- Merck & Co. (Rahway, NJ)
- …introduction(s) and commercial market(s) approval(s).Define design input(s)/ output(s) and lead associated combination product design verification plan, ... studies at the device component/ subassembly/ in-process material and combination product level. Lead stablishing test methodologies/ testing readiness and… more
- Merck & Co. (Rahway, NJ)
- …Molecule VCM Product Leader (PL) is the end-to-end (E2E) supply chain lead responsible for developing and executing product supply strategies for one or ... for their product (s).- As a result, VCM Product Leaders have direct impact on cost, quality...access, continuity of supply, and commercial outcomes. The VCM Product Leader will lead the cross-functional Supply… more
- Merck & Co. (Millsboro, DE)
- … a high-impact Integrated Process Team that directly influences site performance, product quality and cost-of-goods for life-changing animal vaccines. Your ... to drive operational excellence, develop teams, and deliver measurable results.What you own: Lead and grow the Integrated Process Team (IPT) - coach managers and… more
- Merck & Co. (Rahway, NJ)
- …degree of technical, project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant depth and breadth ... of scientific, technical, and operational experience to lead and support facility operations, process development activities, compliance investigations/change… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Warehouse Operations Shift Lead as part of the Technical Operations team based in Raritan, NJ. Role ... OverviewThe Warehouse Operations Lead will be part of the Technical Operations team...warehouse space. Assist in regulatory inspections, perform safety and quality audits, and answer relevant questions about packaging, methods,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …potential suppliers, manage RFI/RFP and term sheet development, and negotiate contracts. Lead cross-functional teams and collaborate with Quality , Legal, CMC, ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Category Sourcing Lead as part of the Global Operations team based in Raritan, NJ. Role… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. ... within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight...occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2) ... leadership in clinical trials, clinical sciences, medical monitoring, target product profile (TPP) development, due diligence projects, and clinical-regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes creation of ... label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality Assurance… more
- Aequor (Cincinnati, OH)
- …organic inspections, sampling, food safety physical and documentation audits, and finished product pathogen testing. Like all Quality department professionals at ... Job Title: Food - Quality Technician Location: Cincinnati, OH 45241 Duration: 03... notifications in SAP for defective materials or packaging Lead the plant sensory program, documentation, and gold standard… more
- Insmed Incorporated (NJ)
- …through Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including ... and continuous improvement initiatives across development programs.Responsible for final product Quality release/rejection and related processes.Support supplier… more
- MetroPlusHealth (New York, NY)
- …you do every day.About NYC Health + HospitalsMetroPlusHealth provides the highest quality healthcare services to residents of Bronx, Brooklyn, Manhattan, Queens and ... relationships with its members and providers.Position OverviewThe Director of State Product Compliance, reporting to the Vice President of Compliance, plays an… more
- Insmed Incorporated (NJ)
- …departments to ensure external QC activities align with project timelines and product lifecycle needs.Establish quality and delivery KPIs for contract labs. ... for the future of science, we're in. Are you?About the Role:The Associate Director, Quality Control will be responsible for leading and overseeing all Quality … more
- Merck & Co. (Durham, NC)
- …drug product , including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. -Key Duties:2nd Shift ... preferably with biological drug substanceEnd-to-end processing of drug substance, drug product , lyophilization, product inspection, and quality control… more
- Merck & Co. (Rahway, NJ)
- …production direct reportsEnsure that shift objectives are achieved while reliably supplying quality product at a competitive cost consistent with all applicable ... per procedures or need.-Supply - Exercise judgement and decision making to ensure quality product is reliably produced while managing cost. Responsible for… more
- Merck & Co. (Rahway, NJ)
- …approaches, and strong industry and FDA connections to our company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and ... delivery of high- quality submissions for products that may include respiratory/ inhalation,...other regulatory authorities. This role will also be a lead and advocate for digital innovation and leveraging it… more
- Merck & Co. (Rahway, NJ)
- …procedures.This position is based at the Rahway, New Jersey site.Primary Responsibilities: Lead the execution of microbiology finished product testing, utilities, ... GMP environmentExpertise in nonsterile and aseptic manufacturing and associated GMP product testingExperience in leading and supporting quality investigations in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of successful Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality representatives, and ... Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality execution across Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Patient Safety Call Center, Intake and Triage, Customer Care Call Center, Product Quality /Technical Complaints, Patient Safety Organization Call Center Vendor. ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …seek out, anticipate, and solve significant scientific and technical challenges. Lead complex investigations into technical challenges related to design, ... coach and mentor others to grow their technical rigor to lead and/or contribute to investigations and resolutions.Cross-Functional Collaboration:Act as the primary… more
