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Associate Director, CMC and External Manufacturing in Cambridge, MA at Apex Life Sciences

Date Posted: 12/2/2018

Job Snapshot

Job Description


Job Scope & Purpose:

Stratacuity's exceptional Cambridge-based immunotherapy client, who is dedicated to developing a novel, proprietary class of biologics engineered to selectively modulate the human immune system and treat a broad range of cancers and autoimmune disorders, is seeking a dedicated and experienced Principal Scientist/Associate Director, CMC and External Manufacturing to add to its world-class and highly motivated team. Our client is preparing for its first IND filing in the coming months, so this individual will play a key role in preparation for clinical manufacturing, as well as further development of other pipeline initiatives.

Primary Job Responsibilities:

  • Play critical effort in pharmaceutical development activities

  • Assist in overseeing outsourced CMC functions, including, but not limited to, scale-up manufacturing, protein purification, and stability testing

  • Assist in planning and coordination of all drug product development activities, including analytical development, formulation, and process development, as well as being responsible for specific project execution

  • Serve as a 'person in-plant' for manufacturing efforts with contract manufacturing organizations (CMOs)

Primary Job Requirements:

  • Degree in an applicable field of study (BS with at least 10 years industry experience, MS with at least 6 years industry experience, Ph.D. with at least 3 years industry experience), with expert knowledge in multiple disciplines required

  • Significant experience with biologics required. Experience with internal development and production of fusion proteins strongly preferred experience with mAb preferred.

  • Significant previous experience with managing multiple CMOs required. 

  • Experience supporting multiple global clinical trials strongly preferred.

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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