- Eisai, Inc (Exton, PA)
- …Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations… more
- Merck & Co. (Durham, NC)
- …contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a ... excellence in Compliance, Supply, Continuous Improvement, and Cost Management.--The Associate Director, External Manufacturing Operations will also assist… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leading the development and evolution of overall company strategy for US Operations to drive sustainable growth. This leadership role entails spearheading the ... strategic roadmap for US Operations , involving extensive collaboration with senior US Operations and Global stakeholders. Additionally, this position is focused… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director - Launch Operations will play a pivotal role in managing the ... the role will drive alignment of commercial readiness activities with regulatory , medical, supply, market access and sales Launch readiness governance: Track… more
- Merck & Co. (Durham, NC)
- …Strong planning, scheduling, and time management skills Working knowledge of regulatory requirements in accordance with GMP manufacturing operations Strong ... and filling lines Strong familiarity with eVAL/Kneat Working knowledge of regulatory requirements in accordance with GMP manufacturing operations Experience… more
- Merck & Co. (Durham, NC)
- Job Description Position Description: The Associate Director, HVAC & Utilities Engineer is a member of the Plant Engineering team providing technical support to the ... corrective actions to prevent re-occurrence and help assess the impact on operations . The incumbent will also be responsible for leading plant engineering's… more
- Genmab (NJ)
- …and protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead ... Clinical Operations , Medical, Biomarker Management, Biostatistics, Medical Writing, and Regulatory Affairs to ensure alignment of data strategy with protocol and… more
- Merck & Co. (Rahway, NJ)
- …- Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various ... to identify opportunities for improvement and tackle challenges, balancing effective operations with transformative initiatives.- The Associate Director, Quality… more
- Merck & Co. (Durham, NC)
- …life-saving medicines and vaccines, including our HPV vaccines.DescriptionThe Quality Associate Specialist provides guidance/direction on the shop floor during ... and compliance guidance to employees, colleagues or clients.FUNCTIONAL EXPERTISE:The Associate Quality Specialist will be responsible for comprehensive management of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …drives the long-term strategic direction of Novo Nordisk Inc. (NNI)/North America Operations (NAO) and leads all US commercial efforts for Novo Nordisk's Rare ... collaborators, as we embark on shaping our future. The Position The Associate Director, Rare Bleeding Health Care Professional Marketing Experience has overall… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… more
- Genmab (NJ)
- … operations . The Sr CTA assists with study documentation, regulatory compliance, communication between stakeholders, and overall trial coordination. This position ... to have you join us!The RoleAs Senior Clinical Trial Associate (Sr CTA) you play a key role in...ensuring adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements. Our Sr CTA's are expected to become… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director - Launch Excellence will guide launch planning and execution at NNI - ... the role will drive alignment of commercial readiness activities with regulatory , medical, supply, market access and sales Go-to-market enablement: Coordinate with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …drives the long-term strategic direction of Novo Nordisk Inc. (NNI)/North America Operations (NAO) and leads all US commercial efforts for Novo Nordisk's Rare ... collaborators, as we embark on shaping our future. The Position The Associate Director, Strategic Collaboration role is responsible for fostering partnerships with… more
- Twist BioScience (South San Francisco, CA)
- The QC Associate II will be responsible for the implementation and continuous improvement of QC methods in the production laboratory. He/she will work closely with ... the operations team to monitor the quality of Twist DNA...stored, and distributed are manufactured in compliance with all Regulatory , Customer, and Twist requirements. In this position you… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionContainer Closure Integrity Testing Lead, Associate Principal Scientist, Analytical Research & Development The Analytical Research and Development ... group has an opening for an Associate Principal Scientist based in Rahway, NJ. Join us...external sites and be familiar with current industry and regulatory requirements on CCIT.This position will involve method troubleshooting,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director, Device Technical Operations is a pivotal leadership role within the Device Development & Technology (DD&T) organization in our ... overall business objectives for launch preparedness and enhanced robustness, regulatory , and compliance requirements of the company.Provide executive leadership and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Value process in evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required public forums ... of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good… more
- Merck & Co. (Rahway, NJ)
- …that enables our customers to adapt Industrial Hygiene requirements into daily operations .Being a change agent to ensure all changes to standards, guidelines, ... ofIH concepts, practices, principles and sampling techniques and instrumentationIH regulatory requirements, industry consensus standards, and recognized best practicesAir… more
- Merck & Co. (Durham, NC)
- …policies, procedures and business plan - Receives guidance and oversight from Operations Associate Director and DirectorInterprets client and/or customer needs ... finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting...product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for… more
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