- Merck & Co. (Durham, NC)
- …to the totality of audit and inspection findings at the site .- Ability to lead an audit program that is focused on early detection and robust remediation of ... Job DescriptionThe Quality Associate Director/GMP Lead Site Auditor will have leadership...using risk-based approaches Schedule and perform assigned audits for site program . Ensure timelines and quality of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD) ... to achieve safe and effective delivery to their intended site of action.- The DPPD Team manages the development...to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within quality systems processes.Key Responsibilities Provide oversight to the CAPA program for the CAR-T manufacturing site .Oversee metrics, trending, and ... 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. Role ... to support global process validation activities in support of the commercial Carvykti program both within Legend but also externally with our program partner… more
- Merck & Co. (North Wales, PA)
- …of patients and global human health. Responsibilities :Serves as a statistical lead in project teams. Lead , develops, coordinates, and provides biostatistical ... support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical, Regulatory, Statistical Programming, Data Management,… more
- Merck & Co. (Rahway, NJ)
- …its customers, and shareholders. The scope of this group includes strategic program management, enterprise strategic planning, risk management, as well as strategic ... Position Description: The Director of Commercial Strategy Development will lead and support strategy development for enterprise-critical commercial initiatives,… more
- Merck & Co. (North Wales, PA)
- …a best-in-class patient experience for IBD patients in support of the launch of our lead asset in immunology. This role will develop a deep understanding of the IBD ... collaborate closely with the US patient support strategy (PSP) lead where relevant, with an aim to ensure the...of IBD launchIdentify key elements of a patient support program to address these gaps in consideration of competitive… more
- Merck & Co. (Rahway, NJ)
- …a key role in the exceptional delivery of our Company's Total Rewards program to employees and their families. The Compensation and Benefits Senior Specialist is ... and communication skills, empathy, and attention to detail.- This role will lead various processes in multiple benefit programs, including our Company's Puerto Rico… more
- Merck & Co. (Rahway, NJ)
- …that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few ... is capable of meeting all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in best auditing practices in order to ensure the inspection readiness level of each site and maintain a capacitation program for GMP staff in best audit ... universe for GMP relevant activities involving but not limited to supplier qualification program , CMC audit, clinical/IMP vendor audits and overall GMP vendor audit … more
- Merck & Co. (Rahway, NJ)
- …with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of ... of assays. Plan assay optimization and documentation to meet program deadlines. - Authoring and reviewing internal technical reports,...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support to ... administration of EBR and digital solutions at the Raritan site to support base business production processing while liaising...also be responsible for establishing and reporting on key project/ program metrics in support of on time and on… more
- Merck & Co. (Rahway, NJ)
- …efficiency and data-driven decision-making. Under the broad guidance of the DSCS Digital Program Mgmt Lead , the Associate Director, DSCS Digital Project Manager, ... seasoned Project Manager with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on helping the team build… more
- Merck & Co. (Montgomery County, PA)
- …treatment for patients suffering with IBD.The marketing strategy role will lead foundational customer strategy and planning for a significant anticipated launch, ... Director HCP PMO to drive foundational customer strategy, leveraging L3 marketing framework. Lead digital and data analytics, customer, and market insights to define… more
- Merck & Co. (Boston, MA)
- …rigorous assessments that can inform leadership decision-making; develop, refine and lead Oncology strategic initiatives across our Company; and help evolve and ... sciences, development and commercialization) to identify capability gaps and ways to evolve- Lead internal and external teams to drive ideas from conception to… more
- Merck & Co. (Rahway, NJ)
- …Sciences colleagues.-Recommends and executes programs of value to the Company which lead to availability of Clinical Supplies and Development Batches to meet ... Clinical Development Program requirements.-Partners with Quality, Operations, Technology, and Financial to...Skills:-The candidate should be able to work independently and lead or facilitate tasks successfully.Strong knowledge of business impacts… more
- Merck & Co. (VA)
- Job DescriptionThe Companion Animal Regional Sales Manager position will lead the Shenandoah Regional Companion Animal sales team to accomplish regional sales goals ... implements a comprehensive region business plan, ensuring consistent product program implementation and sales goal attainment.Directly impacts business unit… more
- Insmed Incorporated (San Diego, CA)
- …in on site Change Control CAB meetings as the CSV lead . Who You Are: Position Requirements (Required and/or Preferred Skills, Experience and Education): ... control, periodic reviews, and audit trail reviews. \tOnsite at San Diego site .What You'll Do: Responsibilities will include, but not necessarily limited to the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead continuous improvement initiatives with various site functions to ... executes against an effective, holistic continuous improvement and problem solving program to improve safety, compliance, cost, process stability building quality… more
- Insmed Incorporated (NJ)
- …corporate objectives.Translate strategy into actionable plans across sites and departments. Lead scenario planning, pipeline mapping, and network design for ... the global Tech Ops master plan and ensure alignment with site -level plans.Identify and drive innovation opportunities across manufacturing, supply chain, and… more
