Senior Manager/ Assoc Director Formulation

11/30/22

King of Prussia, PA

1868

The Senior Manager/Associate Director of Formulation will 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. This role will be responsible for:

  • Drug Product Formulation, including 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 resources; development of all supporting documentation for technical products; and development of project timelines aligned to business goals
  • 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 that are sent to Health Authorities according to regulatory/company timelines; work with quality and provide SME input to ensure all LIR/OOS/NC issues are raised, risk-assessed and driven to completion in a timely manner; oversee the compilation of required CMC sections for all required FDA submissions (eg NDA submissions, annual reports, etc) pertaining to drug product design and improvements; actively identify and author key SOPS required to enable compliance related to data generation, handling and manipulation
  • Operational Excellence, to include acting as 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

Requirements:

  • PhD degree in Physical Pharmacy, Chemical Engineering or related field. At least 5+ years of progressively responsible experience in Drug Product development within the pharmaceutical and/or medical device industries
  • Sterile experience preferred
  • Must have knowledge of the relevant regulations, regulatory process, and requirements
  • Experienced in topical and sterile Drug Product development
  • Must have demonstrated experience in managing teams of diverse backgrounds at CRO/CDMOs
  • Strong written and oral communications skills
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