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Serve as Cresilon's Subject Matter Expert (SME) and technical lead in Current Good Manufacturing Practices (cGMP) analytical chemistry. Mentor and train staff on cGMP analytical chemistry expectations.
$135,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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12+ years of operations experience in a cGMP biotech/biopharma environment, with a minimum of 5 years in leadership; cell/gene therapy experience is essential. We are in search of an enthusiastic and driven Senior Director of Cell Therapy Operations to oversee the readiness, launch, ramp-up, and management of cGMP operations within our cutting-edge multi-product cell therapy manufacturing facility.
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This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company’s clinical and commercial products follow cGMP framework and guidelines. Performs disposition activities for manufactured products in support of clinical products, including MBR, EBR review, and approval and review of CoA. Responsible for Management and maintenance of the Veeva Quality Docs System, including document drafting/Authoring, reviewing, approving, and finalizing internal quality documents (SOPs, Wis, Policies, Forms, etc.
$1 - $2ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ideal candidate will have extensive CMC (Organic and/or Analytical chemistry) experience with at least 10 years in CMC-QA leadership roles. The Associate Director, Quality Assurance will be based in our Northern New Jersey, offices 1 - 2 days a week (flexible schedule for the ideal candidate.
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Key Responsibilities Provide quality leadership, strategy, and compliance oversight to CDMOs, CMO, CRO, CPO, Third Party Vendors. Associate Director-Quality Assurance (QCMC) Company is seeking a highly experienced, motivated, and innovative quality leader with strong experience in early and late-stage development to join our Quality team as Associate Director, Quality Assurance to support drug development from Phase 1 to late-stage development.
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As a QC Laboratory Analyst, you could work in an analytical or microbiological laboratory environment that stays in sync with Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP.
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Assist in the development, approval, maintenance, review, management of agreements (such as QAA, MSD, consulting agreements etc. Ensure that CMC quality systems, validation, product specifications, product release, reference standard and stability programs are phase appropriate, effective, meet standards expected by US and global regulatory authorities.
$1 - $2ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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In addition, you will ensure quality of product in accordance with all NYBC’s Standard Operating Procedures, work instructions and regulatory standards, as well as following and practicing cGMP in all work.
$21.6,564ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Knowledge of codes, standards and guidelines as related to labs, individual municipalities, State, IBC, ADA, ANSI, NFPA, NSF, cGMP and cGLP required. Knowledge of codes, standards and guidelines as related to labs, individual municipalities, State, IBC, ADA, ANSI, NFPA, NSF, cGMP and cGLP required.
$160,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This position requires experience with hands on testing in a Quality Control laboratory operating within a cGMP environment. Hands-on experience with HPLC, GC, Dissolution, and use of Empower software.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Knowledge of various government regulations such as, Current Good Manufacturing Practice (cGMP), National Electrical Testing Association (NETA), Environmental Protection Agency (EPA), and Occupational Safety and Health Administration (OSHA.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Experience in cGMP/GLP laboratory. This role is on-site in Maple Grove, MN. Provides analytical pharmaceutical development and analysis support to an analytical pharma team within a large materials science and analytical chemistry laboratory.
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Provides analytical pharmaceutical development and analysis support to an analytical pharma team within a large materials science and analytical chemistry laboratory. Experience with HPLC, GC, Empower, and MassHunter strongly preferred.
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2+ years of experience in a manufacturing/packaging cGMP environment. Human Technologies, Inc. (HTI) has been a trusted partner since 1999, collaborating with leading companies to deliver tailored solutions for workforce management, development, and retention.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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This role involves overseeing the development, implementation, and maintenance of plant quality systems in a cGMP-driven environment, managing customer, supplier, internal, and external audits, and ensuring compliance with BRC standards.
ExpandApply NowActive JobUpdated 8 days ago
cgmp job in New York, NY
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