CMC Senior Principal Scientist — Cell & Gene Therapy

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

Job summary

CSL Behring seeks a Principal Scientist, CMC to act as a senior SME guiding CMC activities for innovative biologics. You will lead strategy discussions across development, manufacturing, quality, regulatory, and external partners, shaping process and analytical development, characterization, and technology transfer.

You will drive data-driven recommendations, collaborate with cross-functional teams, and contribute to lifecycle management and risk mitigation while mentoring colleagues and

Qualifications

• 8+ years of CMC experience in biotech/pharma.
• Expert in cell and gene therapy platform development.
• Experience with external development and manufacturing partners.
• Strong scientific guidance and risk-based decision making.
• Familiarity with regulatory expectations across programs.

Responsibilities

• Apply deep CMC expertise to strategy discussions across development and manufacturing.
• Develop data-driven technical recommendations balancing timelines, quality, and risk.
• Provide oversight for external CDMOs/CROs and tech transfer activities.
• Collaborate with cross-functional teams to ensure technical considerations are communicated.
• Mentor colleagues and promote scientific rigor and continuous improvement.
• Support lifecycle management and change control across programs.

Skills

CMC expertise

Cell & gene therapy

Cross-functional collaboration

Process development

Analytical development

Regulatory knowledge

Lifecycle management

External partner engagement

Mentoring

Data-driven recommendations

Education

Advanced degree in a relevant scientific or engineering discipline

Bachelor’s degree with significant relevant industry experience

Job description

CSL Behring seeks a Principal Scientist, CMC to act as a senior SME guiding CMC activities for innovative biologics. You will lead strategy discussions across development, manufacturing, quality, regulatory, and external partners, shaping process and analytical development, characterization, and technology transfer.

You will drive data-driven recommendations, collaborate with cross-functional teams, and contribute to lifecycle management and risk mitigation while mentoring colleagues and