- Merck & Co. (Durham, NC)
- …to meet immediate business objectives even through adversity. This role will support drug product in regulated, clean room environments complying with current ... management and ultimately shop floor leadership.-Key Responsibilities for a Drug Product Operations ManagerAccountability - Project SupportFirst-line operations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Product Release: Manages the execution of assigned responsibilities within the commercial drug product and IMP release program to assure all external ... product quality/GMP support and assures proper documentation of drug product release programs in accordance with internal procedures. Support proactive… more
- Catalent (St. Petersburg, FL)
- …applicable product development experience required and direct pharmaceutical drug product development experience preferred. Bachelor's degree in ... product development experience required and direct pharmaceutical drug product development experience preferred. Associate's in Pharmacy/Pharmaceutical… more
- Aequor (Thousand Oaks, CA)
- …management skills Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques General knowledge of ... this vital role, you will provide support to the Product Quality (PQ) organization as a subject matter expert...as a subject matter expert of clinical and commercial product stability studies and GMP data management. In this… more
- Merck & Co. (Durham, NC)
- …for the patients who need it. The facility will include end-to-end processing of drug substance, drug product , including biotech culture growth, harvest, ... for the position includes all aspects of Quality oversight for drug product , drug substance, media preparation, and sterile supply.Position… more
- Merck & Co. (Rahway, NJ)
- …with respect to device component manufacture and final assembly of biologic/ drug product with device constituent part.Lead/support the development, ... years of leadership experience with deep working knowledge of device, biologic/ drug product , and process development including regulatory submission and… more
- Merck & Co. (Rahway, NJ)
- …and late-stage development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility ... and supporting regulatory filings.Build deep fundamental knowledge around the drug product to ensure completion of key milestones and laboratory /… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product , or New Modality) Lead is ... management of technology transfer of the manufacturing processes of (mAb, Drug Substance, Drug Product , or New Modality) for investigational and commercial… more
- Aequor (Thousand Oaks, CA)
- …techniques used for protein molecule product quality control? Understanding of drug substance and drug product development and manufacturing? Strong ... and data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for a ...Product Quality Director is the champion for a product team as the Product Quality Leader… more
- Aequor (Seattle, WA)
- …This position also manages post-transfer life cycle activities to support Cell Therapy Drug Product Programs. Other accountabilities might be included for the ... of method lifecycle and method maintenance programs to support cell therapy methods ( drug product or as applicable). End to end management for method transfer &… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to ensure personnel are following proceduresPerform QA inspection of finished drug product units and samples for release/stability testingManages reject ... cage for rejected finished drug productsRetrieves finished drug product sample requests and delivers them to requestorAdminister/ prepare inspector… more
- Lundbeck (Bothell, WA)
- …of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on ... programs with a focus on methods to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is responsible for QA GMP activities pertinent to the overall compliance state of DS drug substance, drug product and packaging manufacturing sites of DS ... customer, DS affiliates and DS HQ's in order to ensure the quality of drug products marketed globally and acts as a global partner to successful drive QA… more
- Aequor (Bothell, WA)
- …with specifications and SOPs. 2. Inspects and releases intermediates or packaged drug product per specifications. 3. Monitors various stages of processing ... Maintains shop floor quality presence; disposition in-process materials and finished product ; investigates and resolves GDP errors; Performs batch record reviews.… more
- Aequor (Seattle, WA)
- …and support development of manufacturing processes, and/or QC release of the drug product . The successful candidate must have extensive hands-on experience ... Experience with proteins characterization preferred Position Summary: Cell Therapy Product and Analytical Development (P&AD) is seeking an enthusiastic, self-driven… more
- Merck & Co. (Durham, NC)
- …This role will contribute to the performance and results of a E2E drug substance/ product department and provide technical guidance. Off-shift and weekend ... operations;Ensure that Shift(s) objectives are achieved while reliably supplying quality product at a competitive cost consistent with our Company, Regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …microbiology data and documentation generated from the Environmental Monitoring program, drug product and intermediates testing from the manufacturing facility ... citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. Legend Biotech maintains a drug -free workplace. more
- Merck & Co. (Rahway, NJ)
- …(PSCS) organization is responsible for translating a therapeutic agent into a functional drug product optimized for patients and for ensuring the availability of ... and project team meetings to provide a broad perspective on the drug development process in the pharmaceutical industry.-Work Experience Experience/Skills We are… more
- Merck & Co. (Rahway, NJ)
- …development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of a variety ... of reagents, solvents, and active pharmaceutical ingredients during "wet chemistry" operations (performing chemical reactions, extractions, distillations, crystallizations, filtration, drying, etc.) as well as dry powder processing (eg, dry milling). Ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reviewing all data produced by the Quality Control Lab during In-Process and release Drug Product QC Testing, related to the manufacturing of cell therapy ... citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. Legend Biotech maintains a drug -free workplace. more
