22 days ago on jobs.jnj.com

Principal Scientist / Senior Manager

Crucell Switzerland AG

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Principal Scientist / Senior Manager

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Principal Scientist / Senior Manager

Standorte:Bern, Schweiz
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Requisition ID: 0000179C

Janssen Vaccines AG, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide.


The Bern site acts as a center of expertise for development and manufacturing of innovative cell based viral- and bacterial vaccines products and is recently expanding its portfolio into the area of bacterial based therapeutic products

For our site in Berne we are looking for a highly committed

Principal Scientist / Senior Manager
Your main tasks will be:
  • Leading & coaching a team of senior scientists and project managers engaged in new product development, scale-up, tech transfer and product implementation of vaccines and bacterial therapeutics at clinical and commercial stage
  • Providing scientific direction, technical guidance and relevant training to USP, DSP and Analytical Subject Matter Experts (technical integrators) in line with the CMC project strategy and consistent with best practices in the development and commercial network
  • Overseeing & managing  USP & DSP laboratory operations and related infrastructure
  • Supporting the development teams in reliable scale-down, scale-up modeling, technology transfer and validation activities with an economic and robust manufacturing and release testing in mind
  • Providing a lean and compliant data management structure ensuring scientific quality and integrity of development data
  • Supporting the technology transfer activities between sending and receiving parties in the internal and external manufacturing network  
  • Reviewing and evaluation of critical development and submission protocols (IND, IMPD, BLA, MAA) to ensure activities comply with industry, company and regulatory expectations for safety, efficacy and compatibility with standard clinical practice
  • Defining and driving a continuous improvement and knowledge sharing culture in analytical and process development and in new product implementation strategies
  • Presenting programs at senior management meetings and actively engaging as Subject Matter Expert (SME) in the scientific and bioengineering community.  

  • Master degree or Ph.D in Biotechnology / Biology / Biochemistry / Process engineering
  • Team player and a personality with excellent interpersonal communication skills and people management capabilities  
  • Strong technical and scientific background paired with several years of practical industry experience in development, characterisation, scale-up and launch of biomolecules, preferably vaccines. Experience in Fill & Finish is an asset
  • Strong background in DoE/Process excellence and investigation tools; Green or black belt certification is an asset
  • Solid project management experience    
  • Excellent problem solving and analytical capabilities
  • Capacity to communicate fluently in English and German
  • Ability to partner cross-functionally with CMC, Project Management, Quality and Regulatory and with the line functions in the development organisations across sites

We are offering you a multifacetted challenge in a dynamic, international environment with attractive terms. Welcome to join us for making together a difference to peoples health? Please send us your online application (CV, Working References etc.).

Primärer Standort
Crucell Switzerland AG (8851)