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Associate Director, Small Molecule Drug Product Manufacturing
Ref No.: 17-11532
Location: South San Francisco, California
Position Type:Direct Placement
Associate Director, Small Molecule Drug Product Manufacturing
Location: South San Francisco, CA

The Associate Director, Small Molecule Drug Product Manufacturing will be a liaison for the manufacture of our small molecule development and commercial drug products (DPs) at external contract manufacturing organizations (CMOs). This individual will work in a cross functional team environment with colleagues from process development, QA, QC, analytical, formulation development, regulatory and supply chain to plan, coordinate, and execute external DP manufacturing activities. In addition, the successful candidate will collaborate in formulation process improvements, technology transfers, scale-up, troubleshooting of process related issues and root cause analysis for manufacturing deviations and investigations. The Associate Director will also ensure that drug product timelines and budgets are met.

  • Plan and implement DP formulation development and manufacturing activities within our organization and across its suppliers in accordance with documented work orders and cGMP requirements
  • Author, review and approve documents related to GMP operations as requested and appropriate including DP MBRs and EBRs
  • Interface directly with counterparts at CMOs to maintain accurate inventory of drug product quantities and oversee the shipment of drug product to toxicology and clinical study sites
  • Oversee the shipment of drug product to the clinical and commercial labeling and packaging sites as necessary
  • Oversee the technology transfer of drug product processes into CMOs
  • Oversee the implementation of process improvements into drug product CMOs
  • Support the late stage formulation development activities including process validation batch planning and PAI preparations
  • Participate in Continuous Process Verification (CPV) process
  • Act as Person in Plant to provide oversight of CMO drug product manufacturing activities
  • Monitor deviations and process/operational changes; ensure appropriate technical and management visibility within the organization to these events and facilitate feedback and decisions to the CMOs
  • Participate in preparation, review and approval of CMC sections of regulatory filings
  • As a member of internal and external CMC teams, develop and execute project plans ad schedules that represent the appropriate level of detail and task independency and have accurate resource planning estimates to support development team objectives
  • Participate in periodic business and technical review meetings with relevant DP CMOs
  • Keep management informed of any significant risks to CMC timelines and/or budgets relating to drug product manufacturing
  • Ability to travel up to 40%
  • BS/MS degree in Pharmaceutics, Chemistry or comparable scientific degree
  • 8-10+ years of experience in the Biotech or Pharmaceutical industry focused on small molecule drug product development and manufacturing (experience in a commercial manufacturing environment is preferred)
  • Experience working in a contract manufacturing environment including a working knowledge of small molecule drug product validation and experience with regulatory submissions (previous PAI experience would be helpful)
  • Established and demonstrated project management skills (good working knowledge of Excel and Project a plus)
  • Strong written and verbal communication and interpersonal skills
  • Hands-on individual with a collaborative personal style and the ability to work well in a fast moving team/collaborative environment