Director, Drug Substance, Process Development & Manufacturing Sciences

November 7

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $214k - $232k / year

⏰ Full Time

🔴 Lead

👔 Director

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Dynavax Technologies

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Biotechnology • Pharmaceuticals

Dynavax Technologies is a commercial-stage biopharmaceutical company focused on developing and commercializing novel vaccines to combat infectious diseases. The company utilizes proven and innovative adjuvant technology, such as its CpG 1018® adjuvant, to enhance the effectiveness of vaccines, including its HEPLISAV-B® product. With a commitment to making a global impact on public health, Dynavax actively engages in clinical trials and values driven team collaborations to advance its pipeline of vaccine solutions.

201 - 500 employees

Founded 1996

🧬 Biotechnology

💊 Pharmaceuticals

💰 $200M Post-IPO Debt on 2021-05

📋 Description

• 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 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 a subject matter expert during regulatory agency meetings and/or inspections (FDA, EMA, etc.).

🎯 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. • 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. • 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

• health and welfare insurance benefits • 401(k) company match • paid time off benefits, including 17 paid holidays in 2025.