Vice President, Chemistry, Manufacturing, and Controls (CMC)
Full-timeSeniorChemistry, Manufacturing, and ControlsMuscle and metabolic diseasesBiologicsPhDMay Not Sponsor
$290K - $310K/yr
Description
Juvena Therapeutics is seeking a seasoned and strategic leader to join our executive team as the Vice President of Chemistry, Manufacturing, and Controls (CMC). Reporting directly to the SVP of Drug Development, this pivotal role will be responsible for defining and executing the comprehensive CMC strategy for our portfolio from discovery through to clinical-stage development. The successful candidate will lead all aspects of process development, analytical development, and manufacturing, guiding our novel candidates from pre-clinical development and lead optimization through regulatory filings, formulation optimization, scaling, clinical trials and commercialization. The VP of CMC will have expertise in biologics manufacturing and delivery, fusion proteins, and mammalian cell line-based protein synthesis. He/she will have experience and a strong understanding of the requirements for pre-filled syringes as well as drug-device combination development. This is a critical leadership position requiring a blend of deep technical expertise, strategic vision, and operational excellence. The VP of CMC will oversee a primarily outsourced manufacturing model, building and managing strong relationships with a network of Contract Development and Manufacturing Organizations (CDMOs).
Requirements
Advanced degree (Ph.D. preferred) in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline. Minimum of 15+ years of progressive experience in the biopharmaceutical industry, with extensive experience in the CMC development of biologics. Proven track record of leading CMC programs from preclinical stages through Phase 2/3 clinical development. Demonstrated success in managing a fully outsourced manufacturing model. Deep knowledge of cGMP, ICH guidelines, and global regulatory expectations.
Juvena Therapeutics
BIOTECHNOLOGY
Tissue Regeneration & Repair
LocationCA - Redwood City
Open Jobs1
Muscle and metabolic diseases
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