Senior Director, Drug Substance Development and Manufacturing
Global Technical Operations
Dynavax is a fully-integrated biopharmaceutical company dedicated to developing and commercializing innovative vaccines to prevent disease. Our vision and work ethic are guided by the collective ideals underpinning our corporate values, and these form the basis of our dynamic company culture. Our employees are based throughout the United States (including our headquarters in the San Francisco Bay Area) and our manufacturing facility in Düsseldorf Germany.
The Senior Director, Drug Substance Development and Manufacturing will work closely with the Vice President, Technical Operations on the development and deployment of the technical operations strategy for Dynavax. He/she will be responsible for providing strategic direction, oversight and leadership to drive CMC initiatives and activities related to drug substance development. He/she will be a recognized expert in managing the technical, logistical and operational aspects of assigned projects and/or processes from initiation thorough commercialization. The position requires in-depth interactions with technical experts, researchers, regulatory affairs and clinical teams from various functions and external partners.
- Lead drug substance process development, scale-up and or technical transfer projects from initiation through regulatory approval; including the creation of development and/or technical transfer plans.
- Provide CMC oversight as it relates to strategy, project planning and execution, and on-going operations of assigned projects at CROs, CDMOs, etc.
- Significant cross functional collaboration with Quality, Quality Control, Analytical Development, Manufacturing, MS&T, Clinical and Regulatory functions.
- Provide CMC sections for regulatory filings (INDs, BLAs, etc.) and serve as subject matter expert during regulatory agency meetings and/or inspections (FDA, EMA, etc.)
- Master’s degree or PhD in Engineering or a pertinent scientific discipline with at least 15+ years’ experience in CMC operations, with thorough working knowledge of cGMPs and regulatory requirements.
- The ideal candidate will currently be an experience CMC leader in the biotechnology industry.
- Extensive and proven experience with process development, process characterization and process validation of drug substance (microbial and mammalian platforms).
- Proven track record of successful CMC project delivery in support of early stage programs.
- Experience in early development including the transition of novel candidates from discovery through IND, Phase 1 and Phase 2 clinical trials.
- Proactively identify CMC risks and provide recommendations on mitigation.
- Identify, review and select external CROs, CDMOs and key consultants needed to allow smooth, efficient and cost-effective support for CMC programs.
- Excellent verbal and written communication skills.
- Self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards.
- Experience representing technical operations (CMC) at FDA meetings and regulatory inspections.
- Experience writing relevant CMC sections of regulatory documents/submissions.
- Strong technical acumen, leadership, organizational planning, and project management skills.
- Effectiveness in leading, managing and/or influencing people.
- Successful delivery on cost and schedule for projects.