POS 3886
Status 5

Project Manager CMC Management

Beschreibung: For one of our Pharma-clients in the greater area of Munich we are seeking freelance support as: Project Manager CMC Management (M/F/D)
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  • Operational coordination of EU-regional CMC development teams (CMC sub-teams) for multiple early and late phase drug development candidates (clinical Phase 1 - launch). Thereby, the portfolio of projects may consist of complex parenteral biopharmaceutical drugs such as Antibody-Drug-Conjugates, but also classical small molecule solid dosage forms:
  • Responsible for the establishment of integrated regional CMC operational plans in alignment with global plans and oversee their execution.
  • Representation of EU CMC development teams on global and regional cross-functional drug development project teams.
  • Ensure alignment of regional CMC operational plans with overall project plans; facilitate the timely execution of drug development project plans through proactive management of operational interfaces between the CMC development team and other functions
  • Provide project management and operational oversight of routine vendor (CXO) services, coordinating timelines, budgets and deliverables, and coordinating the input of technical and functional experts as required; CXO services covered include drug substance manufacturing, drug product manufacturing and analytical testing services
  • Planning and supervision of project related regional budgets
  • Supports regional and global stakeholder management and periodic reporting related to CMC Management
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  • Start: 15.08.2020; latest 01.09.2020 // Duration: 7 months // Capacity: full-time onsite & remote
  • Ph.D. in pharmacy, (bio) chemical engineering, chemistry, biochemistry, or other discipline within pharma/biotech sciences
  • Min. 2 years project experience in pharmaceutical development or production experience, or a corresponding Master’s/Bachelor’s degree with a minimum of 5 years project experience
  • Experience in biologics and small molecule processing, drug substance and drug product development activities and knowledge of CMC regulatory requirements
  • Proven ability to collaborate with functional representatives to anticipate and identify project risks and develop action and resolution plans
  • Proven ability to work effectively with cross-functional stakeholders in a complex/evolving global environment
  • Demonstrated matrix management skills and clear ability to influence and effectively align, motivate and empower the team to progress project goals in a cross-functional team environment
  • Must be flexible in response to changing priorities due to various time zones (EU, US & Japan)
  • Strong working knowledge of Microsoft Office
  • Must have: German & English
Bemerkungen: WANTED: Project Manager CMC Management (M/F/D). Please contact +49 89 18 90 998 53 or Skills: CMC (Regulatory Affairs), English, German, Pharma
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Interesse geweckt?
Auf geht's!
Beginn: 15.08.2020; latest 01.09.2020
Laufzeit: 7 months
Einsatzort: Greater Munich area, Germany
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