- Merck & Co. (Rahway, NJ)
- …from concept generation/selection, development, verification, and validation to launch readiness : Lead the cross-functional Combination Product Working Groups to ... and regulatory aspects of combination products.The incumbent must be able to lead cross-functional development teams within DD&T and across our company, and work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … readiness .Stay current with emerging technologies and industry trends; lead feasibility studies, prototype development, and advocate for scalable, compliant ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating ... and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile… more
- Merck & Co. (Rahway, NJ)
- …Overview: As the Associate Director of Launch Strategy and Operations, you will lead the enterprise preparation of multiple product launches in Immunology. You will ... cross-functional teams to develop and implement strategic launch plans, ensuring market readiness and optimizing commercial success. This role requires a blend of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …support to audits and Health Authority inspections, including readiness activities, to ensure internal/external compliance with requirements/regulations Support, ... areas of the business Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of processes and… more
- Merck & Co. (Rahway, NJ)
- …and GMP requirements. This position is also responsible for ensuring facility readiness for batch processing and shares accountability for the building performance. ... SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical ... assigned GMA plan activities, in collaboration with Sr Director.- Support medical readiness activities for market launches and life cycle management for select… more
- Twist BioScience (South San Francisco, CA)
- …experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, ... align with our overall manufacturing strategy and business objectives. The Director will lead a team of MES professionals, primarily software developers, who work in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction of the Senior Director, USMA Oncology (US Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical ... affairs plan activities, in collaboration with Sr. Director.- Leads medical readiness activities for market launches. This includes strategic partnerships with the… more
- Merck & Co. (Rahway, NJ)
- …its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the ... facility, concluding startup and operational readiness activities.Once the facility is operational, this role will...New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and statisticians, ... and evolve the Data Science team to meet internal and market needs. Lead a high-performing, collaborative team environment.Core member of the AI Center of… more
- Merck & Co. (Durham, NC)
- …Primary Responsibilities and Activities include but are not limited to : Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant Supply: ... Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with External… more
- Merck & Co. (Rahway, NJ)
- …The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The ... spending per approved spend plans.- Areas supported include FLEx Sterile1, with operational readiness in 4Q2025, and a secondary focus on FLEx Sterile2, currently in… more
- Merck & Co. (Rahway, NJ)
- …on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global and ... part of the design.- Provide information and drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the ... SME to support Quality Investigations, Corrections, and QMS records.Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a Right First Time culture of quality, permanent inspection readiness compliance mindset and passionately drives continuous improvementProvides technical expertise ... experience working and leading in a matrix environmentAbility to lead with influencecGMP manufacturingMetrology, calibrations, instrumentation, automation PLCs, VFDs… more
- Eisai, Inc (Nutley, NJ)
- …close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates clinical study timelines. Gathers ... enrollment figures to COL or leadership team as requestedContribute to inspection readiness , including, but not limited to, creating and updating various folders and… more
- Freeport-McMoRan (Phoenix, AZ)
- Operational Readiness Lead Requisition ID: 138848 Location: Phoenix, AZ, US, 85004-2121 Category: Admin Support Share this Job Why You Should Apply For This Job: ... and a timely ramp up to planned production targets. + Lead evaluation of operational readiness activities with site leadership across all functions including but… more
- International (Lisle, IL)
- Position Overview International Procurement has an exciting opportunity for a Sourcing and Readiness Team Lead . As a Sourcing and Readiness Team Lead , ... mentor and support a team of 4 sourcing and readiness managers as we drive towards quality execution and...per the predefined category strategy and managing your supplier readiness and component industrialization from tool kick off through… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Data Integrity Inspection Readiness Lead uses advanced subject matter expertise of global ... quality standards, cGMP, and external agency regulations to lead preparedness for regulatory inspections and audits at AbbVie sites across the global network. Drives… more
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