CMC Senior Principal Scientist - Cell & Gene Therapy

CSL Ltd. ADR; United States; Remote; USD 179,000 - 212,000; Full time

Job summary

CSL Behring is seeking a Principal Scientist, CMC to act as a senior scientific SME for Chemistry, Manufacturing and Controls supporting innovative biologics. The role provides expert technical assessment, guidance, and risk-based recommendations to program teams spanning Development, Technical Operations, Quality, Regulatory, Clinical Development, Supply Chain, and external partners.

Deep CMC expertise in cell/gene therapy is required.

Qualifications

• Deep CMC expertise across biologics, with emphasis on cell and gene therapy.
• Experience in process, analytical development and characterization, scalable manufacturing and tech transfer.

Responsibilities

• Provide expert CMC input for strategy discussions across development, operations, quality, regulatory and supply chain.
• Guide risk-based recommendations balancing science, regulatory expectations, quality, and timelines.
• Mentor teams and contribute to advancement of platform knowledge and best practices.

Skills

CMC expertise

cell therapy

gene therapy

process development

analytical development

characterization

manufacturing

technology transfer

stability

control strategy

lifecycle management

external partnerships

Education

Advanced degree in a relevant scientific/engineering discipline

Bachelor’s degree with significant relevant industry experience

Job description

CSL Behring is seeking a Principal Scientist, CMC to act as a senior scientific SME for Chemistry, Manufacturing and Controls supporting innovative biologics. The role provides expert technical assessment, guidance, and risk-based recommendations to program teams spanning Development, Technical Operations, Quality, Regulatory, Clinical Development, Supply Chain, and external partners.

Deep CMC expertise in cell/gene therapy is required.