Product Developement Lead

Product Developement Lead

Catalent

Brussels, Belgium

For our sterile production site located in Belgium in Brussels (Neder-Over-Heembeek) which is currently expanding its capabilities, we are currently looking for a Biologic Product Development Lead, reporting to the Product Development Director.

The Biologic Product Development Lead is responsible for the development and implementation of downstream processing methodologies that can be easily transferred to the cGMP Manufacturing Team. Additionally, she/he supports other groups including Analytical Product Development, Process Development, and Project Management Office.

The Role

This position will perform a variety of laboratory procedures in Downstream Process Development, mainly focused on drug product formulation and supporting the other manufacturing steps as per need. The position will serve as a lead for technical advice and perform multiple complex projects at a time. This position is capable of working independently and without direction on assigned tasks/projects. This position plans and conducts work requiring independent judgment in the evaluation, selection, and substantial adaptation/modification of standard techniques, procedures, and criteria. This position designs new approaches to problems encountered and use a wide application of complex principles, theories, and concepts in the specific field.

  • Initiate, direct and execute scientific research for innovation and process improvements;
  • Responsible for the site Drug Product Development;
  • Be the site SME (Subject Matter Expert) for biological drug product development and support the site transition towards biological drug manufacturing;
  • Assist the project management team to determine timeframe, funding, and limitations;
  • Interact routinely with functional leaders at the site along with other Catalent sites to ensure alignment with processes and procedures;
  • Interact with BD (Business Development) team for the prospection of new business;
  • Act as a center of expertise for new biological drug development while interacting with customers;
  • Experience with quality control and quality control tracking systems including change control and deviations;
  • Supports internal and external audits.

The Candidate

  • Ph.D. in Biotechnology, or related field with at least 10 years of laboratory experience, preferably in an industrial setting or Master in Biotechnology or related field with at least 10 years of industry laboratory experience;
  • Fluency in English is mandatory and preferred in French;
  • Process scale experience for Biological drug product development including formulation development and drug product process development;
  • Operating, maintaining, and troubleshooting process skids preferably in an industrial setting;
  • Biological drug product formulation validation, process scale-up, and technology transfer;
  • Knowledge and experience working in a cGMP environment;
  • Good documentation practices (GDP);
  • Aseptic technique experience;
  • Experience writing standard operating procedures, batch records, and reports;
  • Experience mentoring staff regarding laboratory procedures and scientific projects.

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© EuroJobsites 2020

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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