Job description
This position can be 100% remote, but must be located in the United States.
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, 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 thorough 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’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.
$214,000 - $232,000 a year
The estimated salary range for this position is $214,000 to $232,000. 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 2025.
#LI-REMOTE
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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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
