- Merck & Co. (Millsboro, DE)
- …fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for audits, inspections, validations and ... Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly...excellence, develop teams, and deliver measurable results.What you own: Lead and grow the Integrated Process Team (IPT) -… more
- Merck & Co. (Durham, NC)
- …priorities and schedules project/work meeting the criteria established by site objectives. Support & lead Utility equipment related projects, scope including ... is a member of the Plant Engineering team providing direct hands on technical support to the Durham Site.- The site includes an Energy Center, Vaccines DP and… more
- Merck & Co. (Durham, NC)
- …role and will serve on the Operations leadership team. Key responsibilities of the Lead Technician include direct support of operations on the production floor, ... 6:30 PM; 6:00PM-6:30AM) rotation ( 2-2-3).- - The Vaccine Manufacturing Facility Lead Technician is an excellent opportunity for highly motivated individuals with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support /input into commercial and market access discussions for select indications.- Support as medical lead for select company-sponsored GMA evidence ... of the Senior Director/Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical… more
- Merck & Co. (North Wales, PA)
- …and compliance processes, and leading high-impact cross-functional teams.Responsible to lead or support -complex technical projects and/or equipment technology ... introduction, product source change and/or device component source changes.The incumbent will lead or support complex global and site-centric capital and… more
- Merck & Co. (Rahway, NJ)
- …and works in close collaboration and alignment with the Value and Implementation lead . Support the Regional Directors Medical Affairs and other medical ... Cycle Management decisions leveraging patient and healthcare country insights Support business development assessments by validating unmet medical needs, reviewing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration with business functions. Provide expert guidance to enable successful inspections. Lead / Support local inspections by providing adequate systems and ... process support , ensuring seamless execution. Lead lessons learned efforts based on audit findings, inspection results, regulatory intelligence, effectiveness… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in Raritan, NJ. Role OverviewThis position will be responsible for providing project lead support for strategic initiatives and capacity expansion activities at ... capacity ramp up to meet clinical and commercial demand.Drive capacity evaluations and lead action implementation to support site ramp up plans.Monitors capacity… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review meetings and ... will be responsible for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile… more
- Merck & Co. (Rahway, NJ)
- …for maintaining appropriate levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide.- Under the guidance of the ... Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …readiness activities.Responsibilities:This individual will be the main point of contact and support all signal management activities. They will lead the safety ... a particular signal(s) to ensure compliance with global Sops. Lead the maintenance of signal tool and support... Lead the maintenance of signal tool and support tasks of change control, training material update, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to lead the implementation of companion diagnostics (CDx) in support of multiple projects within Daiichi Sankyo's Oncology Late-Stage Development Portfolio. The ... to account for external shifts. Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs, and in support of pre-launch, launch… 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 ... (BPR&D). The incumbent will support GMP capability build for the production of clinical...engineering resource for biologics operations, build strong equipment knowledge, lead projects, and provide guidance and training to operationalize… more
- Merck & Co. (Durham, NC)
- …opportunity to experience licensure and ramp up to full production.Durham's Lead Technician, Operations will be a leader with strong interpersonal, communication, ... manufacturing process. This individual will possess the ability to lead a team, train others and contribute to and...and contribute to and implement process improvements.This position will support the purification of the drug substance of our… more
- Merck & Co. (Durham, NC)
- …role of Assoc. Director, Engineering.- This role will provide end-to-end support of manufacturing science and technology for commercial vaccine products including ... Virus Vaccine (LVV) team. The successful candidate will provide technical leadership and support for LVV franchises, with potential to support ERVEBO and/or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Category Sourcing Lead as part of the Global Operations team based in Raritan, NJ. Role ... innovation, pioneering work and evolving best practices.The Global Sourcing Category Lead is responsible for leading global sourcing activities for direct materials… more
- Merck & Co. (Durham, NC)
- …projects in their operational area-Represent Operations on project teams as needed-- Communication- Lead and support daily (Tier) meetings to facilitate flow of ... This individual must actively manage their assigned team to reliably support customer demand (including hiring as needed, employee development, routine 1:1… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or she will interact with counterparts in the Companion Diagnostics group to support the program. Other responsibilities will include but not be limited to ... clinical protocols, and in the submission of certain regulatory documents. Support commercial in developing a strategy including patient selection strategy.-… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Manufacturing Lead Operator as part of the Technical Operations team based in Raritan, ... Good Manufacturing Practice (cGMP) cleanroom environment.Independently execute manufacturing or manufacturing- support processes according to standard operating procedures and current… more
- Repligen (Clifton Park, NY)
- …issues.Develop and implement PM schedules, calibration plans, and equipment operation SOPs. Lead or support facility and equipment projects from planning ... preventive maintenance programs, equipment optimization, vendor coordination, and quality support , while serving as a technical subject matter expert...as a technical subject matter expert (SME) and team lead . The position also plays a key role in… more
