Senior Scientist I, Analytical Development (Gaithersburg, MD, US, MD 20878)

Biopharma Careers; Gaithersburg (MD); On-site; USD 114,000 - 182,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

401(K) Plan with Company Match

Tuition Reimbursement

Flexible Paid Time Off

Job summary

BioNTech in Gaithersburg, MD is seeking a Senior Scientist I in Analytical Development to lead method development and lifecycle activities for biologics such as antibodies and ADCs. This hands-on role involves developing robust analytical strategies and collaborating across teams to support CMC objectives.

You will perform lab work, analyze data, and prepare documentation for regulatory submissions, contributing to fast-paced development programs and continuous improvement efforts.

Qualifications

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related discipline with 6+ years of industry experience.
• Expertise in analytical development for biopharmaceuticals (antibodies/ADCs).
• Strong data analysis and technical writing skills; willingness to travel domestically and internationally.
• Preferred: BLA-enabling extended characterization and late-stage project experience.

Responsibilities

• Lead hands-on method development, optimization, troubleshooting for biologics such as antibodies and ADCs.
• Generate and document data packages to support product development and regulatory readiness.
• Contribute to lifecycle activities and regulatory submission documentation.
• Collaborate cross-functionally to improve laboratory execution and data review.

Skills

Analytical development

Biopharma expertise

Data analysis

Technical writing

Travel willingness

Education

PhD in Analytical Chemistry

Tools

HPLC

icIEF

CE-SDS

Job description

Gaithersburg, US | full time | Job ID: 11682

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.

Your Contribution:

• 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

A Good Match:

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related discipline with 6 plus 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, problem-solving; willingness to travel both domestically and internationally
• Preferred Requirements: BLA-enabling extended characterization experience and experience in late-stage/BLA projects

Your benefits and remuneration:

Expected Pay Range: $113,600/year to $181,600/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.

• 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.

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.