Lead the implementation and administration of the Pharmaceutical Quality System (PQS) and electronic Quality Management System (eQMS) to support growth from startup to commercial operations. Manage internal audits, regulatory inspections, and ensure alignment between internal quality requirements and external CDMO activities.
Syncromune
6 Remote Job Openings at Syncromune
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
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Full Time
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7 days 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.
Oversee the installation, maintenance, and functioning of combination product medical devices at oncology clinical trial sites. Provide technical guidance and training to site staff while troubleshooting equipment issues to ensure seamless trial operations.
Lead the design and execution of global regulatory strategies for oncology drug development programs from preclinical stages through BLA submission. Serve as a strategic partner to executive leadership and the primary liaison with health authorities like the FDA and EMA.
Lead the design and execution of global regulatory strategies for drug development programs from IND-enabling activities through BLA submission. Serve as a strategic partner to executive leadership and the primary contact for health authorities like the FDA and EMA.