The Associate Director leads the drug product development strategy for biologics, overseeing formulation, process characterization, and GMP manufacturing through external CDMO partners. This role ensures regulatory compliance and technical excellence by collaborating with cross-functional teams to advance candidates from clinical development to commercialization.
Syncromune
4 Remote Job Openings at Syncromune
Associate Director/Director, CMC Analytical Development, Separation
Syncromune
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Full Time
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25 days ago
Syncromune
Oversee the analytical strategy for drug substance and drug product development from early clinical phases through commercialization. Lead method development, validation, and transfer while managing external CDMO and CTL resources.
Provide strategic and operational leadership for analytical development and quality control activities supporting late-phase drug substance and product development. Oversee method development, validation, and lifecycle management while managing internal teams and external partners like CROs and CMOs.
Associate Director, CMC Analytical Development, Separation
Syncromune
·
Full Time
·
2 months ago
Syncromune
Oversee the analytical strategy for drug substance and drug product development from clinical phases through commercialization. Lead method development, validation, and transfer while managing external CDMO and CTL resources.