- Merck & Co. (Rahway, NJ)
- …Knowledge of Regulations/Industry Guidance (NFPA, ATEX, CE, And OSHA)Process And Product Safety TestingReviewing And Developing Safety and ... support business objectives, with focus on Process Design and Process Safety for Small Molecule High Potency/Containment Projects. Develop project scope, front-end… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for the Patient Support programs database Manage IT projects in coordination with IT, Global Safety and Product Safety Management to upgrade and improve the ... functioning of various safety systems Develop and manage project plan and timeline; ensure full alignment across internal and external stakeholders and partners… more
- Eisai, Inc (Nutley, NJ)
- …scientific literature for potential adverse event reports, report findings to Product Safety within established timeframes. Qualifications: Advanced healthcare ... Training to update training programs, and utilize clinical expertise to present product and disease state information to new Sales hires. Contributing to reports… 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. (Durham, NC)
- …Office, Microsoft Office Support, Operations Management, Production Planning, Production Standards, Product Requirements Management, Safety Protocols, Safety ... Practices, Standard Operating Procedures and execute according to established safety standards.-Demonstrates, at all times, safe work habits and maintains… more
- Merck & Co. (Rahway, NJ)
- …and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and ... a vision to develop a team, demonstrated leadership skills, sterile product technical & domain expertise, effective communication skills, understanding of regulatory… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Summary: -The Director, Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization. ... support global and site-specific projects, facilitate technology transfer, and drive product robustness for sustained launch in alignment with the company's business… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPrincipal Scientist - Mixed Modalities, Sterile Product DevelopmentThe Mixed Modalities team within Sterile Product Development is responsible for ... such that the process is scalable without compromising stability, safety , efficacy, and delivery. -During development, we leverage smart experimental… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... (PV) oversight. This role fulfills the PV Oversight for NNI Patient Safety processes and as providing SME-level input from the affiliate perspective when… more
- Eisai, Inc (Phoenix, AZ)
- …Oncologists, Hematologists, Endocrinologists, and nurses, etc. learn about the efficacy and safety of Eisai's product (s) consistent with FDA approved label. ... understanding of issues and opportunities in territory. Deliver clinical, efficacy, and safety messaging and information about product access / safe… more
- Twist BioScience (South San Francisco, CA)
- …the efficient and compliant management of regulatory documentation, with a primary focus on Safety Data Sheets (SDS), product labeling, and SOP's. This role is ... crucial in supporting global product compliance, ensuring that all documentation accurately reflects regulatory... specifications.What You'll Be Doing Initiate, author, and maintain Safety Data Sheets (SDS) for all Twist products, ensuring… more
- Aequor (Hicksville, OH)
- …are operating the lines and handling the material/equipment according to product specifications, reviewing batch paperwork, performing line clearances, setting up ... lot number, expiration date and scans in drums of product . Calculates and documents in Filling Instructions tare weights...and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals. Note: This position may require the… more
- Merck & Co. (Durham, NC)
- …Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control).- Supply Chain Management:-Manage coordination with ... to deliver Pharmaceutical, Biologic, and Vaccine Products. Our team works with a " Safety First, Quality Always" mindset.-As the primary point of contact for all… more
- Aequor (Hicksville, OH)
- …line and monitors for defects. Inspects filled container or package to ensure product is according to specifications. May weigh finished products to detect missing ... line culls and documents all components discarded. Prepares shippers, inspects finished product and packages into shipper. Seals, labels, and stacks shipper. Fills… more
- Merck & Co. (Durham, NC)
- …facility will include end-to-end processing of both drug substance and drug product , including product inspection, warehouse, utilities, and quality control ... Responsibilities:This role reports to an Operations Associate Director and supports the product transfer for a new facility in Durham, NC within Drug Substance,… more
- Aequor (Hicksville, OH)
- …filling and packaging operations. Major Accountabilities Supplies production line with product and packaging components as required. Loads and unloads components or ... product onto or from pallets, trays, racks, shelves and...lines simultaneously. Alerts Supervision, Mechanics and Quality personnel of safety , quality and equipment performance problems when they occur.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both ... Maintains compliance with Global PV regulations for individual case safety and periodic reporting. Contribute as a key DSI...negotiation and transfer of PV Business in case of Product Divestment. Collaborate with DSI audit groups to ensure… more
- Merck & Co. (Durham, NC)
- …people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the ... and clerical functions necessary for proper accountability and traceability of product . - Maintains, inventories, and transports all required processing equipment,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... Interacts closely with Marketing & Patient Support Solutions and NNI Patient Safety . External relationships include interactions with NNI vendors involved in the NNI… more
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