- Aequor (Bothell, WA)
- …of materials, drug substance in intermediates, governed by SOP's.The Inventory Control Associate will also assist in overseeing inventory control and ... Program, track and download temperature monitors as required by the business. Inventory control and maintenance of drug substance, raw materials, disposables and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to communicate the issues and support resolution development.Support IRT design for control of drug dispensing and inventory management. Understand User ... playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations. Work is escalated if outside of scope of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Document Control Lead role is an exempt level position with...status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free… more
- Novo Nordisk Inc. (Boulder, CO)
- …is seeking a highly experienced and dynamic professional to manage parenteral drug product manufacturing, and corresponding CMC regulatory activities. The Manager of ... Drug Product Manufacturing is accountable for clinical phase 1...Work effectively across all departments, such as Quality Assurance/ Control , Chemical Development, Program Management, Regulatory, Quality Control… more
- Merck & Co. (Durham, NC)
- …will include end-to-end processing of both drug substance and drug product, including product inspection, and quality control laboratories.The Specialist, ... providing technical support as part of one of the drug substance or drug product Technical Operations...of one of the drug substance or drug product Technical Operations teams.Position Responsibilities:Reporting to the Technical… more
- Merck & Co. (South San Francisco, CA)
- …and network-based approaches to elucidate molecular mechanisms of disease progression and drug response to drive target discovery and drug development efforts ... This Exciting Role, You WillContribute to multiple stages of Oncology drug discovery to decode genetic dependencies and identify targetable cell-surface antigens… more
- Merck & Co. (Rahway, NJ)
- …science, and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global ... to characterize and release raw materials, package components, clinical drug substance, and clinical drug product for...parts of the AR&D organization in aspects of quality control and compliance. Your main responsibilities will include: -… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for performing a wide range of activities to support the release of drug products for human use. This position is responsible for quality and maintaining ... procedures, and all applicable regulations.Key Responsibilities Manage the team responsible for drug product batch record review and drug product release… more
- Merck & Co. (Rahway, NJ)
- …DescriptionAs part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences ... support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.Adaptability and… more
- Merck & Co. (Rahway, NJ)
- …include development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients, ... It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …data and documentation generated from the Environmental Monitoring program, drug product and intermediates testing from the manufacturing facility utilized ... and approve relevant QC documents, logbooks, SOP's and WI's.Ensure microbiological control strategy is consistent with cGMP requirements.Participate in training and… more
- Merck & Co. (Rahway, NJ)
- …such as residual and PCR-based assays).Strong background in analytical control strategy development and execution.Demonstrated ability to develop talent through ... of actions.Experience in analysis of various Biologic modalities (eg, mAb, antibody- drug conjugate, fusion protein).Knowledge and experience in Antibody Drug … more
- Aequor (Waltham, MA)
- …batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical ... clinical trials Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations. Ensure that… more
- Eisai, Inc (Raleigh, NC)
- …audit readiness, support regulatory inspections, manage complaints effectively, oversee change control , review metrics, and conduct annual product reviews. This also ... of global GxP and regulatory requirements related to the drug development process.Significant experience with manufacturing operations, biologics, and aseptic… more
- Tris Pharma (Monmouth Junction, NJ)
- …Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.The incumbent uses ... and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in global forums/ team meetings, mentor site users for audit process, and control access to any systems used to support audits/inspections.Provide support to quality ... citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free workplace. more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Oversee the efficient and timely release of patient-specific, finished drug product batches by collaborating with all functions (including Quality ... Assurance, Quality Control , Operations, Vein to Vein, Batch Advocate Team, etc.)....status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free… more
- Eisai, Inc (Raleigh, NC)
- …activities for a global Brand. This position will monitor and issue orders for Drug Product (DP) and Drug Substance (DS), ensuring accuracy of supply sites, ... for manufacturing use based on expiration dating.Assists with change control /updates to materials using Trackwise.Supports month end close process, reconciling… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with Quality, Manufacturing Operations, Facilities & Engineering Quality Control , Operations Technical Support, Supply Chain and PlanningRequirementsA minimum ... citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free workplace. more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …MES, including EBR design, troubleshooting, and optimization.Provide technical expertise of Change Control process as well as oversight of the MES team to ensure ... citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free workplace. more
