, developing novel delivery approaches to cell therapy (via a device platform, is seeking a dynamic leader to manage all aspects of manufacturing.  This individual will focus on overseeing external partners (CMOs) producing cells (drug substance) and focusing on a biologic-device combination (drug product).  This leader will build and lead a dynamic team to drive process engineering for all manufacturing needs through to mid and late-stage clinical trials and commercialization.  Opportunities like this do not come along often – so reach out to Todd Jamison and his team to learn more!

Primary Job Responsibilities:

  • Optimize current processes and develop a next-generation process focused on supplying cells and final product for future clinical and commercial efforts
  • Manage existing CMOs producing cell banks and expanding operations needed to supply clinical inventory
  • Manage external partners focused on the biologic-device combination
  • Build and lead a team dedicated to manufacturing and process engineering
  • Serve as a technical Subject Matter Expert on all manufacturing initiatives internally

Primary Job Requirements:

  • Degree in a relevant biologic or engineering discipline, with a minimum of 10 years’ industry experience
  • Must have significant experience in developing and managing FDA-regulated cellular GMP manufacturing
  • Previous supervisory and leadership experience is required
  • Relevant management experience in an FDA biologics regulated environment strongly preferred
  • Previous experience in the creation of, or significant contributions towards CMC sections of an IND and/or BLA
  • Ability to travel 10-20%

To Be Successful, an Ideal Candidate must have:

  • Strong roots in Cell Therapy/Biology – the mechanical/automation foundation is based on an understanding of HOW cells react
  • Regulatory knowledge on requirements associated with combination products
  • Understanding what it takes to be successful in a small company
  • Creativity and confidence to find solutions to problems and be comfortable with ambiguity in a relatively new arena of development

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 at info@stratacuity.com or 877-787-2821.

Code: TechOps

EEO Employer

Apex 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. 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 844-463-6178.




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