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We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
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Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP. At least 5 years of QA or Manufacturing experience in a GMP manufacturing environment with a Bachelor’s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry or related field.
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Experience in Quality Management, Good Laboratory Practices (GLP), and Good Manufacturing Practice (GMP) Analytical Skills: must have the ability to interpret analytical assay data.
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Work with the BST network of specialty labs to support delivery of high quality bioanalytical and biomarker data to clinical programs, ensuring adherence to the requirements of quality, and ethical and regulatory standards, including ICH/GDPR/GCP/IVDR/GLP.
$209,000 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS). Extensive experience managing deviations, RCA and CAPAs in a GLP/GCP environment.
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This is a small molecule focus analytical development role supporting new and improved analytical methods and commercial processes, physicochemical characterizations in support of process development, and/or technology transfer to Contract Manufacturing Organizations (CMO.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Our site in Billerica, MA is seeking a QA Analytical Chemist II to join our team. Analytical Chemist II - 3rd Shift. The QA Chemist is responsible for conducting QA testing and will provide analytical support to production of our Micro-contamination control and membrane products as well as for R&D development.
$85,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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We are recruiting a Scientist/Sr. Scientist with experience in phase-appropriate analytical method development, optimization, and qualification of physicochemical assays for lot release, stability, and characterization of cell and gene therapy products to support Beam’s in vivo programs using lipid nanoparticle (LNP) delivery.
Full-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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The Senior Director of Analytical Development scope will span programs across the Biologics, Vaccines, Gene Therapy, Cell Therapy or Nucleic Acid franchises. Resilience is seeking a highly experienced and scientifically-driven Senior Director of Analytical Development , who will lead the Analytical Development functions across the Biologics, Vaccines, Gene Therapy and Nucleic Acid technology areas.
$280,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Thousands of organizations worldwide, including Barclays, Cisco, eBay, Fairfax, ING, Goldman Sachs, Microsoft, The Mayo Clinic, NASA, The New York Times, Wikipedia, and Verizon, use Elastic to power mission-critical systems.
$303,500 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Vertex pharmaceuticals is seeking a research scientist to join the analytical development, cell and gene therapy team. Collaborate with research and process development teams to develop fit for purpose analytical characterization methods for target optimization, product characterization and product investigations.
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In this matrix leadership role, the candidate will act as the Analytical Product Lead (APL) and have primary responsibility for overseeing programs through the late-stage drug development lifecycle, Marketing Authorization/Biologics Licensure application (MAA/BLA), and Life Cycle management.
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In-depth working knowledge of the applicable cGMP/GCP/GLP/GVP regulations and guidelines in a pharmaceutical environment. This role will develop strong relationships, collaborate, and interact with various departments (i.e., Quality Operations, Quality Systems, Chemistry Manufacturing, and Controls (CMC), Analytical, Regulatory Affairs, Pharmacovigilance, Procurement), and all levels of management at Akebia to accomplish company objectives.
$189,501 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture. The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
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You will report to our Scientist, Analytical Development, and work closely with T Cell Process Development. Experience in analytical method development, especially understanding in molecular assays for T cell product characterization and release.
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glp job Title: analytical Company: Pci Services in Woburn, MA
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