Senior Director, Engineering
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, Engineering will work closely with the Senior Vice President, Technical Operations on the development and deployment of the engineering strategy for Dynavax. He/she will be responsible for providing strategic direction, oversight, and leadership to drive engineering initiatives and activities. Areas of responsibilities may include but are not limited to developing long-term engineering, production, and capacity strategies, and leading operational excellence (OE) initiatives across a wide range of technical and business needs.
Provide Engineering input and oversight as it relates to strategy, project planning and execution, and on-going operations of assigned internal and external projects.
- Evaluation of strategic alternatives for long-term capacity planning for:
- Recombinant protein vaccine antigen (drug substance)
- Oligonucleotide (adjuvant)
- May involve in-house facility expansions, 3rd party manufacturing, or both.
- Act as project leader, coordinating both internal and external cross-functional team members on long-term strategic projects. Including the following:
- Programming works necessary to perform strategic evaluations
- Leading option studies and test-fits
- Capacity evaluations and planning
- Development of conceptual designs and options
- Development of timelines and key milestones
- Providing long-term strategic direction and recommendations based on technical evaluations, data, financial impact and risk
- Establishment of technical transfer plans, as necessary
- Significant cross functional collaboration with Quality, Quality Control, Analytical Development, Manufacturing, MS&T, Supply Chain Management and Regulatory functions.
- Provide 32A1 sections for regulatory filings (BLAs, PASs, CBEs, ARs, etc.) and serve as subject matter expert during regulatory agency meetings and/or inspections (FDA, EMA, etc.).
- Engineering change and deviation SME for both internal and external manufacturing.
- This position may require travel up to 25%
- Degree in Chemical Engineering or Biochemical sciences with at least 10+ years’ experience in Engineering operations, with thorough working knowledge of cGMPs and regulatory requirements.
- The ideal candidate will currently be an experience Engineering leader in the pharmaceutical or biotechnology industry.
- Proven track record of successful engineering project delivery in support of commercial manufacturing (DS and DP).
- 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 Engineering at FDA meetings and regulatory inspections.
- Experience writing relevant CMC sections (32A1) 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.