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We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director of GMP Quality Control, who oversees GMP compliance of manufacturing, testing and release activities for SMPA, its partners, contract testing laboratories, and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases.
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Associate Director, GMP Quality Control. Coordinate the extension of expiry dates and communicate changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed.
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Experience in evolving GMP related quality systems, policies, and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows. Responsible for compliance with regulatory filings and therefore must have experience in a Quality Assurance and/or Quality Control function for marketed pharmaceutical products or clinical trial materials.
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Experience in conducting product release activities for clinical and commercial drug substances and drug products; including review and approval of Master Batch Records, Executed Batch Records, batch release, and stability testing documentation, and batch disposition desired.
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Lead and/or present at the Stability and Specification Review Committees for GMP Drug Substance and Drug Product programs. Advanced knowledge of GMP manufacturing and/or market release of pharmaceutical dosage forms and/or combination products desired.
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This role works with internal stakeholders and external partners to ensure released drug supply within expiry date is available to support commercial product and clinical program needs. Experience desired with drug delivery devices, diagnostics, biomarker, and genetic testing.
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Develop/support GCP inspectional readiness plans and lead inspectional readiness activitiesHost and/or assist with management of GCP-related inspectionsPartner with GMP Quality and Clinical Operations teams to facilitate the investigation of clinical supply quality issues such as temperature excursions, product complaints and deviations reported from clinical sites.
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Aseptic, Sterile Injectables, cGMP, Downstream, Fill finish, Gmp, Cleanroom, Laboratory, Contract Manufacturing, Compound, Compounding, batch processing, Autoclave, pharmaceutical manufacturing, pharmaceutical, gowning, Chemistry, Sop, Batching, Aseptic technique, Quality assurance, Inspection, Sanitization, Batch record.
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The role oversees and manages the Development QA team and interacts cross-functionally with functional teams who interact with and/or support Preclinical and Clinical Trials, which include Preclinical and Clinical Operations; and, Product Development, GMP teams, Pharmacovigilance, Medical Writing, Biostatistics and Data Management to ensures compliance to the Quality Management System (QMS) and all applicable regulatory requirements.
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Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Knowledge of GMP and regulatory requirements applicable to cell and gene therapy drug products.
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Optimize pilot plant and pre-clinical production performance to allow for fast, flexible processing of multiple manufacturing processes including plasmid DNA prep, mRNA transcription and purification, and LNP formulation, and oligonucleotide synthesis.
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Extensive expertise in U/HPLC, CE, SDS-PAGE, mass spectrometry, and other analytical technologies as applied to protein analytical method development, trouble shooting and validation for GMP release and stability testing.
$144,000 - $162,000 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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QA compliance manager, quality assurance, QA, management, GxP, GCP, GLP, GMP, auditing, clinical research, regulatory, inspections, sponsor audits, stakeholder management, process improvement, travel, investigator site audits, TMF audits, QMS, communication, remote, united states, US.
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Summary: We look forward to welcoming a Bioprocess Engineer with a solid understanding of bio-chemical engineering fundamentals and modeling expertise to support our laboratory, pilot and clinical scale process development, technology transfer to internal and external GMP production facilities for our novel cell free expression-based therapies.
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The group supports non-GMP transient protein lead production across the companies diverse biotherapeutic discovery portfolio to enable the research units and their pre-clinical therapeutic in-vitro and in-vivo needs.
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