Senior Manager Downstream Process Development

Swiss Franc140 - Swiss Franc141 per hour
  1. Permanent
  2. Bioprocessing
  3. Switzerland
Vaud, Switzerland
Posting date: 29 Apr 2021
37254

An exciting opportunity has arisen for a Senior Manager to oversee the Downstream Process Development. You will guide outsourced downstream activities around the technical development of a biosimilar. This role is based in Switzerland and is a fantastic opportunity to join a global company.

Job Responsibilities

  • Oversee and guide outsourced (CDO, CMO) downstream activities around the technical development of a Biosimilar
  • Assume a leading role in the planning and execution of DSP tech transfer activities for handover and scale up of projects to external GMP manufacturing sites
  • Review and approve external protocols / reports and other documents
  • Define technical development that follows the principles of Quality by Design (QbD) and specify activities, timelines, milestones and costs in collaboration with Global Manufacturing and Supply
  • Provide support to the analytics team to define the technical corridor for analytical similarity to be achieved when developing biosimilar products
  • Drive issue resolution for Downstream process in order to achieve analytical similarity within the pre-defined analytical similarity corridor; drive and support downstream troubleshooting and root-cause investigation activities at the CMO during development, GMP, PPQ and commercial campaigns
  • Provide scientific and technical guidance for the downstream process development activities for the in-house development labs and to the Biosimilars Development Teams and the Biosimilar Leadership Team
  • Provide technical and scientific oversight of licensed downstream processes to ensure consistency of supply
  • Prepare and review the CMC section of the regulatory dossier
  • Serve as the technical operational downstream expert for regulatory consultations/interactions; including briefing book and dossier creation and question response
  • Represent Downstream Process Development at cross functional meetings

Skills and Requirements

  • Masters in Science or Engineering, or BSc with added experience
  • Fluency in English essential, French and/or German would be an asset
  • Minimum 7 years' experience in Biotech/Biosimilars Industry with demonstrated track record in Downstream processing for biologics (specifically mammalian cell culture downstream)
  • Strong technical expertise across the Downstream development spectrum including process development, scale up, tech transfer, large scale manufacturing and process characterisation
  • Experience in evaluation and implementation of new technologies are desirable but not essential

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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