- Exela Pharma Sciences, LLC (Lenoir, NC)
- …support of commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy the ... Position Summary:Oversee and lead the validation program for production equipment and... quality and process validation requirements for existing products. Participate in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies.Provide comprehensive quality ... improvement and ongoing collaborations. Provide end to end process consultation impacting products from a quality ...professionals at strategic non-project team and at MA strategic discussions. Lead the Quality Reviews of respective product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the leadership team for consideration of quality and process improvements. Operational Efficiency / Continuous Improvement: Lead knowledge sharing, ... implementation of Data Management departmental strategy and solutions related to process development, improvement, and training. Lead and coordinate development… more
- Aequor (Swiftwater, MN)
- …process control strategies. Provide technical assistance to manufacturing and quality operations for process troubleshooting, improvement, technical transfer ... Preferred Skills: Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to… more
- Merck & Co. (Rahway, NJ)
- …ability to engage key stakeholdersDemonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting ... efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge,… more
- Merck & Co. (North Wales, PA)
- …Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting ... that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe Quality Systems Lead role is an ... (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to the CAPA program for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation ... translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with… more
- Tris Pharma (Monmouth Junction, NJ)
- …(OOT)/Lab Event, Corrective and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, ... Test Results for Pharmaceutical ProductionStrong working knowledge of pharmaceutical investigation process and ability to conduct, lead and/or draft effective… more
- Merck & Co. (Rahway, NJ)
- …DescriptionJob Description The Development and Commercialization Team (DCT) leader is-accountable for delivering a fully-integrated stage-appropriate CMC development ... advancing the company's Antibody Drug Conjugate (ADC) portfolio. Correspondingly, the DCT leader will be responsible for delivering world class outcomes in the… more
- Novo Nordisk Inc. (Durham, NC)
- …activities of shopfloor personnel in accordance with the Novo Nordisk way. The Work Cell Leader / Team Lead will ensure the safe & effective operation of one ... our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate… more
- Aequor (Framingham, MA)
- …with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis. Lead the creation and use of digital process data analytic systems. ... clearance, and leachable and extractables. Understand cGMP concept and familiar with quality and regulatory framework. Proficient in process data analytics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to successful ... products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue and potential solutions to the… more
- Merck & Co. (South San Francisco, CA)
- …as mechanistic experimentation to advance drug discovery from target concept through lead optimization. The candidate will also work closely with therapeutic area ... development and progression. If you are a highly motivated leader and team player with a proven tracker record...cardiovascular diseases to enable a robust drug discovery pipelineDrive hit/ lead finding and lead optimization plans in… more
- Repligen (Clifton Park, NY)
- …identifies areas for continuous improvement and drives those into the process .Compliance with all aspects of Repligen's Quality Management system ... OverviewThis position is for a Production Lead in the Repligen Injection Molding and Packaging manufacturing group. The lead will be responsible for the safe… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position The Rapid Clinical Analytics Lead Data Scientist role sits within the Clinical Data...and storytelling skills. We commit to an inclusive recruitment process and equality of opportunity for all our job… more
- Repligen (Clifton Park, NY)
- …identifies areas for continuous improvement and drives those into the process .Compliance with all aspects of Repligen's Quality Management system ... OverviewThe Extrusion Lead will report to the Extrusion SupervisorResponsibilitiesOperation of a mill to combine starting raw materialsOperation of extruders and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Aseptic Manufacturing LeadPosition Summary:The Aseptic Manufacturing Lead plays a critical role in overseeing aseptic manufacturing activities. A strong background ... microbiology and experience in aseptic manufacturing are required. The Aseptic Manufacturing Lead will actively participate on the production floor by leading a team… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …will work closely with cross-functional teams, including manufacturing, facilities, process engineering, quality , MSAT (Manufacturing Science and Technology), ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...Control Systems) is responsible for acting as a technical lead and trusted advisor, ensuring high availability, optimal performance,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe QC Microbiology Group Lead will report directly to Microbiology management, (ie, QC-Microbiology Supervisor) and will provide both laboratory ... assist leadership in building, leading and developing a group of quality control microbiologists that support the ongoing development, manufacture, and distribution… more
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