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In-depth knowledge of relevant EHS regulations, standards, and best practices, including but not limited to OSHA, EPA, FDA, and cGMP requirements. Professional certifications such as Certified Safety Professional (CSP), Certified Industrial Hygienist (CIH), or Certified Hazardous Materials Manager (CHMM) preferred.
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In meeting these goals, the Drug Product Director will ensure that the facilities are maintained in a cGMP-compliant state. Provides leadership in ensuring that all GMP raw materials and supplies are compliant with cGMP.
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With 180+ staff, they provide programming, master planning, building and interior design services, including laboratory, cGMP and medical planning, to new and established companies, institutions, developers and healthcare providers.
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Opened in 2023, the facility serves as a central location where customers and UCSF researchers will have access to Thermo Fisher Scientific's broad portfolio of solutions and clinical and commercial cGMP cell therapy manufacturing services, along with associated technology development support to our partners.
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Responsibilities include managing QC samples, shipping, and testing logistics, reference standard inventories, and data entry from CTLs/CMOs into Gileads LIMS. The role will contribute to QC procedures across Gileads biologics manufacturing network, ensuring global cGMP compliance.
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Resolve cGMP deviations and investigations and assure appropriate corrective and preventive actions (CAPAs) are implemented at CMO and internally. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN), also known as Berger’s disease and lupus nephritis.
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EXP is seeking an experienced and motivated Plumbing Designer/Engineer 2 to work in a flexible role that includes engineering, design and specification of building mechanical, electrical, plumbing, fire protection and process systems for Life Sciences, Research and Development, Pharmaceutical, and cGMP Projects.
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Support instruments in a cGMP/cGXP environment, while minimizing instrumentation and equipment downtime. Attend cGMP training as required by Department policy. Utilize computer skills to navigate and use corporate intranet, standard word processing, spreadsheet programs, maintenance management system, and calibration management system.
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The role will contribute to refining QC procedures across Gilead's biologics manufacturing network, ensuring compliance with global cGMP and Gilead's Quality Management System. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
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You have a minimum of 3 years biopharmaceutical industry experience within upstream cell culture development or process development; MSAT, cGMP Manufacturing and/or Tech Transfer experience a plus.
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Recent experience in a clinical laboratory setting that handle cell therapy products using aseptic technique, knowledge of cGMP, cGTP and cell therapy product processing and cryopreservation. Under the direction of the Pediatric Cellular Therapy Laboratory (PCTL) Senior Supervisor, the Clinical Lab Scientist Supervisor has leadership responsibility and appropriate authority for administrative and fiscal functions as assigned.
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Manage multiple global CDMOs for tech transfer, process optimization, process scale-up and cGMP manufacturing and testing to ensure IP supply for ongoing clinical programs and commercial launch.
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AA or BA/BS in a technical field (biotechnology, chemical engineering, bioengineering, microbiology, biochemistry) or equivalent experience, and experience working in a cGMP industrial setting. Our ideal candidate brings previous experience in a cGMP bioprocess or biotechnology setting, and enjoys working with precision in a fast-paced, changing environment, while bringing attention to detail, collaboration, passion, and dedication to their work.
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Strong knowledge of US and European cGMP guidelines and requirements. Support the tech transfer and production for late-stage and commercial supply. Author and review regulatory submission documents to help support an NDA/MAA.
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How to apply your experience in bioprocess & cell culture to the production of next-generation seafood utilizing cGMP practices. We were founded in 2016 by Aryé Elfenbein, a cardiologist and molecular biologist, and Justin Kolbeck (CEO), a former US diplomat who served in Pakistan and Afghanistan, in an effort to solve one of the world's biggest problems: how to feed a growing population without stripping the earth of its natural resources and biodiversity.
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cgmp job in South San Francisco, CA
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