- Catalent (St. Petersburg, FL)
- Manager , QA ( Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... include all or some aspects of the Quality function.The Product Development QA Manager provides quality focused...rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at ... Product Batch Release, and Change Control.The QA Product Manager provides customer service, with the...rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring… more
- Eisai, Inc (Nutley, NJ)
- …tracking, documenting and processing adverse event reports received for assigned product , including the timely review and distribution to co-marketing partners and ... up of adverse event reports that potentially impact the safety profile of product area responsibility. Interacts with staff at other Eisai and co-marketing partner… more
- Insmed Incorporated (Bridgewater, NJ)
- …qualification/validation, transfer and characterization for drug substance, drug product and reference standards. The Manager must possess a good ... degradation products, reference standard qualification and physical (solid-state) characterization of drug product and drug substance.Prepares and approves… 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 ... skills.Preferred Experience and Skills:Demonstrated knowledge of MPS/LeanUpstream / Fermentation Drug Substance/ Product start-up experienceDemonstrated experience of interacting… more
- Tris Pharma (Monmouth Junction, NJ)
- …or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug -device combination products ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems… more
- Catalent (St. Petersburg, FL)
- …capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug ... to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer.… more
- BioAgilytix (Durham, NC)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in ... drive a process automation platform solution for a best-in-class CAR-T product Development of an automation concept through detailed execution ,planning activities,… more
- Novo Nordisk Inc. (Virginia Beach, VA)
- …Team leads the US sales efforts for Novo Nordisk's robust cardiometabolic product portfolio, which includes world class therapies for the treatment of diabetes, ... budget and business plans. This is an entry level district business manager position. Relationships Reports to the Regional Business Director. Manages a regions… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is the GPT Leader, directly accountable for conceiving, designing and implementing product development strategy and delivery for their asset(s). The GTL has ... design and leadership of clinical development plans, and addressing all regulatory, drug and patient safety, data, CMC, IP, patient selection, market acesss and… more
- Novo Nordisk Inc. (Boulder, CO)
- …method development and transfer of methods for oligonucleotide intermediates (IPC's) as well as drug substance and drug product release within a nonGMP lab. ... batch analyses for manufacturing of oligonucleotides Provide analytical support for drug product formulation studies, including osmolality, viscosity, HPLC, UV… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a more senior project manager in support of a larger, more complex drug development project. As a project manager this position is accountable for partnering ... disorders. Summary This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic development… more
- Catalent (St. Petersburg, FL)
- …has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.II. Basic Function: This position is ... responsible for managing and documenting events / discrepancies associated with either product or process as well as managing / writing any investigations that may… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
- Insmed Incorporated (Bridgewater, NJ)
- …activities associated with delivering on Insmed's assets through completion of the drug development and launch processes. This position will be accountable for all ... management processes. Drive implementation of key program documentation - Target Product Profile Strategic Development plans, Dashboards, Risk assessments and other… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …release of materials required for manufacturing and release of patient material/final product of CAR-T at Raritan, NJ Legend manufacturing site. Key Responsibilities ... disposition of all incoming materials for use in CAR-T product manufacturing per inspection plan and record results to...handling tasks in a backup role, as needed. Updates supervisor/ manager of work status or problems with recommendations for… more
- Merck & Co. (Rahway, NJ)
- …Alliance Managers, and Governance Managers navigate Research & Development product development lifecycles, Research & Development pipeline governance processes, and ... include: Key Responsibilities PMO owner and steward of "Development Project Manager " user persona; accountable for defining business process user stories and… 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 ... the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager when data discrepancies are identified. Job duties performed may… more
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