- Merck & Co. (Rahway, NJ)
- …early adoption of novel process technologies.Contribute to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams ... reputation through conference participation.Represent BPR&D as a downstream bioprocess expert/co- leader in internal and cross-functional project teams.Supervise,… more
- Merck & Co. (Rahway, NJ)
- …early adoption of novel process technologies.Contribute to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams ... reputation through conference participation.Represent BPR&D as a upstream bioprocess expert/co- leader in internal and cross-functional project teams.Supervise,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global QMS (RD PV QA) and is a member of the leadership team. Lead an enterprise cross-functional QA team to deliver state-of-the-art data-driven solutions.Design a ... for operational and technical oversight of QA across GxP (GCP/GVL/GCLP/GLP) systems. Lead the development of the global Data Integrity strategy and promote… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written skills, analytical, organizational,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation, ... regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the methodology, approach, and… more
- Merck & Co. (Rahway, NJ)
- …organization grouped into centralized categories and regional operating teams.The Senior Specialist, NA Transportation Procurement is an integral role that ... team. The role will report into the NA Transportation Procurement Lead . Primary Responsibilities: Category management ensuring compliance with the procurement… more
- Merck & Co. (Rahway, NJ)
- …to save and improve lives. IT Strategy Realization's (ITSR's) purpose is to lead value-driven outcomes and accelerate how we transform IT. Business of IT (BIT) ... and portfolio management, finance, resource planning and IT master data management.The Senior Specialist of Demand and Capacity Management Solution Architect plays a… more
- Merck & Co. (Rahway, NJ)
- …DescriptionJob Description The Development and Commercialization Team (DCT) leader is-accountable for delivering a fully-integrated stage-appropriate CMC development ... advancing the company's Antibody Drug Conjugate (ADC) portfolio. Correspondingly, the DCT leader will be responsible for delivering world class outcomes in the… more
- Merck & Co. (Rahway, NJ)
- …candidates from development to launch in line with enterprise priorities.-As the DCT leader , the Technical Product Leader (TPL) in our Manufacturing Division ... Technical Depth and Breadth of Experience :- Recognized as a credible technical leader through demonstrated scientific excellence in at least one CMC function and… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls ... with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC team; foster a culture of ownership, innovation, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of vendors to support training priorities.Will be expected to serve as the lead with the vendor & project management requirements for initiative completion.Will ... to deliver the materials.Will be required to partner with Senior Training Leadership in the identification and selection of...training priorities. Will be expected to serve as the lead with the vendor & project management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and ... the needs of the overall development plan agreed to by the Global Project Team (GPT). Lead site selection and site qualification discussions, kick-off meetings… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the designated programs.Ensure proactive representation of Quality professionals at strategic non- project team and at MA strategic discussions. Lead the Quality ... to create and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient and effective organization… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … project management, writing and analytic skillsMust be organizational leader with ability to influence others and collaborate cross functionally.Must have ... resources for key programs. The role will also provide senior safety leadership and guidance on complex issues across...a meaningful impact on clinical development at the program level. Lead projects to enhance processes within CSPV, including the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders.SummaryThis role is responsible for partnering with DS internal senior stakeholders to lead , assess, develop, negotiate, and execute ... to optimize and enhance efficiencies and ways of working.Takes ownership and project manages a high volume of high-level projects which involves working with… more
- Merck & Co. (Rahway, NJ)
- …and early adoption of novel process technologiesContribute to strategic initiatives; partner with senior leaders to set overall project strategy, and guide teams ... Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across DS group including business units, functional units and corporate functions. Lead Training function team and Document and record management function team ... record management principles for Global GxP activitiesResponsibilitiesTraining Function Team Lead development of strategies for the needs assessment, design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to ... in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as UK and Switzerland. CDx RA Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and ... (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to...(HAs) during review of device submissionsIn collaboration with CDx lead work with Dx partners to ensure robust development… more
- Merck & Co. (Rahway, NJ)
- …and Development: Lead , mentor, and develop the leadership team, including Senior Directors, Directors, and Associate Directors, to enhance their capabilities and ... as combination product stewardship for inline products. The Executive Director will lead multiple functions in the department of approximately 50 employees, spanning… more
