Job details
Job type full-time
Not provided by employer
Full job description
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 diseasesWe operate with the highest level of quality, integrity and safety for the betterment of public healthOur proprietary cpg 1018 adjuvant powers our diversified infectious vaccine portfolio, which includes heplisav-b®, our commercial product approved in the u.sAnd the european union, for prevention of hepatitis b virus in adultsWe also supply cpg 1018 to research collaborations and partnerships globallyCurrently, cpg 1018 is being used in development of covid-19, plague, shingles, and tdap vaccinesAt 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 cultureWe strive to maintain a culture where each employee is valued by the organization and where our organization is valued by each employeeWe offer a highly flexible work environment for our headquarter employees where individuals work remotely and gather for in-person meetings when necessaryDynavax is headquartered in the san francisco bay area, and our manufacturing facility is in düsseldorf, germany.
The director, drug substance development and manufacturing sciences will work closely with the senior director, drug substance development and manufacturing on the development and deployment of the technical operations strategy for dynavaxHe/she will be responsible for providing oversight and leadership to drive cmc initiatives and activities related to drug substance developmentHe/she will be a recognized expert in managing the technical, logistical and operational aspects of assigned projects and/or processes from initiation thorough commercializationThe position 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 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 with at least 10+ years’ experience in cmc operations, with thorough working knowledge of cgmps and regulatory requirements.
The ideal candidate will currently be an 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.
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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Posted 9 days ago
