Senior CMC Scientist - Cell & Gene Therapy

CSL; Waltham (MA); Remote; USD 179,000 - 212,000; Full time

Job summary

CSL is seeking a Principal Scientist, CMC to act as a senior scientific expert, guiding Chemistry, Manufacturing and Controls for innovative biologics. The role spans process and analytical development, tech transfer, and lifecycle management, with emphasis on cell and gene therapies and advanced modalities.

The candidate will influence external partners, drive risk-based decisions, and lead cross-functional collaboration to ensure regulatory readiness and product quality across development and

Qualifications

• Advanced degree preferred; Bachelor’s with significant experience considered.
• Deep CMC knowledge across product and process development.
• Experience with cell and gene therapy and/or other advanced modalities a plus.

Responsibilities

• Provide expert CMC guidance and risk-based recommendations for programs.
• Develop data-driven, fit-for-purpose technical approaches balancing regulatory, quality, supply, and timelines.
• Serve as SME for cell and gene therapy platforms; familiarity with AAV or other vectors is a plus.
• Provide technical input and oversight for external CDMOs, CROs, and technology providers; support scope definition and issue resolution.
• Collaborate with Process Development, Analytical Development, Quality, Regulatory, Manufacturing, Supply Chain and Clinical teams to ensure clear communication of technical considerations.
• Share platform knowledge, advance scientific standards, mentor colleagues, and promote continuous improvement.

Skills

CMC strategy

Cross-functional leadership

Cell & gene therapy

Technical risk assessment

Process development

Analytical development

External partnerships

Education

Advanced degree in science/engineering

Bachelor’s degree with significant industry experience

Job description

CSL is seeking a Principal Scientist, CMC to act as a senior scientific expert, guiding Chemistry, Manufacturing and Controls for innovative biologics. The role spans process and analytical development, tech transfer, and lifecycle management, with emphasis on cell and gene therapies and advanced modalities.

The candidate will influence external partners, drive risk-based decisions, and lead cross-functional collaboration to ensure regulatory readiness and product quality across development and