Scientist* Early Stage Formulation Process Development (CMC)
BioNTech
Mainz
vor 6 Tg.

Scientist* Early Stage Formulation Process Development (CMC)

As part of the CMC Formulation Process Development team, you will contribute to the design and execution of CMC studies to contribute to technical reports for regulatory filing.

Your main responsibilities are :

  • Process engineering and technical oversight for the team; planning, execution and reporting (including official reports to external partners or authorities) of numerous types of CMC laboratory experimental studies (e.
  • g. in use stability, process compatibility and bridging etc.)

  • Acting as the SME for processes introduced into BioNTech
  • Contributing to technical documentation for regulatory filling
  • Coordination and management (incl. self-responsible contacting manufacturers, CMOs, CROs etc.) of activities related to the material logistics, supply and inventory management for various CMC experiments and scenarios
  • Responsibility for instruments, laboratory management and supervision of Student Assistants and Research Associates
  • Independent and autonomous data processing, evaluation, documentation of experiments, and writing of reports (internal & official reports)
  • liaising with various departments and external partners to devise experimental plans and strategies to serve the CMC sections of Regulatory documents
  • What you have to offer.

  • PhD in a relevant scientific area
  • Experience in process design for formulation development gained in a pharmaceutical or biotech environment
  • Knowledge of the regulatory documentation process for drug development
  • Hands on experience with regulatory fillings is preferable
  • A multi-disciplinary background gained through working in analytical and pre-clinical development departments is preferable
  • Strong planning expertise and a quality oriented approach to report writing
  • Coordination and management of internal and external partners
  • Some experience in laboratory management and supervision of Student Assistants and Research Associates
  • Fluency in English both written and spoken is a requirement
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