Senior Scientist I, Analytical Development (Biologics)

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

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.