- 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
- 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
- Merck & Co. (Rahway, NJ)
- …is business critical that our Company receives consistent, accurate, high- quality data from clinical trials conducted worldwide. In partnership with the Clinical ... oversight of vendors; 2) Development, review and revision of quality agreements with business partners (ie co-development...by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... control and deviation processes at NN Boulder, specifically in the role of Quality Assurance (QA) subject matter expert (SME).This position is also responsible for… 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 (Philadelphia, PA)
- …Philadelphia, PA is hiring a QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors on the production floor, ... incoming material quality , and/or distribution quality , including quality oversight for material management of materials at Catalent-Philadelphia. Assist in… 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
- Catalent (Manassas, VA)
- 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
- Catalent (San Diego, CA)
- Quality Assurance Associate I, ManufacturingCatalent Pharma Solutions in San Diego is currently hiring a Quality Assurance Associate I in our QA Manufacturing ... pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Merck & Co. (Rahway, NJ)
- …company is seeking leadership of our Biologics and Mixed Modalities Drug Product Development teams, responsible for the scientific and technical oversight ... of our small molecule, large molecule, and mixed modalities drug product formulation design, process development, and innovation to establish and maintain a… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …trials, andThe clinical trial operational data component of an enterprise business intelligence application that utilizes AWS and TableauThe Associate Director, ... assigned to other duties as assigned by the Head of Business & Technology Capabilities.Essential Functions/ResponsibilitiesDevelop and lead the execution of… more
- Merck & Co. (Durham, NC)
- …role will contribute to the performance and results of a E2E drug substance/product department and provide technical guidance. Off-shift and weekend coverage will ... be required based on business unit needs during start up and operations, and...support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are… 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
- 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)
- …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)
- …facility which is responsible for interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and ... is building a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) drug substance lab and the Specialist will become a subject matter… more
- Merck & Co. (Rahway, NJ)
- …company's Device Development (DD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… 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
- Aequor (NJ)
- …during phases 1-4. The individual must partner closely with clinical, regulatory, quality and production associates to ensure timely delivery of supplies to study ... regulatory requirements. Monitoring long-term inventory and allocation strategies considering drug recertification, country specific regulatory requirements, international drug… 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
