Senior Scientist, Physicochemical Analytics

Job title: Senior Scientist, Physicochemical Analytics

About the Role BioNTech is seeking a Senior Scientist, Physicochemical Analytics to provide technical analytical expertise for GMP-compliant physicochemical investigations, lead technology transfer projects, and support routine production. The role also supports product development and regulatory submissions, acts as SME for regulatory filings, and contributes to SOPs and the adoption of new analytical technologies.

What You'll Do

• Provide technical analytical expertise and guidance on GMP physicochemical laboratory investigations.
• 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 during technology transfer and routine production.
• Support troubleshooting and continuous improvement in the physicochemical laboratory; support inspections and quality audits.
• Support ongoing product development and regulatory submissions for our Protein-based therapeutic pipeline; act as physicochemical analytical SME with expert knowledge to regulatory filings and questions from health authorities.
• Participate in the creation/revision and approval of AS&T-owned Standard Operating Procedures, work instructions, technical documentation package and other supporting documents.
• Support the evaluation and implementation of new physicochemical technologies required to maintain state-of-the-art analytical methods for development in alignment with internal and external stakeholders.
• Establish physicochemical analytical methods.
• Establish a physicochemical platform methods with reference to the pharmacopoeia of various countries and regulatory guidance.
• Complete other tasks assigned by the leader.

What We're Looking For

• Bachelor degree or above, major in biochemistry, bioanalysis, analytical chemistry and other related majors.
• More than 4 years of relevant work experience in GMP biopharmaceutical enterprises.
• Rich experience in analysis and quality control in the pharmaceutical industry; Experience in physicochemical methods including but not limited to various HPLC- and capillary-based analytical methods.
• Familiar with the global regulations for quality control and have certain understanding of GMP requirements.
• Familiar with the relevant instruments, method developments and method validations of biologics.
• Strong independent thinking and analytical skills, able to provide solutions according to the actual situation.
• Good project management ability, good communication skills, and good team spirit.
• Good English listening, speaking, reading and writing skills.