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This position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. Technical knowledge in metrology, calibrations, instrumentation, automation PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance, EHS and regulatory standards (e.g. EPA, OSHA and DEA.
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Position Status Full Time Posting Number 24FA0466 Posting Open Date 05/02/2024 Posting Close Date 06/30/2024 Qualifications Minimum Education and Experience Candidates should have a Ph. D. degree in Cell Biology, Neuroscience, Structural Biology, Microbiology, Bioengineering, or a related area.
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EXPERIENCE/EDUCATION: · B.S. in Science Field or related discipline is required (Chemistry or Bio Chemistry is preferred) · Knowledge in oligonucleotide synthesis and PCR technology is desirable · Knowledge in lab equipment automation and programming · Ability to work under cGMP guidelines, and coordinate/implement production schedule is necessary If interested, please share your updated resume at.
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7+ years experience in a GMP environment with knowledge of cGMP regulations and a background in microbiology. Requirements Bachelor's degree in Biology, Microbiology, or other laboratory-based life science; or equivalent combination of education and experience.
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Education : Medical Degree preferable or PhD with significant vaccinology or infectious disease expertise (e.g. Virology/ Microbiology/ Respiratory Medicine/ pediatric or public health) Education : Medical Degree preferable or PhD with significant vaccinology or infectious disease expertise (e.g. Virology/ Microbiology/ Respiratory Medicine/ pediatric or public health.
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This individual will play a critical role in the logistics processes ensuring appropriate controls, complete traceability, and efficient operations to support the production of cell therapy products through safe and compliant manufacturing operations according to cGMP requirements.
$90,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Other courses that would be helpful are: Microbiology, Organic Chemistry, Analytical Chemistry, Instrumentation Analysis, Molecular Biology, Cell Biology, Biochemistry Benefits: Atrium Care Package available, upon eligibility.
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The Quality Specialist provides support for the business' product development portfolio and ensures adherence to CGMP compliance in a regulated environment. Prior experience in a GMP quality (Manufacturing/QA/QC) environment, experience in drug substance, drug product and final packaged product a plus.
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This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements.
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The candidate will be responsible for executing cell culture batches from L to 0 L volumes engineering and clinical batches in a cGMP environment. Perform cell culture and bioreactor operations at multiple scales.
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The Senior Supervisor QA Investigations is responsible for supervising the team involved in quality systems support of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
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General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
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This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements. The candidate will be responsible in the purification of 50L to 1000L volumes engineering, clinical and commercial batches in a cGMP environment.
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Bachelor’s degree in Chemistry, Chemical Engineering, Microbiology, Pharmaceutical or related fields with experience in pharmaceutical industry. We deliver and maintain high quality and integrity in all our products that are manufactured in world-class cGMP manufacturing facilities.
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Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis. The Downstream Manufacturing Scientist is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars.
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