CMC Development Program Manager, Small Molecules

Location Belgium
Discipline: Biotechnology, Pharmaceutical
Job type: Permanent
Contact name: Cherish Becker

Contact email: c.becker@panda-int.com
Job ref: 11117
Published: about 1 month ago

Your responsibilities:

  • Lead Chemistry, Manufacturing and Controls (CMC) activities for small molecule development projects
  • As a member of the development team reporting to the Chief Development Officer, work with the team and with CMC consultants and designated contract development and manufacturing organizations (CDMOs) to facilitate successful project execution, achievement of key deliverables and of budget and FTE goals
  • Collaborate cross functionally with internal and external stakeholders such as Discovery, Regulatory Affairs, Toxicology, Medical / Clinical and Quality
  • Lead and contribute as appropriate to internal and external scientific / CMC discussions
  • Provide CMC support to project teams by:
    • Building project timelines and managing the critical path
    • Translate strategies into CMC operational plans
    • Developing CMC project budgets and budget forecasts
    • Developing and analyzing scenarios, risk assessment and mitigation planning
    • Participate in consultant and CRO selection activities
    • Develop, liaise with and manage resources (FTE, CRO and consultant budgets)
    • Team governance support as required
    • Support monthly, quarterly and major financial budget cycles

Your profile – Technical Skills:

  • PhD or equivalent in a scientific discipline, or/and at least 7 years of relevant experience in the pharmaceutical industry and drug development is essential
  • Knowledge of and experience in small molecule drug development, specifically CMC functions, is essential, including e.g. familiarity with drug substance (essential) and/or drug product development, analytical development and stability programs, clinical trial materials, manufacturing, and quality and regulatory requirements
  • Experience in Project Management is essential
  • Biologics CMC experience is a plus
  • Experience in clinical development and clinical supplies is a strong plus
  • MS Project knowledge is a strong plus
For more information please contact me at:  +31 (0)20 20 44 502 or c.becker@panda-int.com