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