Senior Scientist II, Analytical Development
Gaithersburg, US | full time | Job ID: 10735
About the Role:
As a Senior Scientist II, Analytical Development, you will play a pivotal role in advancing BioNTech's mission to revolutionize healthcare through innovative antibody and ADC products. You will be part of a dynamic, lab-based team, driving technical excellence in LC-MS method development and characterization while contributing to regulatory strategies and submissions. Your expertise will directly support our goal of delivering high-quality therapies to patients worldwide.
In this role, you will thrive in a fast-paced environment where ambiguity is an opportunity. Your ability to distill complex data into actionable insights will be instrumental in shaping analytical strategies and ensuring compliance with regulatory standards. Join us and make a meaningful impact on cutting-edge biopharmaceutical development.
Your Contribution:
Develop and execute phase-appropriate LC-MS strategies across early and late development stages, including BLA-enabling activities
Identify analytical risks and gaps; design mitigation plans and study strategies such as comparability, stability, characterization, and investigations
Mentor scientists in LC-MS fundamentals, fostering scientific rigor and continuous improvement within the team
Define and refine internal workflows and best practices for analytical development in high-impact environments
Lead optimization and qualification of LC-MS assays across platforms (e.g., intact mass, peptide mapping, released glycan analysis)
Implement Multi-Attribute Methods (MAM) for antibody characterization, QC support, comparability studies, and change control
Requirements:
PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with relevant post-doctoral and 8 plus years industry experience; alternatively MS with substantial industry experience
Hands-on expertise in LC-MS method development, qualification/validation, transfer processes; global experience (e.g China and/or global partners) is advantageous
Strong background in biologics CMC principles including ICH Q6b standards, PPQ/BLA readiness, analytical control strategies, and specification setting
Experience developing characterization methods for antibodies (e.g., glycans analysis) using diverse ionization modes preferred
Proven track record as a technical leader within cross-functional teams in dynamic environments
Open-minded approach to ambiguity; ability to create structured solutions where none exist
Prefered requirements: 7 plus years in global pharma AD and/or AS&T for monoclonal antibodies or related biologics; late-stage / BLA experience. Hands-on expertise in LC-MS method development, qualification/validation, transfer processes; global experience (e.g China and/or global partners) is advantageous
US based candidates expected Pay Range: $130,800 - $209,400/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.
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.