ASAT Physicochemical Manager

Responsibilities

• Lead the physicochemical quality control team in establishing analytical methods and platforms based on global pharmacopoeias.
• Oversee analytical method transfer projects and provide technical support to CMOs and new manufacturing sites during introduction and routine production.
• Act as a Subject Matter Expert (SME) for regulatory filings (BLA/MAA) and respond to health authority inquiries.
• Provide technical expertise for laboratory investigations, customer complaints, and troubleshooting activities.
• Manage the transfer of non-pharmacopoeial methods developed by the method development department and organize validation activities.
• Support the creation, revision, and approval of SOPs, work instructions, and technical documentation.
• Evaluate and implement new technologies to ensure analytical methods remain state-of-the-art.
• Support the onboarding of new team members and facilitate effective communication within the production environment.

Requirements

• Bachelor's degree or above in Biochemistry, Bioanalysis, Analytical Chemistry, or a related field.
• 7+ years of relevant experience within a GMP biopharmaceutical company.
• Extensive experience in analytical quality control, specifically with HPLC and CE method validation.
• Deep understanding of global pharmaceutical regulations, including ICH, NMPA, FDA, EMA, USP, ChP, and EP.
• Strong proficiency in biopharmaceutical quality control instrumentation and method development.
• Proven leadership and project management skills with the ability to solve complex problems independently.
• Excellent communication skills and fluency in English (written and spoken).
• Strong teamwork spirit and a high sense of responsibility.

About the Company

BioNTech is a leading biotechnology company pioneering novel therapies for patients. We focus on developing next-generation immunotherapies, including mRNA-based therapeutics, to treat cancer and other serious diseases.