Associate Director Formulation

  • Location: West Chester, Pennsylvania
  • Type: Direct Hire
  • Job #17627

Associate Director Formulation

Location: West Chester, PA

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Summary

Associate Director Formulation will be responsible twill be responsible for providing formulation design for clinical and commercial development including vendor management, authoring of relevant sections of regulatory submissions, and accountability for drug product design inclusive of formulation and primary packaging, tech transfer, and process improvement.

 

Responsibilities

Education

• PhD degree in Physical Pharmacy, Chemical Engineering or related field

Requirements

  • 5+ years of progressively responsible experience in drug product development within pharmaceutical and/or medical device 
  • Technical oversight of all drug product process development and validation activities; change activities associated with drug product manufacturing processes.
  • Direct external consultants, contract labs, contract supplier technical teams and other external technical resource.
  • Data Quality and Regulatory, including review and/or prepare all 3.2.P data alongside analytical colleagues to be used in regulatory submissions including INDs, milestone briefing packages (Pre IND/NDA Meetings, EOP2 Meetings, and Type A and Type C Meetings), NDAs, and other major US/Global regulatory submissions.
  • Formulation Subject Matter Expert across the business to impact decision in clinical, non-clinical, regulatory, operations and product development; develop and maintain strong relationships with key stakeholders and external SMEs as needed.

For immediate consideration, email lisabarrett@scientificsearch.com and reference JO#17627

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