Associate Director AS&T Manufacturing Network

Gaithersburg, US   |   full time   |   Job ID: 9427 

As Analytical Transfer Lead (Associate Director AS&T Manufacturing Network), you will be making a meaningful contribution to the ongoing development of our product pipeline as part of the Analytical Sciences and Technology (AS&T) team. In this role, you will be the main contact (SPoC) for analytical transfers at Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs) and our internal sites. Furthermore, you will lead analytical transfers and the on-boarding into our BioNTech manufacturing- and testing- network, as well as the support of routine operations.

Your responsibilities: 

• Defining, maintaining, and facilitating the communication line between internal departments and sites and external collaboration partners and CMOs and supporting compliance and harmonization of analytical testing strategies as the main contact of CMOs/ new sites during on-boarding 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

What you have to offer: 

Essential Requirements

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

Desirable Requirements

• Experience in managing analytical/ QC aspects at external partners (CMOs)
• Knowledge of relevant US, EU, EMA and FDA regulatory standards

Your Benefits

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• 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

…and more! More details to be shared.
 

Located in the BioHealth Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation’s capital. The city’s strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg’s manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.

Apply now - We look forward to your application!

Apply for our Gaithersburg, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.