- 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, ... collaboration skills.-A strong track record of publications in parenteral drug product development and/or deliveryDemonstrated ability to lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …advanced degree (Master's or PhD) preferred.Minimum of 10 years of experience in medical device or combination product engineering, with at least 5 years ... syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to...technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing,… more
- Merck & Co. (Durham, NC)
- …Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control).- Supply Chain Management:-Manage coordination with ... Position Overview : Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our… more
- Eisai, Inc (Nutley, NJ)
- …scientific literature for potential adverse event reports, report findings to Product Safety within established timeframes. Qualifications: Advanced healthcare ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...within the department and cross-functionally. May serve as project lead to develop and update AMCP Formulary Dossiers for… more
- Merck & Co. (Durham, NC)
- …performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.).-Continuous Improvement - Accountable for ... people. This role as a Manager, Operations will be an energetic, leader with strong interpersonal, leadership, and collaboration skills responsible for supporting… more
- Merck & Co. (Rahway, NJ)
- …and change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and ... Sciences, Phytochemistry, Process Control Automation, Process Optimization, Process Simulation, Product Formulation, Safety Compliance, Standard Operating Procedure… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead , you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in ... and technical risks. You will also oversee External Partners during New Product Introductions and Technical Transfers, ensuring the success of our collaborative… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... want to hear from you. The Director, HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle planning projects focused on the… 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 ... hands-on work in applying regulatory guidance and quality standards related to product release and safety .Current Employees apply HERE Current Contingent Workers… more
- Merck & Co. (Rahway, NJ)
- …and scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the benchtop to current Good Manufacturing Practice (cGMP) ... technology to positively impact patients.The Director of Oral Formulation Sciences will lead a team of scientists and engineers responsible for the formulation and… more
- Merck & Co. (Rahway, NJ)
- …The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The ... will be to maintain all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best practices to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including...provide input for the vision and direction of AI product deployment and governance to ensure responsible and efficient… more
- Merck & Co. (Rahway, NJ)
- …on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMPs) ... SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material… more
- Genmab (NJ)
- …and related patient information) for the Genmab portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence ... and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product… more
- Tris Pharma (Monmouth Junction, NJ)
- …Under direct supervision of the Manufacturing Supervisor and/or Manufacturing Technician Group Lead , provides continuous flow of product and components to all ... (FDA) standards. She/he also provides and monitors the continuous flow of product and components to all manufacturing areas to ensure adequate supplies are… more
- Merck & Co. (Rahway, NJ)
- …the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories (Research & Development) ... regulatory operationsProviding strategic and tactical direction and execution of cross product and GRACS cross functional projects and teams as assigned.Key… more
- Merck & Co. (Rahway, NJ)
- …on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMPs) ... PR&D pipeline. Responsibilities: - Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material… more
- Merck & Co. (North Wales, PA)
- …to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human ... the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of… more
- Eisai, Inc (Exton, PA)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... document review for phase III and PV at CMOs at the company's discretion.5. Lead and assist in troubleshooting upstream and downstream process, product , and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cross functional groups to enable robust production, testing and release of product to patients.Key Responsibilities Provides technical expertise in support of an ... development, implementation and sustainment of emergency response programs and other safety programsAssists in the creation, tracking and completion of metrology… more
