- Tris Pharma (Monmouth Junction, NJ)
- …to ensure high quality submissions are made to the Food and Drug Administration (FDA) to meet company goals. ESSENTIAL FUNCTIONS Assists and supports the ... updates, potential risks mitigation, etc. Collaborates with appropriate clinical, medical, quality and regulatory counterparts and others across business to… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.GENERAL SUMMARY The Director of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process and develop risk mitigation strategies. Provide quality oversight and strategic quality advice to the CSPV and key business function and collaborate ... business functions. Identify appropriate continuous improvement initiatives for quality and compliance related areas. Oversight Provide strategic direction… more
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager, Engineer or AuditorExperience with drug -device combination ... Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But...Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality … more
- Catalent (St. Petersburg, FL)
- Supplier Quality Regional Lead Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the ... lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based ... in Raritan, New Jersey. Role Overview The Quality Systems Lead role is an exempt level position...sterile GMP environment. This role will serve as the business process owner for the Corrective and Preventive Actions… more
- Merck & Co. (North Wales, PA)
- …events. The data collected from Clinical Trials are used to support drug applications and regulatory submissions to health authorities globally.Trial Data Management ... (TDM) is a core business capability that focuses on technology/process simplification and innovation to:Improve the Clinical Trial experience for our… more
- Merck & Co. (Rahway, NJ)
- …in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and Clinical Supply ... interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with...Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical… more
- Merck & Co. (Rahway, NJ)
- …method development, optimization and transfer of immune- and cell-based assays for drug substance and drug product release, stability, and characterization that ... subject matter expertise related to potency assays for biologicals and new drug modalities.The qualified candidate will be responsible for program potency strategy,… more
- Merck & Co. (Durham, NC)
- …our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. ... local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.This role is within a… more
- Catalent (PA)
- Proposal Lead I Summary Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to ... help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art… more
- Merck & Co. (Rahway, NJ)
- …a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific...to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for… more
- Merck & Co. (Rahway, NJ)
- …This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our company's pipeline to identify ... as the opportunities arise, develop new and novel delivery technologies.These drug delivery device technology platforms are often assemblages of injection molded… more
- Catalent (St. Petersburg, FL)
- …etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of the Quality Unit and could include all or some aspects ... featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …SAP MDG Materials, BOM, Recipes, MRP, MPS, Work Centers, Batch Management, Quality Inspection, Costing among others. Collaborate with business stakeholders, ... Warehouse, Materials Planning, Work Centers, Bill of Materials / Recipes, Costing and Quality Inspection attributes. This role will partner with the IT team and… more
- Merck & Co. (Durham, NC)
- …and provide the best-in-class services with the final goal of delivering our high- quality vaccines to the patients around the world with our core principle of ... Safety First and Quality Always.The Associate Director,... Always.The Associate Director, Engineering/Maintenance will support a new drug substance manufacturing operation's engineering, maintenance, and calibration activities.-… more
- Merck & Co. (North Wales, PA)
- …growth of the US Oncology franchise. The impact of policy on our company's Oncology business is substantial. Much of the success of the business moving forward ... priorities - the Inflation Reduction Act (IRA), state Prescription Drug Affordability Boards (PDABs), and 340B. The ideal candidate...motivate others to action, and drive results with pace, quality , and impact. To put it simply, the successful… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the oversight of and… more
- Merck & Co. (Rahway, NJ)
- …the-development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients, ... with CMC and Regulatory in aspects of control strategy and filings, Quality , and our partners in the commercialization and manufacturing division.This challenging… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to ... global project teams. This role will be a senior member of the Regulatory, Quality and Clinical Reporting (RQC) team, and will provide mentorship and coaching to… more
