Senior Scientist, Analytical Development (AD)

Role Summary

We are seeking a highly motivated Senior Scientist to join the Potency and Functional Characterization team within Analytical Development. This role will focus on design, development, and validation of cell-based and ligand-binding assays to support the characterization, release, and stability testing of biologics. The ideal candidate will have deep expertise in bioassay development and strong analytical skills. This is a lab-based role, and the selected candidate will collaborate effectively within cross-functional teams, including colleagues from Research, Quality Control, Process Development, Drug Product Development, and Regulatory Affairs to drive alignment on potency strategy and successful transfer to Quality Control environments.

The successful candidate will stay abreast of emerging technologies, industry trends, and regulatory expectations. This role will actively drive innovation by evaluating and implementing novel analytical approaches, automation solutions, and digital tools to enhance method performance, efficiency, and data trending. Expertise in the generation and/or use of analytical cell lines with stable expression of targets of interest and/or reporter constructs to enable measurement of signal transduction is preferred.

Responsibilities

• Develop and optimize cell-based functional assays and ligand-binding assays for potency determination of protein therapeutics.
• Define potency strategy and method design based on clinically relevant mechanisms of action (MoA), targeted method performance, and transferability.
• Apply deep knowledge of regulatory guidelines (ICH, USP chapters) to ensure compliance in bioassay development and validation.
• Independently resolve complex technical challenges and implement innovative solutions.
• Provide sole technical leadership within assigned programs and offer guidance across other programs as needed.
• Serve as a technical resource and mentor, training colleagues across multiple technologies.
• Stay current with emerging technologies, industry trends, and regulatory expectations related to potency methods for biologics.
• Review, interpret, and communicate complex data clearly to functional leadership and cross-functional teams.
• Lead technology transfer activities internally and externally, building and maintaining key vendor relationships.
• Develop project strategies within Analytical Development and across functions, guiding team members to successful execution.
• Author technical reports, regulatory filing sections, and scientific publications as appropriate.
• Effectively manage multiple programs and represent Analytical Development on project teams

Qualifications

• Bachelors degree with 10+ yrs relevant experience, Masters degree with 8+ yrs relevant experience, Ph.D. with 2+ yr relevant experience
• Demonstrated expertise in the development, validation, and lifecycle management of cell-based potency assays, including experience with relevant techniques and technologies.
• Robust understanding of regulatory guidance and industry standards relevant to analytical CMC activities, particularly in the development and validation of potency assays
• Demonstrated ability to communicate complex data clearly and concisely, with excellent scientific writing skills, strong attention to detail, and a proven track record of effective cross-functional collaboration.

Education

• Bachelors degree with 10+ yrs relevant experience; Masters degree with 8+ yrs relevant experience; Ph.D. with 2+ yrs relevant experience

Skills

• Cell-based potency assay development and validation
• Regulatory knowledge (ICH, USP) for analytical CMC
• Data interpretation and scientific communication
• Cross-functional collaboration and mentorship
• Technology transfer and vendor management