- Insmed Incorporated (Bridgewater, NJ)
- …maintain Standard Operating Procedures relating to areas of responsibility including product release, design control , etc.Act as company's representative during ... not necessarily be limited to, the following: Responsible for final product Quality release/rejection and related processes.Partner with other Regional Quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …working on a multidisciplinary pharma/diagnostic development team. preferredKnowledge of design control , market and product requirements management, and the IVD ... development process preferredKnowledge of molecular diagnostics technology, competitors, and market space preferredEstablished expertise and hands-on experience with Microsoft Project, Word, Excel, PowerPoint, Outlook, SharePoint and remote meeting tools such… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Quality Control Associate will serve as a strategic and tactical quality professional ... including starting materials, in-process, release, and stability testing throughout the product lifecycle. This position will not have direct reports This role… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position is responsible for the overall quality of materials subject to Product Material Review Process (PMRP) - including but not limited to: Brand ... Markets sales tools, speaker slide decks, Website materials, advertising and New Product Planning materials. This individual will be an integral member of the… 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 ... the GTL has accountability that far exceeds its direct span of control which require very strong cross-functional leadership abilities. The role reports to… more
- Merck & Co. (Rahway, NJ)
- …descriptionThis position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device ... subject-matter experts on the DD team and members of internal cross-functional product development teams from concept through product launch.- Additionally, the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategies for cleansing and standardizing data, with a focus on eg, clinical, product , and vendor data and Identify and rectify data anomalies, inconsistencies, and ... o Security and protection of organizational data assets o Access Control leveraging administrative controls of data access rights for cross-functional users… more
- Merck & Co. (Rahway, NJ)
- …of the Company and compliance with all governing regulations.Responsibility for Quality Control functions including oversight for product testing, as well as ... change control oversight, metric review, and review of annual product reviews. This also includes providing support to build effective quality systems… more
- Insmed Incorporated (Bridgewater, NJ)
- …management processes. Drive implementation of key program documentation - Target Product Profile Strategic Development plans, Dashboards, Risk assessments and other ... managed. Work with respective functional leaders to drive the creativity of innovative product target profiles and product development plans that optimize value,… more
- Merck & Co. (Rahway, NJ)
- …of outages that can impact our operations.The engineer will also work with the Print Product Manager to adopt and set a vision, roadmap, manage the backlog and set ... with our IT and business goals. The engineer will also work with the product manager to establish our incident and support framework.The nature of the position… more
- Merck & Co. (Rahway, NJ)
- …Alliance Managers, and Governance Managers navigate Research & Development product development lifecycles, Research & Development pipeline governance processes, and ... processes and overall user experience for our clients across the planning and control ecosystem.Under the broad guidance of the Executive Director, Head of our… more
- Merck & Co. (Rahway, NJ)
- …but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including upstream, analytical, and secondary ... (JMP or Design Expert software).Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT)… more
- Merck & Co. (Rahway, NJ)
- …with application to drug substance and a broad array of drug product dosage forms, combination products and modalities through analytical characterization, imaging ... tools of the-future.- Author investigational new drug (IND), investigational medicinal product dossier (IMPD), and new drug application (NDA)/ worldwide marketing… more
- Merck & Co. (Rahway, NJ)
- …applicable guidance for the production of clinical GMP drug substance, drug product and packaged goods across all modalities to ensure worldwide clinical supplies ... vial filling, and lyophilization, and supporting clean utilities.Familiarity with change control systems and Quality assessment of change in a current Good… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an exempt level position responsible for reviewing all data produced by the Quality Control Lab during In-Process and release Drug Product QC Testing, related to ... a biological and/or pharmaceutical industry is required. Experience in a Quality Control setting is preferred. Knowledge of cGMP and GDP regulations and FDA/EU… 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 ... inspection, and disposition of all incoming materials for use in CAR-T product manufacturing per inspection plan and record results to complete receipt process.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Develop positive relationship with the QA team, Quality Control , Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, ... and peers. Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel. Independently makes appropriate 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 for cell ... approve relevant QC documents, logbooks, SOP's and WI's. Ensure microbiological control strategy is consistent with cGMP requirements. Participate in training and… more
- Scotiabank (New York, NY)
- Manager, US Investment Banking Product Control **Requisition ID:** 197379 **Salary Range:** 85,700.00 - 159,100.00 _Please note that the Salary Range shown is a ... results, in an inclusive and high-performing culture. **Manager, US Investment Banking Product Control (197379)** **Global Banking and Markets** Global Banking… more
- SMBC (Jersey City, NJ)
- …SMBC offers a competitive portfolio of benefits to its employees. **Role Description** The Product Control team seeks an experienced Product Control ... + 2 - 4 years of combined experience in financial services or product control . Big 4 financial services audit experience preferred but not required. + Bachelor's… more
