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Manage CRO interactions for timely DMPK study execution; support regulatory document preparation and presentation/publication strategies. Strong understanding of PK/ADME assays, methods, and models, as well as expertise in managing CROs and knowledge of regulatory guidance’s.
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Experience with GxP compliance requirements and FDA regulatory guidelines as applicable in support of biologics drug development programs. You will be reporting to the Senior Director of Analytical Development and provide technology development, strategic leadership, scientific and technical expertise in protein biologics method development, optimization, and qualification/validation.
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Affini-T Therapeutics is announcing a Senior Director, Head of Product Sciences opportunity at our headquarters in Watertown, MA. Position Summary The Head of Product Sciences role is situated within the larger CMC organization responsible for process development, analytical development, technology transfers, manufacturing, and supply of our drug product TCR T cell candidates, drug substance and critical intermediates such as gene editing reagents, viral (LVV) and non-viral vectors.
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The Senior Director, Drug Safety and Pharmacovigilance will play a key leadership role in characterizing the safety profiles of Dyne products and mitigating and communicating their risks throughout the product lifecycle (from First-In-Human to post-marketing.
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Please note: This position requires an onsite presence of 4 days per week with one day remote.
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Works closely with outside regulatory agencies, parole, probation, families, and other collateral contacts to ensure excellent communication and teamwork between Rushford and our treatment partners.
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Familiarity with inventory control, OSHA, HACCP and other regulatory requirements. Direct: Union and/or non-union warehouse on-floor associates (Loaders, Selectors, Receivers, Forklift drivers, etc.
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You will be the in-house expert of all OSHA, EPA, DOT, NIOSH, NFPA and other regulatory issues relative to the facility and grounds. Competitive salary & bonus potential Comprehensive health benefits Generous PTO & paid holidays 401(k) with match & profit sharing Career advancement opportunities Family values culture & respectful work environmentJob DetailsThe Facility (EHS) Specialist is responsible for ensuring compliance with all OSHA and EPA programs.
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Scientist/Senior Scientist, Cell Line Development. We are seeking a dynamic and experienced Scientist/Senior Scientist to join our team. Lead with hands-on support in commercial cell line development contract campaigns and single-cell assay development.
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Acts as a liaison between contractor and the VAMC.Participates in the ongoing Performance Improvement Program between STGi and VAMC.Complies with all federal, state, local, Joint Commission, Occupational Safety and Health Administration (OSHA), Veteran Affairs, STG and subcontractor safety and operational regulations, directives and standards.
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We are seeking an experienced, creative, and motivated In Vivo Senior Research Associate / Associate Scientist to join our rapidly growing team. We are seeking an experienced, creative, and motivated In Vivo Senior Research Associate / Associate Scientist to join our rapidly growing team.
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Collaborate with cross-functional teams, including translational research, Clin ops, regulatory affairs, Medical Writers etc to ensure alignment of clinical strategies and efficient communication.
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Perform FAI/CVI (Annual) inspections on all fleet vehicles including tractors, trailers, converter dollies, light-duty vehicles, and any other company-owned equipment in accordance with all federal, state, and local legal and regulatory agencies.
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Comply with all federal, state, local, Joint Commission Occupational Safety and Health Administration (OSHA), Veteran Affairs, Subcontractor safety and operational regulations, directives and standards.
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A veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or.
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regulatory affairs jobs Title: senior director in Watertown, Beech-grove, Indiana
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