Associate Director AS&T Manufacturing Network

Role Summary

Based in Gaithersburg, MD, the Associate Director AS&T Manufacturing Network serves as the Analytical Transfer Lead within BioNTech's Analytical Sciences and Technology (AS&T) team. You will be responsible for ensuring smooth analytical transfers across the manufacturing and testing network, acting as the single point of contact (SPoC) for Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs), and internal sites, leading critical processes that enable innovation and operational excellence. Your work will contribute to onboarding new partners into BioNTech's network and support routine operations to deliver high-quality therapies to patients worldwide.

Responsibilities

• Define, maintain, and facilitate communication between internal teams, external partners, and CMOs to ensure compliance and harmonization of analytical testing strategies
• Lead analytical technology transfer projects across BioNTech’s internal and external manufacturing network
• Conduct analytical investigations and problem-solving activities during technology transfers and routine production
• Oversee the creation, revision, and approval of work instructions, transfer/validation documentation, and other supporting materials
• Support the evaluation and implementation of state-of-the-art technologies for maintaining advanced analytical methods in collaboration with stakeholders
• Provide troubleshooting support and drive continuous improvement initiatives in laboratory settings

Qualifications

• Required: Bachelor's degree in biology, chemistry, pharmacy, biotechnology, or a related field; 6+ years of experience in a regulated environment within the biotechnology or pharmaceutical industry, ideally under GMP standards.
• Required: Demonstrated expertise in leading analytical transfers including method implementation, optimization, troubleshooting, and validation
• Required: Strong knowledge of therapeutic protein analytics (e.g., antibodies or ADCs), particularly in areas such as HPLC, bioassays, or ELISAs
• Required: Exceptional organizational skills with an ability to manage multiple priorities effectively in a dynamic environment
• Required: Detail-oriented mindset with strong problem-solving abilities
• Preferred: Experience managing QC aspects at external partners like CMOs, familiarity with US, EU, EMA, and FDA regulatory standards
• Preferred: Advanced degree

Skills

• Analytical technology transfer
• Analytical method development, validation, and troubleshooting
• HPLC, bioassays, ELISAs (therapeutic protein analytics)
• Documentation, SOPs, work instructions, transfer/validation documentation
• Project management and cross-functional collaboration
• Strong problem-solving and organizational abilities