Senior Scientist I, Analytical Development
Gaithersburg, US | Full time
About the Role
As a Senior Scientist I in Analytical Development at BioNTech, you will play a critical role in advancing our mission to revolutionize medicine. You will be part of a lean, laboratory-based team dedicated to supporting antibodies and ADC products. In this hands-on position, you will lead analytical method development, optimization, and lifecycle activities while contributing to the broader analytical and CMC strategies. This role offers an opportunity to work collaboratively across teams, tackle complex challenges, and directly impact the development of cutting-edge biologics programs.
Responsibilities
- Perform hands-on laboratory activities for method development, optimization, troubleshooting, and phase-appropriate assay support for biologics such as antibodies and ADCs
- Generate, analyze, interpret, and document high-quality data packages to support product development, comparability studies, method transfer readiness, and late-stage program needs
- Support analytical method lifecycle activities including qualification/validation readiness and assay performance evaluation
- Contribute to technical documentation such as protocols, reports, study summaries, and CMC-related sections of regulatory submissions
- Collaborate cross-functionally with internal teams and external partners to enhance laboratory execution, data review processes, and continuous improvement initiatives
Requirements
- PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related discipline with 6+ years of relevant experience (post-doctoral training included), or MS with 8+ years of industry experience
- Expertise in analytical development for biopharmaceuticals (antibodies/ADCs)
- Strong background in developing physiochemical methods such as HPLC, icIEF, CE-SDS as well as extended characterization techniques
- Working knowledge of biologics CMC expectations including analytical control strategies and specification support
- Proven ability to work effectively within cross-functional teams in dynamic development environments
- Strong skills in data analysis, technical writing, and problem-solving; willingness to travel both domestically and internationally
Preferred Qualifications
- BLA-enabling extended characterization experience and experience in late-stage/BLA projects
Pay
Expected Pay Range: $113,600/year to $181,600/year + annual bonus & equity (bonus and equity are 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.
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
About the Location
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.