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Senior Principal CMC Scientist

Posted 3 days ago

cslWaltham (MA)

SENIORITY

Manager

SALARY

$160000 - 220000 per year

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About the role

Serves as a senior scientific expert guiding CMC strategy for innovative biologics, especially cell and gene therapies. Provides technical recommendations across process and analytical development, manufacturing, technology transfer, stability, regulatory and quality considerations, and lifecycle management while collaborating with internal teams and external partners. Guide CMC strategy for innovative biologics and advanced therapeutic programs. Assess process development, analytical development, characterization, manufacturing, technology transfer, stability, control strategy, and lifecycle management. Develop data-driven technical recommendations aligned with program stage, scientific evidence, regulatory expectations, quality requirements, and supply needs. Provide technical oversight of external development and manufacturing partners, including review of deliverables, issue investigations, and risk mitigation. Contribute scientific expertise to cross-functional program teams and communicate technical considerations across functions. Share platform knowledge, develop best practices, mentor colleagues, and promote continuous improvement. CMC strategy Cell and gene therapy platforms Cell-based therapeutics Biologics process development Analytical development Manufacturing process characterization Technology transfer Stability and control strategy External partner technical oversight Process improvement

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