Director, Analytical Development

Gaithersburg, US   |   full time   |   Job ID: 11211 

About the Role:

As Director of Analytical Development, you will play a pivotal role in advancing BioNTech’s mission to revolutionize medicine. Your work will drive analytical strategy and execution for antibody and ADC programs, ensuring readiness for regulatory milestones such as BLA submissions. Partnering with cross-functional teams in Process Development, Global Technical Development, AS&T, Regulatory, and Quality, you will operate primarily in non-GMP laboratories to deliver impactful solutions that shape the future of biologics development.

This role offers an opportunity to lead innovative analytical strategies in a dynamic environment where your contributions will directly influence global regulatory submissions and product commercialization.

Your Contribution:

Collaborate with SMEs and GTD leads to develop robust methods, analytical control strategies, and seamless transfer packages
Proactively identify analytical risks and data gaps; design and implement risk mitigation studies (e.g., characterization, comparability, stability)
Establish internal best practices for phase-appropriate CMC hand-offs and analytical playbooks
Define CQAs and evolve associated control strategies across development phases aligned with ICH Q6B guidelines
Lead or contribute significantly to CMC documentation (IND/IMPDs, BLAs/MAAs) and technical responses related to analytics
Engage in hands-on laboratory work including method development, troubleshooting, and oversight of testing activities

A Good Match:

PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field with 10+ years of relevant experience; or MS with 12+ years of industry experience
Extensive expertise in global pharma AD/AS&T for monoclonal antibodies or ADCs; late-stage/BLA readiness experience preferred
Proven success leading BLA readiness/PPQ activities; commercial launch experience is a plus
Hands-on experience in biologics method development, qualification/validation, transfer processes; ADC-specific analytics knowledge desirable
Strong understanding of biologics CMC guidelines (ICH Q6B), analytical control strategies, specification setting & justification
Demonstrated leadership within matrixed environments; excellent communication skills
Global submission experience across regions (e.g., US/EU/China) is advantageous
Willingness to travel domestically/internationally based on program needs

If the position is filled in the US, the Expected Pay Range is $168,100/year to $268,700/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. Compensation at other locations may vary significantly.

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.