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Collaborate with Sana colleagues in Stem Cell Sciences and Technical Operations to enable the manufacturing of Sana’s gene edited PSC therapies in a controlled/cGMP environment. Collaborate with Sana colleagues in Stem Cell Sciences and Technical Operations to enable the manufacturing of Sana’s gene edited PSC therapies in a controlled/cGMP environment.
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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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Proven understanding of cGMP antibody upstream process development and production using CHO host cell expression systems at bench or pilot scale. The Upstream Process Development team is responsible for the development and implementation of upstream processing methodologies on monoclonal antibodies that can be efficiently transferred to the cGMP Manufacturing Team and our CDMO partners.
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Adhere to all Humacyte Quality Management System (QMS), cGMP, SOP, and policies. Conducts all assigned activities in a safe and cGMP manner. Basic knowledge of cGMP requirements, preferred.
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Leverage your proficiency in small molecule drug development to drive and execute CMC development plans to support cGMP manufacturing. Prepare and defend CMC regulatory documents enabling global filings.
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As a Field Service Engineer, you will delight our customers with timely onsite support of 10x Genomics instruments, ensuring compliance with company policy, cGMP, ISO, State Regulatory agencies, and the FDA.
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The Senior Quality Assurance Specialist provides Quality support for Petaluma site and ensures adherence to cGMP compliance in a regulated environment. Strong technical experience in a cGMP pharmaceutical setting.
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Expertise in Quality Systems and cGMP standards applicable to method validation for clinical and commercial products and AO/QC laboratory operations. May assist with cGMP compliance audits at contract partners and may interface with regulatory agencies during inspections.
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What You’ll BringA minimum of 10 years of process engineering design experience in cGMP, FDA, or other regulated manufacturing environments. Subject-matter expertise in cGMP regulations and standards (preferred.
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Lead packaging activities supporting multiple clinical programs in all phases of development, ensuring on-time delivery of project deliverables and compliance to current Good Manufacturing Practice (cGMP.
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Engineer pure water systems including RODI, WIFI and other high purity filtration. Engineer fire protection systems including sprinkler, fire pump, water storage, containment, gaseous suppression and misting systems.
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As a quality functional site lead at CTLs, supports quality initiatives and responsible for providing quality metrics, trend reviews, and risk assessments. analytical chemistry, test method development, pharmaceutical industry.
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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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Plan and execute test method validation projects, including developing, performing, and documenting test method validation activities in accordance with cGMP. Draft, review, and approve design control documents (DHF documents) to support device developement deliverables, such as protocols, design verification, design validation, FMEA, risk management plans, change management plans, and design review.
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Ensure compliance with FDA and CGMP quality standards. Ensure compliance with FDA and CGMP quality standards. Knowledge of GMP and quality systems. High School Diploma; BS in Food Science preferred.
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cgmp job in South San Francisco, CA
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