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
