Associate Director AS&T Manufacturing Network
About The Position
As Analytical Transfer Lead, you will play a pivotal role in advancing BioNTech's mission to develop cutting-edge therapies. As part of the Analytical Sciences and Technology (AS&T) team, you will be responsible for ensuring smooth analytical transfers within our manufacturing and testing network. Acting as the single point of contact (SPoC) for Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs), and internal sites, you will lead critical processes that facilitate innovation and operational excellence. Your work will directly contribute to the onboarding of new partners into BioNTech's network and support routine operations, helping us maintain our commitment to delivering high-quality therapies to patients worldwide.
Requirements
- Bachelor's degree in biology, chemistry, pharmacy, biotechnology, or a related field.
- 6 plus years of experience in a regulated environment within the biotechnology or pharmaceutical industry, ideally under GMP standards.
- Demonstrated expertise in leading analytical transfers including method implementation, optimization, troubleshooting, and validation
- Strong knowledge of therapeutic protein analytics (e.g., antibodies or ADCs), particularly in areas such as HPLC, bioassays, or ELISAs
- Exceptional organizational skills with an ability to manage multiple priorities effectively in a dynamic environment
- Detail-oriented mindset with strong problem-solving abilities
Nice To Haves
- Experience managing QC aspects at external partners like CMOs, familiarity with US, EU, EMA, and FDA regulatory standards.
- Advanced degree.
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
Benefits
- Medical, Dental and Vision Insurance
- Life, AD&D, Critical Illness Insurance
- Pre-tax HSA & FSA, DCRA Spending Accounts
- Employee Assistance & Concierge Program (EAP) available 24/7
- Parental and Childbirth Leave & Family Planning Assistance
- Sitterstream: Virtual Tutoring & Childcare Membership
- Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
- 401(K) Plan with Company Match
- Tuition Reimbursement & Student Loan Assistance Programs
- Wellbeing Incentive Platforms & Incentives
- Professional Development Programs
- Commuting Allowance and subsidized parking
- Discounted Home, Auto & Pet Insurance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
