- Merck & Co. (Rahway, NJ)
- Job DescriptionPrincipal Scientist - Mixed Modalities, Sterile Product DevelopmentThe Mixed Modalities team within Sterile Product Development is responsible for ... development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for… more
- Merck & Co. (Rahway, NJ)
- …is seeking a dynamic and versatile leader for External Manufacturing Operations , Drug Delivery Systems and Devices within our Manufacturing Division (Associate ... role serves as a Virtual Plant Manager - responsible for leading a cross -functional team in oversight of our relationship with External Partners that manufacture,… more
- Merck & Co. (Rahway, NJ)
- …business value. This role will initially focus on the Global Clinical Trial Operations (GCTO) functional area, with the growth potential to contribute to other ... areas. You will collaborate closely with-Business Leaders & Development IT Product Line Leads to define technology solutions for priority business problems,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …internal DS plants are meeting DSI supply needs across the entire product portfolio.ResponsibilitiesManage the development of all packaging plans for CMO's based on ... forecast and current inventory levels across all product portfolios. Manage the creation of production plans for...requests. Support the data collection for the Sales and Operations Planning (SOP) process.Execute the processes required to update… more
- Merck & Co. (Rahway, NJ)
- …Management Office (PMO) within GPAM enables pipeline progression and cross -functional execution by integrating planning capabilities, data science / engineering, ... our Project Managers, Alliance Managers, and Governance Managers navigate R&D product development lifecycles, R&D pipeline governance processes, and annual R&D… more
- Merck & Co. (Rahway, NJ)
- …program(s). The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie ... balancing needs of patients & ensuring stable supply of product . Primary activities include, but are not limited to:--Interacts...clinical supply planning and incorporate them into the team's operations . - Focus on Customers & Patients. - Make… more
- Merck & Co. (Rahway, NJ)
- …CCIT testing capabilities for our clinical portfolio in various product images (vial, syringe, medical delivery device, bulk/flexible/rigid containers).- This ... support where needed.Primary ResponsibilitiesLead AR&D CCIT strategy for pipeline product development.Responsible for validating and performing CCIT for clinical… more
- Merck & Co. (Rahway, NJ)
- …with clinical development plans. Collaborating with Discovery, Translational Medicine and Product Development Teams, you will be the authority in defining and ... Vice President Precision Medicine and Diagnostics/TA Vice President and cross -functional partners to define Precision Medicine strategy within the Immunology… more
- Merck & Co. (Rahway, NJ)
- …systems, and data.The Associate Director will collaborate and interact with cross -function teams to identify opportunities for improvement and tackle challenges, ... balancing effective operations with transformative initiatives.- The Associate Director, Quality System & Compliance will support to integrate the Device Supplier… more
- Merck & Co. (Rahway, NJ)
- …developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) ... - - Primary Responsibilities: - Propose new, innovative approaches for product development, generate experimental designs, execute experimental plans , and interpret… more
- Merck & Co. (Rahway, NJ)
- …modern digital solutions for research and development and plant operations , platform development using modern architecture, building end-to-end solutions to ... deploy operational solutions that span the scientific, executional, compliance, and operations spaces. - Your responsibilities will include develop and maintain… more
- Merck & Co. (Rahway, NJ)
- …authority, navigating complex or matrix organizations and working successfully with cross -functional teams Preferred Knowledge and Skills: Product launch or ... stakeholders to drive and align on decisions, including field sales, marketing operations , Legal, Regulatory, Medical, etc.Our US marketing team has adopted an Agile… more
- Merck & Co. (Rahway, NJ)
- …activities to ensure a smooth and clear path to successful GMP operations and BLA filings for the company's pipeline.Leads and/or supports program-specific cell ... transfer, long term storage stability, qualification and licensure. Ensure that process/ product are developed and documented according to standard company practices.… more
- Formation Bio (New York, NY)
- …lead all Chemistry, Manufacturing, and Controls (CMC) activities related to biologic product development at Formation Bio. This is a strategic and execution-focused ... team; foster a culture of ownership, innovation, and accountability. Cross -Functional Collaboration & External Partnerships Partner closely with analytical… more
- Tris Pharma (Monmouth Junction, NJ)
- … Product Quality Complaints (PQC) documentation, compliance efforts, quality operations , etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA, as ... Preventive Actions (CAPAs) and Continuous Process Improvements (CPIs)Works directly and cross functionally throughout company (ie, QA Operations , Quality Control… more
- Merck & Co. (New York, NY)
- …Scientific Leaders (SLs). The role provides balanced, factual, scientific information about non- product areas of interest to the company and replies to scientific ... to achieve study milestones. Upon request from Global Clinical Trial Operations (GCTO). Recommends study sites and identifies potential investigators to participate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking a Metrology Support Specialist as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for ... of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an Automation & Controls Technician (Contractor) as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible ... of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require systems… more
- Eisai, Inc (Nutley, NJ)
- …and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support, creates, and communicates clinical study timelines. Gathers ... input from cross -functional teams and creates plans that help the team...and vendor teleconferences as applicableReview regulatory packet for investigational product releaseProvide user access management support ; tracking certifications… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in Raritan, NJ. Role OverviewThis individual will work within Technical Operations responsible for executing plans supporting Raritan end-to-end Supply Chain, as ... and deliverables of goods and services aligned with scope of work.Monitor product life cycles and alert appropriate team members to any actionable inventory… more
