Senior Drug Substance Manager

Senior Drug Substance Manager

Ferring Pharmaceuticals

Copenhagen, Denmark

We are looking for a dynamic and recognized subject matter expert in the field of small molecule API manufacturing process development to join us as a Senior Drug Substance Manager. This position will be in the Chemical Development Department in Global Pharmaceutical R&D, Ferring. Chemical Development are getting ready for small molecule projects coming to us from our Research colleagues. Here is an exciting opportunity for you to combine your scientific skills within small molecule chemistry and your deep understanding of drug substance manufacturing process development with an interest in strategic work for shaping the future way of working of our department.

Main responsibilities:

As senior drug substance manager with focus on small molecules your main tasks are to:

  • Define the strategy for drug substance manufacturing process development;
  • Develop drug substance manufacturing processes and be responsible for drug substance manufacturing to support the development program until registration;
  • Lead activities related to the transfer of drug substance processes from Research to Development, and later from Development to Commercial manufacturing;
  • Evaluate and establish new external collaboration partners, including writing contracts and participating in on-site visits in collaboration with the Procurement Manager;
  • Define work-packages and deliverables for CMOs for external development activities and following up of the contractual agreements to ensure high scientific quality and timely finalization;
  • Develop and maintain good business relationships with CMOs and monitor their performance;
  • Coordinate process development activities performed in our laboratories together with lab technicians, scientists and subject matter experts;
  • Advance project defined deliverables including plans, budgets and status reports. Projects can be part of CMC, life-cycle management, or other feasibility projects;
  • Be member and report into the CMC project teams;
  • Represent Ferring in academic and scientific communities as well as with health authorities. Keep an updated scientific and regulatory knowledge in defined fields;
  • Regularly reporting, budgeting and forecasting and updating of Drug Substance project plan;
  • Compile and/or review of relevant project, regulatory and quality documents (including product specific Quality by Design documents);
  • Support specific department initiatives;
  • Writing/updating relevant SOPs;
  • Be responsible for observing that all relevant regulations and guidelines are adapted and followed and that work if performed according to safety and quality requirements (SOPs).

Qualifications

  • Minimum M. Sc. in chemical, and/or pharmaceutical sciences;
  • Ph.D. in synthetic chemistry is an asset;
  • Minimum 10 years’ experience in pharmaceutical industry;
  • Minimum 5 years’ experience in the drug substance manufacturing process development of small molecules;
  • Proven scientific skills and ability to do independent scientific work;
  • Proven project coordination/management skills with both internal and external stakeholders;
  • Experience in the pharmaceutical GXP regulated work;
  • English - Fluent in speaking and writing;
  • Keen on working in an international multicultural environment.

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© EuroJobsites 2022

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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