- Merck & Co. (Rahway, NJ)
- …accordance with US and WW regulations, company policies and standard operating procedures.The Senior Director of Clinical Supply Systems (CSS) is a key member of the ... and translating strategic priorities into integrated operational team activities.- The Senior Director of CSS will also ensure measurable and sustainable results… more
- Merck & Co. (Rahway, NJ)
- …existing and pipeline products to produce safe, effective, innovative medicine.The Senior Principal Scientist/ Senior Director is responsible for protocol ... and preparation of manuscripts for publication in peer-reviewed journals. The Senior Director will also contribute to establishing Vaccine Clinical Development… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... and process development using semi-automated and automated equipment, conduct functional testing , assist in clinical batch manufacture as an equipment subject matter… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …IT teams to ensure a strong data and technology foundation Engage senior leaders to drive strategic technology transformations Physical Requirements 10-20% overnight ... based applications. Extensive knowledge in prompt engineering, including implementing and testing prompts to ensure GenAI model interacts correctly within the… more
- Repligen (Waltham, MA)
- OverviewWe are seeking a highly skilled and motivated Senior Cell Culture Scientist to join our Advanced Bioprocess Applications R&D team. This role will focus on ... and Tangential Flow Depth Filtration (TFDF) technologies, as well as testing new filters, systems, and process analytical technologies. Experience with mammalian… more
- Merck & Co. (Rahway, NJ)
- …digital solutions and emerging technologies. - Coordinate and conduct UAT testing activities - Monitor and evaluate the performance of digital initiatives, ... tracking key metrics, and providing recommendations for continuous improvement. - Mon ito r data quality and a dministrative activities related to IT solutions - C reate release notes for system enhancements in a clear and concise manner to ensure end users… more
- Eisai, Inc (NJ)
- …to version releases, system updates, validation or user acceptance testing , and integrations with other clinical applications through change management.Maintains ... MS OfficeEisai Salary Transparency Language:The base salary range for the Senior Manager, eTMF System is from :114,600-150,500Under current guidelines, this position… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are looking for a Senior Software Engineer, Applied AI to join our dynamic team at Formation Bio. ... Azure). Familiarity with model evaluation techniques, including cross-validation, A/B testing , and confidence-based ranking. Experience building multi-agent AI systems,… more
- Merck & Co. (Rahway, NJ)
- …of the Client Audit Director (CAD) and the Auditor-in-Charge (AIC), the Senior Specialist will:Participate in the execution of financial, operational, SOX 404 and ... work.Execute audit programs and work papers (including walkthroughs and sample testing ) in line with the established quality standards and timelines.Collaborate with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and configuration deliverables related to business processes. Conduct user acceptance testing and provide training and support to end users. Participate with ... internal IT data teams/vendors to understand data integrations and API requirements (no development experience required) in and out of Veeva CRM system.- Documentation: Document various system related documentations such as system configurations, data flow… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and CDx submission plan for each country/region, both before and after CDx testing , for less complex projects.At the time of implementation of a CDx study/IVDR ... performance evaluation study integration of an assay into clinical testing (before testing ) and once data is...and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel:… more
- Merck & Co. (Rahway, NJ)
- …and - expectations. Participate and support the goals and objectives of the GCTO Senior Leadership - Team (SLT) or extended Leadership Team (eLT). Speak with "one ... Quality Managers, to deliver objectives. Collaborate with Functional Service Provider (FSP) Senior Leadership to ensure adequate and - appropriate resourcing for our… more
- Merck & Co. (Durham, NC)
- …standards of quality and in compliance with all regulatory requirements. -The Senior Specialist, Quality Assurance will support ongoing efforts to supply the market ... manufacturing.Position ResponsibilitiesReporting to the Associate Director, Technical QA, the Senior Specialist, QA Technical will independently manage assignments related… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description The Senior Scientist, Device Design Control Lead, is a crucial member of our team, responsible for spearheading design control efforts ... through launch and post-market surveillance. Key Responsibilities and Activities: The Senior Scientist, Device System - Device Design Control will be responsible… more
- Merck & Co. (Rahway, NJ)
- …clinical development pipeline. The role will need to interact effectively with senior leaders within our Company's Global Clinical Development (GCD) division to ... License:NoHazardous Material(s):N/ARequired Skills:Adaptability, Adaptability, Business Management, Change Management, Clinical Testing , Commercial Contract Negotiations, Communication, Contract Negotiations, Cost Controls,… more
- Repligen (Waltham, MA)
- …operations.Lead the SOX compliance program, including risk assessments, documentation, testing , remediation, and reporting.Collaborate with senior management and ... company Lead SOX risk assessments, audits, and remediation efforts Partner with senior leaders to embed strong controls into business processes Mentor and develop… more
- Merck & Co. (North Wales, PA)
- …for the benefit of patients and global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), ... Business, Clinical Data, Clinical Databases, Clinical Site Management, Clinical Testing , Clinical Trials, Coaching, Communication, Computer Science, Data Analysis,… more
- Cepheid (Miami, FL)
- At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing . Our mission drives us, every moment of every day, as we develop ... every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As… more
- Novo Nordisk Inc. (Durham, NC)
- …within the Stability and Support Teams. Additional responsibilities includes ensuring testing of in-process, release, and stability samples are performed in ... role is onsite. Monday - Thursday 10 hr day shift schedule. Relationships Senior Manager. Essential Functions Lead team in successful execution of QC and Stability… more
- Leica Biosystems (Miami, FL)
- …about the Danaher Business System which makes everything possible.The Senior Histotechnician, Quality Control, is responsible for developing and implementing ... testing , sampling, and inspection procedures on raw materials, equipment,...the maintenance of laboratory facilities, equipment, and consumables.Perform additional testing and investigation related to customer complaints, nonconformances, and… more
