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Director, Process Development & Manufacturing Sciences

Global Technical Operations

US

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.

Direct activities related to process development initiatives for the company’s drug product portfolio programs from IND-enabling stage to commercial product. Responsible for translating business and project needs to appropriate technical plans to best support the company’s pipeline. Effectively interface and collaborate with cross-functional teams both internally and at contract manufacturing organizations (CMOs) to implement plans.

Responsibilities

  • Lead the execution of formulation, compatibility, and process development studies to support phase appropriate development of Dynavax’s drug product portfolio. Duties will include design and execution of programs, evaluation of data, recommendations on strategy, and authoring associated documentation.
  • Manage the technical evaluation of critical manufacturing process parameters for HEPLISAV-B PFS commercial production. Provide technical support for issues arising from ongoing manufacturing of commercial product batches.
  • Oversee technical transfer efforts, process validation, and manufacturing of new or existing drug products at CMOs. Support CMOs for the appropriate studies during the development and validation phases of projects.
  • Author appropriate development reports and documents for internal use and in support of regulatory filings and prepare regulatory submissions or other correspondence with agencies as a subject matter expert. Maintain awareness of regulatory CMC requirements.
  • Proactively identify issues, risks, and opportunities; make recommendations for improvement, mitigation, or changes; and facilitate resolution of issues.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • This position may travel up to 15%.
  • Other duties as assigned.

Qualifications

  • PhD in chemistry, chemical engineering, biochemistry, pharmaceutics, or closely related discipline with 10+ years’ relevant industry experience in a pharmaceutical CMC/GMP environment such as process development, formulation, etc.
  • Demonstrated knowledge and expertise in drug product development, formulation, process development, manufacturing, and regulatory CMC.
  • Must have experience with CMO management and oversight.
  • Excellent communication and interpersonal skills with proven ability to build positive work relationships across functional lines and to motivate employees.
  • Proven ability to translate business objectives to effective technical and operational plans and successful implementation of such plans
    • Demonstrated ability to synthesize information to make critical decisions in a timely manner as well as develop short and long-term plans.
    • Proven ability to translate business objectives to effective technical and operational plans and successful implementation of such plans
    • Demonstrated ability to synthesize information to make critical decisions in a timely manner as well as develop short and long-term plans. 
  • Exceptional interpersonal skills, with proven ability to build positive work relationships across functional lines and to motivate employees.
  • Ability to effectively manage multiple projects.
  • Proven leadership and problem-solving skills.
  • Personal attributes required include:
    • Flexibility and integrity,
    • Goal oriented and self-starter,
    • Practical approach to problem solving,
    • Demonstrated good judgment and decision-making experience,
    • Collaborative and team oriented.

ADDITIONAL KNOWLEDGE AND SKILLS DESIRED:

  • Experience with aseptic processing and vaccine formulation a plus.
  • Team leadership experience.
  • Experience with early phase formulation and process development.