Director, Process Development & Manufacturing Sciences

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Job Description - Director, Process Development & Manufacturing Sciences

This position can be 100% remote.

Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. We operate with the highest level of quality, integrity and safety for the betterment of public health. Our proprietary CpG 1018 adjuvant powers our diversified infectious vaccine portfolio, which includes HEPLISAV-B®, our commercial product approved in the U.S. and the European Union, for prevention of hepatitis B virus in adults. We also supply CpG 1018 to research collaborations and partnerships globally. Currently, CpG 1018 is being used in development of COVID-19, plague, shingles, and Tdap vaccines.

At Dynavax, our vision and work ethic are guided by the collective ideals underpinning our core values, and these form the basis of our dynamic company culture. We strive to maintain a culture where each employee is valued by the organization and where our organization is valued by each employee. We offer a highly flexible work environment for our headquarter employees where individuals work remotely and gather for in-person meetings when necessary. Dynavax is headquartered in the San Francisco Bay area, and our manufacturing facility is in Düsseldorf, Germany.

The Director, Process Development & Manufacturing Sciences will direct activities related to process development initiatives for the company's drug product portfolio programs from IND-enabling stage to commercial product. This position will be responsible for translating business and project needs to appropriate technical plans to best support the company's pipeline. This position will also 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.
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. 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 development, process development, manufacturing, and regulatory CMC.
Experience with aseptic processing and vaccine formulation.
Experience with early phase formulation and process development.
Must have experience with CDMO management and oversight.
Excellent written and oral communications skills.
Exceptional 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.
Ability to effectively manage multiple projects.
Proven cross-functional team leadership experience 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.
Ability to sit; stand; walk; reach with arms and hands; lift and move small objects; and use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands and/or fingers.
Pay Range The estimated salary range for this position is $200,000 to $218,000. Final pay determinations may depend on various factors, including, but not limited to experience level, education, geographical location, knowledge, skills, and abilities. The total compensation package for this position also includes other compensation elements such as stock equity awards and participation in our Company's discretionary annual bonus program. Dynavax also offers a full range of health and welfare insurance benefits, 401(k) company match, and paid time off benefits, including 17 paid holidays in 2024.

#LI-REMOTE

California residents: for information on how we handle your personal information and your privacy rights as a job candidate, please see our Candidate Privacy Notice: https://www.dynavax.com/file.cfm/53/docs/dynavax_privacy_notice_for_california_applicants.pdf

Dynavax is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
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