Director, Drug Substance, Process Development & Manufacturing Sciences

Role Summary

The Director, Drug Substance, Process Development and 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. This position will be responsible for providing oversight and leadership to drive CMC initiatives and activities related to drug substance process development. This role will be a recognized expert in managing the technical, logistical and operational aspects of assigned projects and/or processes from initiation through commercialization. This position also requires in-depth interactions with technical experts, researchers, regulatory affairs and clinical teams from various functions and external partners.

Responsibilities

• 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.).

Qualifications

• Master‚Äôs degree or PhD in Engineering or a pertinent scientific discipline.
• Minimum 10+ years‚Äô 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 cell line culturing platforms with purification technologies expertise.
• 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.

Education

• Master‚Äôs degree or PhD in Engineering or a pertinent scientific discipline.