- Merck & Co. (Rahway, NJ)
- …to support investigations related to supplier caused deviations and CAPAs.Integrate Purchasing Control Activities into Integrated Project Plan for each MDCP ... the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in...lead various initiatives in support of our QMS Purchasing Controls and Device Supplier Management objectives and build QMS… more
- Merck & Co. (Rahway, NJ)
- …for commercializing new products.Technical Expertise:Utilize extensive experience in design controls , device transfer, control strategies device risk management, ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role...and complex drug delivery systems. Proven expertise in design controls , risk analysis, control strategies, design verification… more
- Merck & Co. (Durham, NC)
- …and Word, AutoCAD and Business Objects.. Preferred Experience and Skills: Project management, including change control and equipment qualificationSAP experience ... Job Description Position Description: The Associate Director , HVAC & Utilities Engineer is a member of the Plant Engineering team providing technical support to the… more
- Twist BioScience (South San Francisco, CA)
- Director /Sr. Director , Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated ... Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, in-house developed MES solutions… more
- Repligen (Waltham, MA)
- …regulations. This role requires expertise in SEC reporting, US GAAP, and financial controls . The Director will work closely with senior leadership, auditors, and ... OverviewThe Director of SEC Reporting and Accounting is responsible...any changes in SEC regulations that impact reporting requirements.Internal Controls & ComplianceMaintain and strengthen internal controls … more
- Eisai, Inc (Raleigh, NC)
- …objectives and ensure patients have consistent access to medicines. The Director will develop colleagues with expertise in relationship/ project management, ... objectives and ensure patients have consistent access to medicines. The Director will develop colleagues with expertise in relationship/ project management,… more
- Eisai, Inc (Exton, PA)
- …supporting technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing scientific ... Control , Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established and emerging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... data visualizations, external data acquisition and validation, and tools to support project portfolio across drug programs. This role is responsible for ensuring the… more
- Merck & Co. (Durham, NC)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for ... all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong business… more
- Merck & Co. (Rahway, NJ)
- …effective Industrial Hygiene programs through communication tools, training, and project plans.Evaluate, monitor and communicate the effectiveness of Industrial ... risks.Provide support and expert advice to divisions and sites to control Industrial Hygiene hazards for manufacturing, research and office personnel.Conduct… more
- Merck & Co. (Rahway, NJ)
- …should cover management of budget, travel, resources, headcount, processes (and controls ), productivity, quality and project delivery.A complete understanding of ... Job DescriptionThe Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and ... of Cell Culture process development/commercialization for large molecule products.Coordinate project planning, resourcing, progress reporting, troubleshooting and people management.Provide… more
- Merck & Co. (Durham, NC)
- …a successful Validation support of the vaccine manufacturing facilities.The Associate Director , Validation will be responsible for providing Validation leadership as ... team within the Technical Operations organization.Position Responsibilities: Reporting to the Director , Validation the incumbent will lead the team of validation… more
- Twist BioScience (South San Francisco, CA)
- Director , R&D (NGS/Genomics)This role is 100% on-site at our South San Francisco headquarters.The R&D team at Twist is seeking a curious, thoughtful, and driven ... genomics/NGS products, ranging from library preparation kits, enrichment reagents, synthetic controls , and beyond. In this position, you will have the opportunity… more
- Formation Bio (New York, NY)
- …a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities related to biologic product development at Formation Bio. This ... timelines, and support decision-making in biologics development and manufacturing. Project Management Own CMC timelines, budgets, and resources across biologics… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as we embark on shaping our future. The Position The Associate Director , Rare Bleeding Health Care Professional Marketing Experience has overall strategic and ... negotiations and ensures optimal label for pipeline assets Responsible for project management and coordination including overall ownership of launch activities and… more
- Merck & Co. (Rahway, NJ)
- …with a passion for biologics? We're looking for a dynamic and visionary- Director , Drug Substance Leader-to drive innovation and excellence across our Biologics ... documentation of cell culture process commercialization Drive risk assessments, control strategies, comparability reports, PPQ, and regulatory submissions Support… more
- Merck & Co. (Rahway, NJ)
- …all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or ... with governance bodies. -Excellent interpersonal and communication skillsProject Management:-Drive project schedules, set clear priorities, and monitor performance metrics.… more
- Merck & Co. (Durham, NC)
- Job DescriptionThis role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substances.As ... environments complying with current Good Manufacturing Practices in the form of project management and ultimately shop floor leadership.- Key Responsibilities for a… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and ... regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction… more
