Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. The Director, Drug Substance, Process Development & Manufacturing Sciences, will work closely with the Vice President, Process Development and Manufacturing Sciences, on the development and deployment of the technical operations strategy for Dynavax.
Requirements
- Master's degree or PhD in Engineering or a pertinent scientific discipline.
- Minimum 10+ years' experience in CMC operations, with thorough working knowledge of cGMPs and regulatory requirements.
- Experienced CMC leader in the biotechnology industry.
- SME in a broad range of purification technologies and methods.
- 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.
- Ability to sit for prolonged periods; reach with arms and hands; lift and move small objects; use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands and/or fingers.
Benefits
- Full range of health and welfare insurance benefits
- 401(k) company match
- Paid time off benefits, including 17 paid holidays in 2025
