-
Director, Process Development
1 week ago
Dynavax Technologies Emeryville, United StatesThis 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 ...
-
Director, Process Development
1 week ago
Nava Emeryville, United StatesThis 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 o ...
-
Manager, Plasmid Process Development
2 weeks ago
Metagenomi Emeryville, United States Full time· Metagenomi is a gene editing company committed to developing potentially curative therapeutics by leveraging a proprietary toolbox of next-generation gene editing systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and ...
-
Bioconjugation Process Development Director
3 days ago
Exelixis Alameda, United StatesSUMMARY/JOB PURPOSE: · The Bioconjugation Process Development Director is responsible for the process development and manufacturing of large molecule bioconjugates for biotherapeutics, with a focus on Antibody Drug Conjugates (ADCs). The successful candidate will drive the CMC e ...
-
Bioconjugation Process Development Director
2 hours ago
Exelixis Alameda, United StatesSUMMARY/JOB PURPOSE: · The Bioconjugation Process Development Director is responsible for the process development and manufacturing of large molecule bioconjugates for biotherapeutics, with a focus on Antibody Drug Conjugates (ADCs). The successful candidate will drive the CMC e ...
-
The Boeing Company Berkeley, United StatesJob Description · At Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We're committed to fostering an environment f ...
-
Process Development Engineer
1 week ago
Twelve Alameda, United StatesJob Description · Job Description · Twelve is a new kind of chemical company built for the climate era. Our breakthrough technology eliminates emissions by turning CO2 into essential products. We are a team of scientists, engineers and problem solvers on a mission to fundamenta ...
-
Velocity Solutions Larkspur, United StatesAs a Process Developer for HV Testing Technology at Larkspur, you will be responsible for the conceptualization, commissioning, and validation of partially and fully automated measurement and testing devices. As the main point of contact for your projects, you will be a member of ...
-
Bioconjugation Process Development Director
2 weeks ago
Exelixis Alameda, United StatesSUMMARY/JOB PURPOSE: · The Bioconjugation Process Development Director is responsible for the process development and manufacturing of large molecule bioconjugates for biotherapeutics, with a focus on Antibody Drug Conjugates (ADCs). The successful candidate will drive the CMC e ...
-
Process Development Engineer II/III
2 weeks ago
Lygos Inc Berkeley, United StatesLygos is an industrial biotechnology company developing biobased sustainable solutions to improve everyday products. Our technology platform enables better economics and unlocks the power of organic acids specialty chemicals, enabling our partners to offer sustainable alternative ...
-
Process Development Engineer
2 weeks ago
Twelve Alameda, United StatesJob Description · Job DescriptionTwelve is a new kind of chemical company built for the climate era. Our breakthrough technology eliminates emissions by turning CO2 into essential products. We are a team of scientists, engineers and problem solvers on a mission to fundamentally s ...
-
Process Development Engineer
1 week ago
Aether Biomachines Menlo Park, United States Full timeThis is an Exempt, Full Time position based in our Menlo Park, CA office (San Francisco, CA in the near future). This position reports to the Executive Vice President of Engineering of the Company. · Aether Biomachines is on a mission to build the post-scarcity future using pepti ...
-
Process Development Engineer
1 week ago
Twelve Alameda, United StatesJob Description · Job DescriptionTwelve is a new kind of chemical company built for the climate era. Our breakthrough technology eliminates emissions by turning CO2 into essential products. We are a team of scientists, engineers and problem solvers on a mission to fundamentally s ...
-
Process Development Engineer
2 weeks ago
Aether Biomachines, Inc San Francisco, United StatesThis is an · Exempt, Full Time · position based in our Menlo Park, CA office (San Francisco, CA in the near future). This position reports to the Executive Vice President of Engineering · of the Company. · Aether Biomachines is on a mission to build the post-scarcity future u ...
-
Process Development Engineer
3 weeks ago
MP Mine Operations LLC San Francisco, United StatesJob Title: · Process Development Engineer · Location: · Mountain Pass, CA · Department/Group: · Product Engineering · Position Type: · Full Time · Hourly/Salary: · Salary · Regular/Temp: · Regular · Exempt/Non-Exempt: · Exempt · Reports To: · Principal Engineer · ...
-
Genomic Health, Inc. Redwood City, United States Full timePosition Overview · The Lead Engineer, Process Development and Automation leads, manages, implements, and provides technical engineering support for a variety of process automation hardware, software applications, and laboratory instruments. This position works and collaborates c ...
-
Exelixis Alameda, United StatesSUMMARY/JOB PURPOSE: · The Associate Director provides technical leadership and support across multiple CMC biologics areas to drive downstream process development, technology transfer, and manufacturing of biological drug candidates with a focus on therapeutic proteins' purifi ...
-
Process Development Specialist
3 weeks ago
University of California San Francisco San Francisco, United StatesThe Department of Laboratory Medicine at the University of California, San Francisco(UCSF) is seeking a motivated and detail-oriented individual to join our Investigational Cellular Therapy (ICT) group. ICT aims to push the boundaries of medicine by developing, engineering, and m ...
-
Process Development Engineer Senior Staff
3 weeks ago
Confluent Medical Technologies Fremont, United StatesJob Description · : Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed u ...
-
Horizon Dynamics Antioch, United StatesThe Motherson Group is one of the top 21 and fastest growing providers of complete system solutions for the global automotive industry, serving a variety of other industries such as railway, aerospace, medical, IT, and logistics with over employees in 41 countries worldwide. Samv ...
Director, Process Development - Emeryville, United States - Dynavax Technologies
4 weeks ago
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 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.
ResponsibilitiesLead 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.QualificationsPhD 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 RangeThe 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-REMOTECalifornia residents:for information on how we handle your personal information and your privacy rights as a job candidate, please see our
Candidate Privacy Notice:
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.
