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Associate Director of Communications - Global Agriculture at Simplot in Boise, Idaho, United States Job Description Associate Director of Communications - Global Agriculture Location: Boise, ID, US, 83702-6924 The J.R. Simplot Company is a diverse, privately held organization, with roots firmly planted in agriculture and agriculture-related businesses.
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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. The Associate Director ensures compliance with GMPs, SMPA procedures and applicable global Regulatory guidelines by providing oversight and management of the global contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates in drafting and reviewing CMC sections of the IND, IMPD and BLA/NDA submissions.
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Experience desired with drug delivery devices, diagnostics, biomarker, and genetic testing. Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies.
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Experience working in more than one product area (e.g. solid oral dose, injectables, combination products), and therapeutic area (e.g. oncology, urology, regenerative medicine) within Quality Control a plus.
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Well versed in analytical and characterization procedures for biopharmaceuticals and small molecules including HPLC, GC, MS, electrophoresis, immunoassays, bioburden, endotoxin, moisture, assay, and dissolution testing.
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Advanced knowledge and use of software applications, including LC chromatographic analyses, statistical applications, and quality management systems (e.g. Veeva). Partners with CMC to conduct method transfers and validation of new or existing analytical methods for release and stability testing of drug substance, drug product and other materials, to domestic and international contract manufacturing organizations and testing laboratories.
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For CMOs with aseptic processing, review media fills, and environmental monitoring data as it relates to lot release, change control and facility re-starts. Review and approve Quality Events, Investigations, CAPA, Change Controls, and Complaints in eQMS.
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Coordinate the extension of expiry dates and communicate changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. Contribute to product development by making recommendations for manufacturing controls, sampling and testing to ensure product quality and compliance with GMPs from development through commercialization.
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Participate, as needed, in audits of contract laboratory sites and support annual Risk Assessments as part of the Supplier Quality program. Experience with managing external CMO and contract laboratory environments.
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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. Minimum of Bachelor's degree in a scientific discipline (e.g., biology, chemistry, engineering, pharmacy) or relevant field of study.
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Quality leader and quality culture promoter within the global organization. Building on Sumitomo Pharma's 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner.
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Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.
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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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Perform QC check for regulatory submissions to ensure accuracy and data integrity. Review regulatory IND, IMPD, CTD and BLA/NDA CMC sections. 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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associate director jobs Title: buyer Company: Bloodworks
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