Proclinical Staffing

Senior Manager Upstream Process Development

07 May 2021
21 May 2021
Alex Bero
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Proclinical is currently recruiting for a Senior Scientist, Upstream Process Development for an exciting and rapidly growing biotech company near Switzerland. As the Senior Scientist Upstream Process Development, you will be play a leading role on upstream process development; scale up, and technical support of cGMP manufacturing and be responsible for generating materials for pre-clinical studies and other development purposes.

Job Responsibilities

  • Oversee and guide in sourced (USP laboratory) and outsourced (CDO, CMO) upstream activities around the technical development of a Biosimilar; including, upstream process development and generation of drug product, clinical trial supply, process characterisation and validation and submission of CMC documents
  • Strategically define the technical corridor for analytical similarity to be achieved when developing biosimilar products
  • Review and approve external protocols / reports and other documents
  • Assume a leading role in the planning and execution of USP tech transfer activities for handover and scale up of projects to external GMP manufacturing sites
  • 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 Drive issue resolution in order to achieve Biosimilarity within the pre-defined analytical similarity corridor
  • Provide scientific and technical operational guidance for the upstream process development activities to the Biosimilars Development Teams and the Biosimilar Leadership Team
  • Provide technical and scientific oversight of licensed upstream processes to ensure consistency of supply
  • Prepare and review (when appropriate) the CMC section of the regulatory dossier
  • Serve as the technical operational upstream expert for regulatory consultations/interactions; including briefing book and dossier creation and question response
  • Represent Upstream Process Development at cross functional meetings
  • Coach, mentor and provide technical guidance to scientists and technicians

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 5 years' experience in Pharma/Biotech/Biosimilars Industry with demonstrated track record in Upstream processing for biologics
  • Strong technical and scientific expertise across the Upstream development spectrum including process development, scale up, tech transfer, process characterization and large scale manufacturing Technical leadership and influencing skills
  • Ability to critically evaluate scientific data obtained at different stages of development

To Apply

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