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Director, Drug Product Development & Manufacturing in Boston, MA at Apex Life Sciences

Date Posted: 12/2/2018

Job Snapshot

Job Description


Job Scope & Purpose:

Our Greater Boston area client, a leader in the rare disease/neuromuscular space, is seeking an exceptional Director level candidate to establish and coordinate product development for its sterile injectable programs as well as external manufacturing activities for its broad pipeline of programs.  This leadership role will work cross-functionally with other team leaders in CMC, Supply Chain, Quality, Regulatory Affairs, and Technical Development to implement and manage programs and continuous changes specific to those efforts.

Primary Job Responsibilities: 

  • Recruit, manage and lead a team of internal formulation scientists, CMO Managers, and external partners

  • Manage all drug product programs, including formulation development efforts and external manufacturing strategies

  • Work cross-functionally with Quality Control and Analytical Development in the development of characterized formulations, impurity identification, and method development

  • Write CMC regulatory documents specific to programs

  • Develop new internal and external development capabilities

  • Provide expertise as a person in-plant during tech transfers, validations or routine production

  • Manage release of clinical and commercial product through sterile fill finish manufacturing

  • Review production batch records and manage discrepancies as needed

  • Manage scale-up strategy and implementation for new products 

Primary Job Requirements: 

  • Minimum of MS (Ph.D. strongly preferred) in pharmaceutical sciences, organic chemistry, analytical chemistry, chemical or biochemical engineering

  • Minimum of 12-15 years industry experience and at least four years in a leadership role

  • Experience and knowledge using biochemical or biophysical methods to characterize AAV-based viral vectors strongly preferred

  • Extensive experience and understanding of various formulation approaches required

  • Strong experience required in creating novel drug delivery applications for specific formulation needs

  • Strong knowledge of GMP regulations and requirements such as USP, ICH, JP

  • Occasional domestic and international travel 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 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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