- Merck & Co. (Rahway, NJ)
- …rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead, Oncology Global Clinical ... Job DescriptionOur Clinical Development teams manage studies to provide the safety...PDT Lead will manage the entire cycle of clinical development , including development strategy, study design, initiation,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Mixed Modalities team within the Sterile Product Development is responsible for developing parenteral dosage forms (injections, implants, ... Chemistry, Biochemistry or related discipline Required Experience and Skills :Deep drug product development expertise with exposure to all stages and aspects of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP) Development of clinical sections of trial-level regulatory documents ... (eg, DMC, Endpoint Committee, SC, Ad boards).TPP and EPP (Expected Product Profile) development in collaboration with peer functions and CSOversight of Academic… more
- Merck & Co. (Rahway, NJ)
- …in delivery efficiency and quality.Lifecycle Management and Compliance:Oversee the entire product development lifecycle from conception to deployment, ensuring ... Services' primary responsibilities include, but not limited to :Vision and Strategy Development :Define the product line vision and strategy in collaboration with… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... The incumbent will also have to demonstrate domain expertise in sterile product development and collaborate effectively with multiple stakeholders across both… more
- Merck & Co. (Rahway, NJ)
- …division.This challenging position requires deep understanding of new commercial product development and commercialization, proactively identifying risks to ... science with 10 years of industrial experience with pharmaceutical drug substance and/or product development .Ph.D. in chemistry or related science with 7 years… more
- Merck & Co. (Rahway, NJ)
- …of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our ... planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of... of candidates from the discovery interface, through first product registration. They will be responsible for a portfolio… more
- Merck & Co. (Rahway, NJ)
- …years of experience in project management or a related role required - Product development experience required ; in a pharmaceutical/biotech industry preferred - ... Job Description Job Description: - The drug development Project Manager is part of Global Project...Project Manager, is a core member of Early Drug Development and/or Late Drug Development Teams, partnering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Project Teams including strategic development and execution of an integrated product development plan. This position is accountable for partnering with the ... strategy development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing… more
- Merck & Co. (Rahway, NJ)
- … and Commercialization Expertise :- Proven experience in small molecule product development , commercialization, and supply, including comprehensive knowledge of ... strategy that aligns with enterprise goals. Ensure the successful transition of drug product candidates from development to commercialization to supply.- Talent … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plan, budget and CDP. Lead (or have subordinates lead) cross-functional product decisions including approach for tech development , manufacturing network ... in a global company).10+ years of expertise in project management, process, product , and/or analytical development activities and oncology project development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4 or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project ... defined based on the project needs and the respective development stage of the project. The CMC Lead will...transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and… more
- Merck & Co. (Rahway, NJ)
- …compound(s)/ program(s). The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting ... and for supporting all protocol and program cost estimates requested by Product Development Teams.- Responsible for authoring clinical supply documentation in… more
- Merck & Co. (Rahway, NJ)
- … development related meetings (i .e., Clinical Trial Team s ) and product development related meetings . The incumbent must have demonstrated understanding of ... E2E product development process & connectivity between functions supporting pipeline (ie clinical development , CMC, supply chain, & human health), and… more
- Merck & Co. (Rahway, NJ)
- …strong candidate for the position of Principal Scientist (R5) within the Biologics product development group. Primary duties: Be a seasoned biologics product ... supporting regulatory filings. Have deep fundamental knowledge around large molecule drug product development and have management responsibilities for a small… more
- Merck & Co. (Rahway, NJ)
- …Responsibilities:Responsibilities:Lead development of new, innovative approaches for product development , generation of experimental designs, execution ... scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the bench top to the Good...responsible for leading CMC project teams and the formulation development of new chemical entities through a matrix team… more
- Merck & Co. (Rahway, NJ)
- …related to price, value and affordability challenges at the appropriate time of product development and launch. -Partner closely with the cross functional team ... including marketing and Product Development Teams (PDTs), (ex. clinical, CORE and medical affairs), regional and country teams to ensure patient access… more
- Merck & Co. (Rahway, NJ)
- …to be able to lead and problem-solve across a wide variety of project, product , design, development and related topics. A driven, hands-on, and energetic ... Transformation Lead, the successful candidate will have responsibility partner with the product managers and business stakeholders to develop business as well as… more
- Merck & Co. (Rahway, NJ)
- …tracking, and communicating regarding submissions and approvals to support continued product supply.Participate - in early and late development programs, ... with an advanced degree) in pharmaceutical, medical device or combination product research, development and/or manufacturingExperience in CMC regulatory (IND,… more
- Merck & Co. (Rahway, NJ)
- …with global scientific leaders and key decision makers. The EDMA partners with Product Development Team leaders and Global Brand leaders. They collaborate with ... Research through the global Value and Implementation TeamPartners with the Product Development Team, Global Brand and V&I Outcomes Research leads to define… more
