Director, Pharmaceutical Manufacturing

A pharma company in California is actively seeking an experienced professional to join their team as their new Director, CMC Pharmaceutical Manufacturing. Responsibilities: Manage/lead external drug product manufacturing of small molecules in a cGMP environment Manage/lead production planning, execution, and tracking Manage CMO relationships and foster collaborative partnerships. Lead and/or contribute to CMO selection and onboarding Support and/or lead CMC projects of Ultragenyx´s small molecule portfolio Be an integral part of cross-functional and cross-discipline CMC teams for products that include synthetic components Develop and maintain CMC manufacturing activities, Product Design History File and Quality Risk Management Plan Manage process development and optimization technology transfer as well as production related change controls, deviations, and complaints Drive RFPs, SOWs, MSAs, and other governance documents Promote and implement knowledge management processes for appropriate sharing and storage of documentation Provide representation on global projects and in functional and cross-functional teams Qualifications: 10+ years or more of relevant experience in small and/or large Biopharmaceutical companies and working in global organizations Ph.D. or equivalent work experience in Pharmaceutical or Engineering Sciences Demonstrated experience with participation in and/or leading CMC teams and executing CMC activities Experience in development and clinical manufacturing of small molecule formulations and manufacturing of drug products Experience in QbD, DoE, process optimization and qualification/validation, phase-appropriate manufacturing controls, up-to-date with new mfg technologies including PAT Familiarity with current regulatory landscape for small molecule DPs Working knowledge of quality and regulatory requirements of small molecule products, including ICH guidelines Desired Skills: Experience in formulation of multiple dosage forms Knowledge of Antisense Oligonucleotide products Experience with Analytical Development and Quality

#J-18808-Ljbffr