Senior Scientist II, Analytical Development Full-time

Senior Scientist II, Analytical Development

Gaithersburg, US | full time | Job ID: 10735

About the Role:

As a Senior Scientist II in 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 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

A Good Match:

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field with 8+ years relevant 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)
• 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.
• 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

Preferred Qualifications: 7 plus years in global pharma AD and/or AS&T for monoclonal antibodies or related biologics; late-stage/BLA experience

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.

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.

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BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

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