Vice President, Chemistry, Manufacturing and Controls (CMC)

Executive · Redwood City (onsite preferred; hybrid or remote considered)

Vice President, Chemistry, Manufacturing and Controls (CMC)

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Juvena is seeking a seasoned and strategic leader to join its executive team as Vice President of CMC. Reporting to the SVP of Drug Development, the Vice President defines and executes the CMC strategy for the portfolio from discovery through clinical-stage development, leads process development, analytical development and manufacturing, and guides novel candidates from lead optimization through regulatory filings, formulation, scale-up, clinical trials and commercialization.

The VP of CMC will oversee a primarily outsourced manufacturing model, building and managing strong relationships with a network of CDMOs, and will oversee internal small-scale production, protein engineering and lead-optimization activities for discovery and preclinical assets.

Key responsibilities

• Develop and execute a phase-appropriate CMC strategy across the pipeline, aligned with corporate objectives, program timelines and regulatory requirements.
• Lead drug-substance and drug-product activities: cell-line development, process development and optimization, scale-up and cGMP manufacturing.
• Provide technical leadership for formulation, fill/finish, drug devices such as pre-filled syringes, and analytical development including method validation and stability.
• Expertise in biologics manufacturing and delivery, fusion proteins and mammalian cell-line-based protein synthesis; drug-device combination experience.

Candidates must be legally authorized to work in the U.S.