- Repligen (Waltham, MA)
- …the biotechnology industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,... Network Leader , Chromatography & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend standards, procedures ... treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality ...and cGMPs.Collaborate with site personnel to provide guidance and determine resolution for… more
- Merck & Co. (Millsboro, DE)
- … lead a high-impact Integrated Process Team that directly influences site performance, product quality and cost-of-goods for life-changing animal vaccines. ... inclusive culture focused on continuous improvement.Be accountable for IPT performance against site and division goals, including quality , safety, delivery, cost… more
- Merck & Co. (Durham, NC)
- …and Burgwedel, Germany. The successful candidate will partner with the team Technical Product Leader as well as site Technical Operations and other key members ... technical forums and maintenance of product historical knowledge and best practices. Lead complex process investigations, including multi- site coordination and… more
- Merck & Co. (Durham, NC)
- …and Burgwedel, Germany. The successful candidate will partner with the team Technical Product Leader as well as site Technical Operations and other key members ... manufacturing network: build and maintain strong and trusting relationships with site technical operations, quality , regulatory, stability, and other… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.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 exempt level position with responsibilities...oversight to the CAPA program for the CAR-T manufacturing site .Oversee metrics, trending, and reporting of relevant quality… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionApplications are sought for a Process Engineering Lead position in o ur Reseach & Development Division Biologics Process Research & Development ... Generation Biologics (NGB) facility at our company Rahway, NJ site . By integrating leading-edge technology with a dynamic, activity-based...ur Reseach & Development Division project team as a leader at the detail design phase in preparation for… more
- Merck & Co. (Durham, NC)
- …the unique opportunity to experience licensure and ramp up to full production.Durham's Lead Technician, Operations will be a leader with strong interpersonal, ... work in the manufacturing facility with a "Safety First, Quality Always" mindset, always striving for continuous improvement. We...employees over the last several years; currently the Durham site employs 1,000+ people.The Durham site is… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Development and Commercialization Team (DCT) leader is-accountable for delivering a fully integrated stage-appropriate CMC development and ... will be responsible for advancing the company's biologics portfolio.Correspondingly, the DCT leader will be responsible for delivering world class outcomes in the… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.- Position Description - This is a… more
- Advanced Recruiting Partners (Durham, NC)
- …supporting regulatory submissions and agency interactions. Key Responsibilities Provide on- site Quality support for cross-functional initiatives and product ... Overview The QA Manager will serve as a key member of the Quality team, working closely with cross-functional groups to oversee contract manufacturing organizations… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …individual will partner with Plant Leadership and various Technical Operation and Quality functions in support of personalized cell therapy production through safe ... project plans across functional teamsDefines the interdependent deliverables and ensures that quality , risk, cost, time are managed within the overall approved plan… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational ... quality activities within the assigned therapeutic area.- This includes...levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide.- Under the guidance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Specifications, and Qualification Protocols) with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS ... be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the… more
- Merck & Co. (Durham, NC)
- …daily priorities and schedules project/work meeting the criteria established by site objectives.Support & lead Utility equipment related projects, scope ... quality without compromising superior customer service. FUNCTIONAL EXPERTISE: Lead in the identification and implementation of process improvement projects,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a strategic and technical leader with expertise in cell culture commercialization. The primary objective of the Biologics Drug ... post-market commercial manufacturing biologics. For commercial programs, activities include site -to- site process transfers, manufacturing investigations and trend… more
- Merck & Co. (Durham, NC)
- …the unique opportunity to experience licensure and ramp up to full production.Durham's Lead Technician, Operations will be a leader with strong interpersonal, ... work in the manufacturing facility with a "Safety First, Quality Always" mindset, always striving for continuous improvement. We...employees over the last several years; currently the Durham site employs 1,000+ people.The Durham site is… more
- Merck & Co. (Rahway, NJ)
- …campus planning initiatives.-Manage development of feasibility, programming studies, and site selections for capital projects with external consultants and Our ... Company stakeholders. Lead selection, onboarding, and coordination of outside design and...from minor renovations, repositioning, and new building construction to site development. This includes guidance on campus and building… more
- Merck & Co. (North Wales, PA)
- …introduction, product source change and/or device component source changes.The incumbent will lead or support complex global and site -centric capital and ... as the above- site packaging and assembly equipment SME.- Individual will lead or provide direct technical support to the packaging network in areas of… more
