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CMC Process Expert (Biotechnology) - 50%

Coopers Group GmbH

Posted on Mar 16, 2021 by Coopers Group GmbH

Basel, Switzerland
Health Care
Immediate Start
Annual Salary

For our Pharma client in Basel, we are looking for a

CMC Process Expert (Biotechnology) - 50%

Start/Ende:ASAP - 12 months

Main tasks:

  • Maintain (author, update and review) Common Technical Documents (CTD) and technical protocols, reports and technology transfer documents for regulatory submissions, eg CMC changes/variations, post-approval change management protocols and for marketing licensure applications (MAAs/BLAs)
  • Setup and maintain CMC changes in the data base, perform CMC applicant assessments and drive and support the CMC Change Management Process to ensure a continuous and complaint commercial supply - Provide ongoing technical support for deviation investigations and CAPA management as required during development and commercial manufacturing of products
  • Assess suitability of documentation provided by Contract Manufacturer Organizations (CMO) to reflect the information adequately in the registration dossier sections impacted by the change(s).
  • As applicant: transfer of external change requests to the internal change management system, preparing the change application in such a way that it is understood by all relevant functions (regulatory, quality, supply chain, etc).
  • Evaluate the impact of the change (GMP and/or regulatory relevant)
  • Ad hoc preparation of answers to questions from health authorities
  • Support technology transfer from process development to cGMP manufacturing and site transfers of commercial manufacturing processes as required meeting global demand forecasts
  • Ensure, product and project timelines, costs and quality are maintained
  • Focus on cGMP production for market supply Help to improve workflows and business processes

Qualifications and experience required:

  • Degree in Life Science or equivalent with experience in support of CMC, start-up, tech transfer, and/or sustaining cGMP commercial drug substance manufacturing process operations in biopharmaceuticals and/or an equivalent combination of education and experience
  • Demonstrated experience in biotech manufacturing especially with large scale bio-reactors & purification or demonstrated experience/technical knowledge with drug product manufacturing is required (ie Formulation, aseptic filling, lyophilization)
  • Knowledge of ICH guidelines and cGMP regulatory guidelines for EU and USA
  • Profound experience in preparation and management of CMC documents
  • Experience in external manufacturing of biologics
  • Able to effectively manage multiple projects, deadlines and priorities simultaneously
  • Proficient with Microsoft applications
  • Strong interpersonal skills, excellent organizer
  • Fluent in English is a must. German, French and Spanish are an asset
  • Flexibility to adapt to a fast moving and international environment
  • Team player, task oriented and keen on working in a cross-cultural environment

Reference: 1129585747

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