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Senior Manager CMC Management (m/f/x)

  • Location: Munich
  • Salary: negotiable per year
  • Job Type:Permanent

Posted 10 days ago

  • Sector: Biotech
  • Contact: Sebastian Gotzler
  • Contact Email: s.gotzler@sciproglobal.de
  • Start Date: asap
  • Expiry Date: 20 October 2022
  • Job Ref: RA_2022_37_1663683913

Senior Manager CMC Management (m/f/x) | Munich | Pharma

In this role, you will be mainly accountable for the management of late-stage pharmaceutical development activities in EU countries, including tasks such as commercial product development, scale-up, tech transfer to external and internal manufacturing partners, clinical trial material production, process validation and regulatory submission.

What will your tasks as "Senior Manager CMC Management (m/f/x)" be?

  • Matrix leadership and coordination of EU CMC development teams (EU CMC sub-teams) for drug development candidates in clinical-phase as well as life-cycle management and post-approval manufacturing expansions
  • Responsible for the establishment of integrated global and regional CMC operational plans and overseeing their execution. This includes strong alignment with the involved subject-matter expert functions such as Drug Substance Development, Drug Product Development, Analytics, QP, Quality Assurance, Regulatory, Clinical supplies, and Supply Chain
  • Provide project management and operational oversight of vendor (CXO) services, managing 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
  • Representation of CMC sub-teams on cross-functional drug development and life cycle management project teams
  • Ensure alignment of 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
  • Representative in global Working Teams and initiatives to transform and optimize CMC Management, CMC Planning, and global PT function

Your requirements as a "Senior Manager CMC Management (m/f/x)"?

  • University degree in Life Science or Pharmacy, PhD preferred
  • 3+ years experience in pharmaceutical / CMC development and/or production
  • Strong experience and know-how in drug substance and drug product development, and/or production of biopharmaceuticals.
  • Hands-on late-stage scale-up and production experience in monoclonal antibody production (downstream and/or upstream)
  • Experience in late-stage development of complex biopharmaceutics such as Antibody-Drug Conjugates or other new antibody formats
  • Proven know-how to collaborate with functional representatives to anticipate and identify project risks and develop action and resolution plans
  • 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 the team to progress project goals in a cross-functional environment
  • Strong Microsoft Office working knowledge
  • English is a must have; any other language would be a plus

Information about our client:

The company is one of the 20 largest pharmaceutical companies in the world and operates in 16 European countries. With over 15,000 employees in 20 countries, the company develops and markets innovative medicines for patients in the field of hypertension, thrombotic diseases and in the field of oncology.

Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!

I look forward to your application!