Senior Scientist, Analytical Development (AD)

Role Summary

Senior Scientist, Analytical Development (AD) role focusing on design, development, and validation of cell-based and ligand-binding assays to support characterization, release, and stability testing of biologics. Collaboration across Research, Quality Control, Process Development, Drug Product Development, and Regulatory Affairs to align potency strategy and transfer to Quality Control environments. Emphasis on innovation, emerging technologies, and regulatory expectations in potency methods for biologics.

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

• Education: 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.

Skills

• Bioassay development, cell-based potency assays, ligand-binding assays
• Regulatory knowledge (ICH, USP) relevant to analytical CMC
• Data interpretation and clear communication to leadership and cross-functional teams
• Technology transfer and vendor relationship management

Education

• Advanced degree in a relevant science field (as per qualifications above)

Additional Requirements

• Location: Lexington, MA