Associate Director AS&T Manufacturing Network

Role Summary

Associate Director AS&T Manufacturing Network in Gaithersburg, US. Analytical Transfer Lead (AS&T) contributes to the development of the product pipeline as part of the Analytical Sciences and Technology team. Serves as the main contact for analytical transfers at CMOs, CTOs, and internal sites, and leads analytical transfers and onboarding into the BioNTech manufacturing and testing network, along with supporting routine operations.

Responsibilities

• Defining, maintaining, and facilitating the communication line between internal departments and sites and external collaboration partners and CMOs; supporting compliance and harmonization of analytical testing strategies as the main contact of CMOs/new sites during onboarding and/or transfer
• Leading analytical technology transfer projects in the internal and external manufacturing network
• Conducting analytical investigations and problem-solving activities during technology transfer and routine production
• Overseeing the creation, revision, and approval of work instructions, transfer/validation documentation and other supporting documents
• Supporting the evaluation and implementation of new technologies required to maintain state-of-the-art analytical methods for development in alignment with internal and external stakeholders
• Providing support for troubleshooting and continuous improvement in the laboratory

Qualifications

• Required: University degree in biology, chemistry, pharmacy, biotechnology or comparable OR advanced degree in life science or healthcare (or equivalent)
• Required: Several years of working experience in a regulated environment in Biotechnology or Pharmaceutical Industry, ideally under GMP, with knowledge of standard quality processes (OOS, deviations, Change control, CAPAs)
• Required: Experience in leading analytical transfers covering method implementation, optimization, troubleshooting and validation, ideally in QC within the pharmaceutical industry
• Required: Knowledge in analytics of therapeutic proteins (e.g., antibodies, ADCs), especially analytical chemistry (e.g., HPLC), bioassays and/or ELISAs
• Required: Excellent organizational skills, ability to manage multiple priorities and deliver results in a fast-paced environment
• Required: Highly conscientious, detail-oriented, and problem-solving approach
• Required: Effective communication skills (verbal and written), supportive team player, and excellent collaboration and stakeholder management
• Preferred: Experience in managing analytical/QC aspects at external partners (CMOs)
• Preferred: Knowledge of relevant US, EU, EMA and FDA regulatory standards

Education

• Not specified beyond degree requirements above