About this role
About the Role Join BioNTech as a Physicochemical Analytical Scientist responsible for leading GMP-compliant physicochemical investigations, technology transfer, and support across development, manufacturing, and regulatory submissions for protein-based therapeutics. What You'll Do
- Provide technical analytical expertise and guidance on physicochemical laboratory investigations with GMP standards and in accordance with relevant industry guidelines.
- Conduct physicochemical analytical technology transfer projects and support CMOs/new sites during onboarding, tech transfer, and routine production.
- Provide physicochemical analytical technical support and conduct problem-solving activities during technology transfer and routine production.
- Provide support for troubleshooting and continuous improvement in the physicochemical laboratory, and support inspections and quality audits.
- Support ongoing product development and regulatory submissions (BLA/MAA) for our protein-based therapeutic pipeline; act as a physicochemical analytical SME in regulatory filings and questions from health authorities.
- Participate in creation, revision, and approval of AS&T-owned SOPs, work instructions, technical documentation packages, and other supporting documents.
- Support evaluation and implementation of new physicochemical technologies to maintain state-of-the-art analytical methods in alignment with internal and external stakeholders.
- Establish physicochemical analytical methods and develop platform methods referencing pharmacopoeia and regulatory guidance.
- Complete other tasks as assigned by the leader.