- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part ... (s)BLA submissions. Evaluate various regulatory mechanisms that allow optimization of product development (eg, orphan drug designation, breakthrough therapy… more
- Merck & Co. (Rahway, NJ)
- …Research & Division organization of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early ... Job Description Job Description: - The drug development Project Manager is part of Global...& Development pipeline and realize its full potential. The Associate Director is expected to provide project… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... IDMP ISO standards for identifying medicinal products and WHO Drug DictionaryMaintain pharmaceutical product reference data (non-company)Qualifications:Education:Degree… more
- Genmab (Plainsboro, NJ)
- …implemented, and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part ... IT R&D Digital Products Team. This role will be reporting to the Director of Engineering and Solution Architecture, R&D Digital Products. The Solution Architect will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global Engineering Solutions (GES), the Associate ... growing portfolio of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development ... will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton,… more
- Merck & Co. (Rahway, NJ)
- …accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s).-Works directly in the SAP system ... forecast for all products used within the assigned program(s) (ie Bulk Drug Product ).--Oversees all bulk drug supply management and ensures proper allocation… more
- Merck & Co. (Rahway, NJ)
- …and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, ... laboratory to commercial scale, step across boundaries and implement novel innovations during drug product development to enable best science at first filing for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , CMO Operation as part of the Global Manufacturing and ... vein team (V2V) to plan, schedule and track the manufacture of autologous cell product batches at CMOMonitor the progress of product batches, identify and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to ... and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC development plan.-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the development ... scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO/vendor proposal and… more
- Merck & Co. (Rahway, NJ)
- …functional impactProactively identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics, conducting ... team is responsible for the research and development of sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral… more
- Merck & Co. (Rahway, NJ)
- …and applying rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global ... Clinical Research group and in the field of breast cancer. The Executive Director , PDT lead will manage the entire cycle of clinical development, including… more
- Merck & Co. (Rahway, NJ)
- …and manufacturing to manage clinical development projectsAssist the Senior Director , Associate Vice-President/Vice-President and Product Development ... Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving… more
- Merck & Co. (Rahway, NJ)
- …Attributes and Quality by Design principles, and advanced data analysis for drug development applications.-The Director selects, trains, and effectively works ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position… more
- Bristol Myers Squibb (Summit, NJ)
- …there's no better place than here at BMS with our Cell Therapy team. The Associate Director , Drug Product External Manufacturing QA provides Quality ... Review, Lot disposition to support the clinical and commercial release of Drug Product . This role will also develop and manage the collaboration and governance… more
- Merck (Rahway, NJ)
- …Research & Division organization of our company. ** ** **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early ... **Job Description** **Job Description:** The drug development Project Manager is part of Global...& Development pipeline and realize its full potential. The Associate Director is expected to provide project… more
- Bristol Myers Squibb (Princeton, NJ)
- …strategic initiatives. **Position Summary** Support the development and execution of Drug Development's (DD) Innovation strategy in partnership with DD Leaders, ... The role will require experience with Innovation, emerging technologies, product development / roadmaps, transformational / change leadership, and executive… more
- Merck (Rahway, NJ)
- **Job Description** **Position Description:** Reporting to a Technology Director or Associate Director in Global Engineering Solutions (GES), the ... Associate Director will be part of a high performing team,...knowledge transfer. Candidates with significant experience in engineering design ( Drug Substance, Drug Product , Plant… more
- Capital One (New York, NY)
- Sr Director , Experience Design Research - Enterprise Developer, Associate and Accelerator Design Capital One's Experience Design (XD) organization creates ... memorable, meaningful customer and associate experiences that build our brand with humanity and...The goal of Experience Design Research is to accelerate product teams' learning velocity. We do this by conducting… more
