- Merck & Co. (North Wales, PA)
- …and post-marketing development stagesDesign, develop and evaluate processes and tools for product safety evaluation, including ongoing aggregate safety ... Management Safety Teams.- Lead and provide statistical support for related drug /vaccine projects in Clinical Safety StatisticsInteract with Safety … more
- Catalent (San Diego, CA)
- Quality Assurance Associate II - Manufacturing Catalent Pharma Solutions in San Diego is currently hiring a Manufacturing Quality Assurance (MQA) Associate II ... regulatory requirements; to advance the development and manufacture of drug candidates. This will include documentation review and approval, dispositioning… more
- Merck & Co. (Rahway, NJ)
- …in our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage ... equipment assembly and disassembly, cleaning, and processing of raw materials into finished drug product . These individuals are expected to partner with and… more
- Merck & Co. (North Wales, PA)
- …to discover the next medical breakthrough.Position Description: The Associate Principal Scientist Statistical Programming leads the statistical programming ... activities for multiple and/or large/complex late stage drug /vaccine clinical development projects.- Accountability predominantly includes the development and… more
- Catalent (St. Petersburg, FL)
- Associate Scientist II, Analytical Research & Development Position Summary Catalent is a global, high-growth, public company, and a leading partner for the ... evaluation and testing of raw materials, excipients, APIs, in-process and finished product samples. AR&D also performs development and validation of methods used to… more
- Catalent (San Diego, CA)
- Quality Assurance Associate I, ManufacturingCatalent Pharma Solutions in San Diego is currently hiring a Quality Assurance Associate I in our QA Manufacturing ... group. A QA Associate I must be familiar with applicable GMPs. This...pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services… more
- Merck & Co. (Durham, NC)
- …is in direct support of our Sterile Supply manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to activities ... functions necessary to allow proper accountability and traceability of product . Maintains, inventories, and transports all required equipment, materials, supplies… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Conduct risk assessments to prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance. Address recurring ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical… more
- Merck & Co. (North Wales, PA)
- …statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the development ... and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of which range from… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Associate OpEx Engineer as part of the Technical Operations team based in Raritan, ... a strong culture that enables robust production, testing and release of product to patients. Key Responsibilities Owns, plans, leads, Develops, drives and executes… more
- Merck & Co. (Rahway, NJ)
- …designing, developing, and scaling up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good ... laboratory to commercial scale, step across boundaries, and implement novel innovations during drug product development to enable the best science at first… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, ... materials management, weigh and dispense, GMP manufacture, formulation development, and bulk Drug Product release.- Close connectivity with upstream Drug … 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 ... on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMPs)… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …sanitation, and documentation activities associated with the production of drug products. This position supports the ongoing development, manufacture, and ... corporate policies, and the regulatory requirements of the US Food and Drug Administration. Job Responsibilities: Perform duties associated with the compounding of… more
- Catalent (Philadelphia, PA)
- …throughout our global network. Packaging can be configured to hold a single product or multiple products as determined by study requirements. We offer manual patient ... Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role Support activities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... to unstructured problems with minimal guidance. This position will mainly support New Product Planning and pipeline assets and responsibilities will cover a mix of… more
- Aequor (Thousand Oaks, CA)
- …sections including the Summary of Clinical Efficacy, Summary of Clinical Safety , Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, ... Table of All Studies, briefing documents, and safety narratives Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... for Harmonisation Guidelines), applicable country regulations (eg US Food and Drug Administration Code of Federal Regulations, Health Canada), and escalating quality… more
- Waupaca Foundry, Inc. (Hardinsburg, KY)
- …castings and has a history of innovation with a legacy of product quality. Waupaca Foundry employs approximately 4,400 people company-wide.Waupaca Foundry is ... equipment repairs and support special projects. RESPONSIBILITIES: Successfully complete safety training, and demonstrate ability to comply with departmental … more
