Deputy Head of Production

Deputy Head of Production

MorphoSys

Planegg, Germany

Your Responsibilities

  • Implementation and oversight of Drug Substance and Drug Product Manufacturing process including authorization of master batch records, batch record review and risk assessments;
  • Handling of deviations, change control requests and complaints;
  • Support process validation and compilation of regulatory submissions (IND/IMPD/BLA);
  • Support implementation and maintenance of SOPs;
  • Supervision of process development and GMP manufacturing activities at external Contract Manufacturers and MorphoSys’ internal process development;
  • Selection of CMOs for Cell Line Generation, Drug Substance and Drug Product Manufacturing activities;
  • Provide scientific and strategic input for efficient preparation and execution of CMC development plans;
  • Closely collaborate with internal and external project teams and ensure seamless supply of high quality material for clinical studies;
  • Represent your area of responsibility across functions and departments, at CMOs and collaboration partners;
  • Report to the Head of Production/Head of CMC.

Your Requirements

  • University Degree in Biotechnology, Biology, or Pharmacy, combined with several years of relevant industry experience;
  • Proven track record in process development and GMP manufacturing of biologicals (preferably antibodies) for clinical trial supply (Phase I – pivotal phase);
  • Sound knowledge of the pharmaceutical laws (AMG, AMWHV), regulatory guidelines and GMP requirements;
  • Deep understanding of pharmaceutical production and analytical testing of biotechnological products;
  • Team player with highly structured approach and well developed communication skills;
  • Excellent command of English and German both written and spoken;
  • Initiative, confidence and flexibility.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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