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Dynavax Technologies · 2 months ago

Director, Drug Substance, Process Development & Manufacturing Sciences

Emeryville, CA

Full-time

Hybrid

Director/Executive

$214K/yr - $232K/yr

10+ years exp

Dynavax Technologies is a commercial-stage biopharmaceutical company developing novel vaccines. The Director of Drug Substance, Process Development & Manufacturing Sciences will oversee CMC initiatives, manage technical operations, and collaborate with various teams to ensure successful project execution.

BiopharmaBiotechnologyClinical TrialsHealth CareMedical Device

Work & Life Balance

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.)

Qualification

CMC operationsPurification technologiesProcess developmentRegulatory submissionsProject managementTechnical leadershipCommunication skillsSelf-motivatedTeam management

Required

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