Senior Scientist I, Biologics Analytical R&D

Role Summary

Senior Scientist I, Biologics Analytical R&D. Support early-phase programs (Discovery through Phase I) with a focus on antibody–drug conjugates (ADCs) and potential emerging modalities (e.g., LNPs, siRNA). Collaborative environment with broad exposure across techniques, modalities, and development stages.

Responsibilities

• Method Development & Validation: Independently design, develop, and qualify robust analytical methods (e.g., HPLC, iCIEF, CE) to support drug substance and drug product characterization, reference material qualification, and early-phase validation.
• Testing & Data Generation: Execute GMP and non-GMP testing for release and stability; deliver comprehensive data packages that inform formulation, process development, and regulatory strategy.
• Cross-Functional Collaboration: Partner closely with Drug Substance (DS), Drug Product (DP), Regulatory Affairs, QA, and PDS&T to align analytical strategy with program needs.
• Scientific Leadership: Anticipate challenges, critically evaluate new technologies, and champion innovative solutions that accelerate program progress.
• Knowledge Sharing: Author technical reports, regulatory documents, and publications; contribute to building reference standards, product control strategies, and IND/CTA submissions.
• Mentorship & Growth: Contribute to a collaborative lab environment, with opportunities to mentor junior scientists and expand expertise across multiple analytical platforms.

Qualifications

• Degree in Analytical Development, Chemistry, Biochemistry, Biology, or related discipline: BS with 10+ years industry experience, MS with 8+ years industry experience, or PhD with limited to 0 years‚Äô industry experience (new graduates considered) with relevant laboratory experience.
• Strong background in protein/biologics analytical characterization, particularly HPLC and capillary electrophoresis methods.
• Experience in method development and validation; familiarity with GMP expectations for early-phase programs.
• Demonstrated ability to work independently, manage multiple projects, and drive deliverables to completion in a fast-paced environment.
• Strong interpersonal and communication skills with a track record of cross-functional collaboration.
• Supervisory or mentoring experience preferred but not required.

Skills

• Analytical method development and validation
• HPLC, iCIEF, CE, and other protein/biologics characterization techniques
• GMP and non-GMP testing for release and stability
• Data analysis, interpretation, and reporting
• Cross-functional collaboration and communication

Education

• BS/MS/PhD in Analytical Development, Chemistry, Biochemistry, Biology, or related field (as specified in qualifications)