- Merck & Co. (Millsboro, DE)
- Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality ... for life-changing animal vaccines. Your leadership will shape manufacturing systems and release processes that enable reliable, efficient vaccine production… more
- Merck & Co. (Durham, NC)
- …that make our products. We work in the manufacturing plants with a "Safety First , Quality Always" mindset striving for continuous improvement. We work in the ... plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.- Position Description - This… more
- Merck & Co. (Rahway, NJ)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an industry leader in… more
- Merck & Co. (Upper Gwynedd, PA)
- …on existing Data & Analytics (D&A) products and link usage to business outcomes. Lead data transformations, data quality , data governance, advanced analytics, and ... SDLCManaging diverse projects and processes within GCTO/MAP Teams.Champion data quality , integrity, and reliability by designing and promoting best practices.Bridge… more
- Merck & Co. (Rahway, NJ)
- …research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections.Profound knowledge and ... Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head...clinical development programs, clinical trial processes as well as quality management systems and quality … more
- Merck & Co. (Durham, NC)
- …that make our products. We work in the manufacturing facility with a "Safety First , Quality Always" mindset, always striving for continuous improvement. We work ... plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.The Maurice R. Hilleman… more
- Insmed Incorporated (San Diego, CA)
- …leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on ... employees, and everything we do is motivated by a patients- first mentality. We are dedicated to growing our team...represented in current SOPs is essential.Broad knowledge of risk-based quality systems approaches consistent with ICH E6… more
- Merck & Co. (Durham, NC)
- …projects to ensure the Durham Bulk and Formulation/Filling facilities operate Right- First -Time in a cost-effective manner, and to ensure on-going Technical Transfer ... problem solving with other Technical CoE groups, Operations, and Quality . The successful candidate will be expected to be...The successful candidate will be expected to be a first responder to requests from the manufacturing areas when… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and ... Systems COE the Director, Logistics and Distribution Technology will...for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics… more
- Merck & Co. (Rahway, NJ)
- …of 6 years of experience in pharmaceutical development, device development, device systems operations, quality management, or a related area. Strong knowledge ... Job DescriptionJob Description The Senior Scientist, Device Design Control Lead , is a crucial member of our team, responsible for spearheading design control efforts… more
- Merck & Co. (Durham, NC)
- …management). Additionally, they must become proficient in the use of manufacturing systems and knowledgeable of site procedures in order to resolve process/equipment ... issues, minimize downtime, and ensure product quality .--This role will support manufacturing activities at the Durham Site. Successful candidate(s) will be assigned… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... testing and qualification and leading execution of qualification of complex systems .-The candidate is expected to build inclusive, collaborative partnerships with… more
- Merck & Co. (Rahway, NJ)
- …seek out, anticipate, and solve significant scientific and technical challenges. Lead complex investigations into technical challenges related to design, ... coach and mentor others to grow their technical rigor to lead and/or contribute to investigations and resolutions.Cross-Functional Collaboration:Act as the primary… more
- Merck & Co. (Rahway, NJ)
- …Estimation and Planning, Maintenance Supervision, Management Process, Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems , Regulatory ... Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS… more
- Merck & Co. (Rahway, NJ)
- …of scientists and engineers who are responsible for delivering robust packaging systems for cell banks, drug substance, drug product, and finished goods.- ... the design, characterization, qualification, and tech transfer of robust packaging systems to commercial sites, as well as packaging process co-development with… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition description:- Lead the statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development ... in ensuring that project plans are executed efficiently with timely and high- quality deliverables.Serve as the statistical programming point of contact and knowledge… more
- Merck & Co. (Rahway, NJ)
- …cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends ... tight timelines, in a rapidly changing environment.Experience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed… more
- Repligen (Clifton Park, NY)
- …as they relate to Repligen's manufacturing operations. Supervise and support all Quality , Environmental, Health and Safety policies. Lead shift meetings, provide ... Friday, 7:00pm - 3:30am, or 8:00pm - 4:30am. *Training period will be on 1st shiftRepligen offers an extensive line of Corporate benefits and perks with the company… more
- Merck & Co. (Rahway, NJ)
- …and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality , and Supply Chain from early development through to commercial ... and information to others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in the best interest of… more
- Insmed Incorporated (San Diego, CA)
- …This role will be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data quality , compliance, and efficiency ... Lead the setup, development, and validation of EDC systems , including configuration settings, integration with other applications, and...GCP, 21 CFR Part 11, and CDISC ODM StandardsData Quality & Compliance:Ensure EDC systems comply with… more
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