- Merck & Co. (Rahway, NJ)
- …for interpretation of potency data in context of broader process and product development, control strategy, and specifications-setting.-Deep working knowledge of ... regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses and interacting with Health Authorities.Ability to effectively manage a portfolio of projects, multi-task in a highly dynamic environment,… more
- Insmed Incorporated (Bridgewater, NJ)
- …Engineer at Insmed position reports directly to the Director of Product Quality Complaints. The primary responsibilities include managing QA Compliance activities, ... Deviations/CAPA/EC documents. Monthly/Quarterly Metrics reporting, SOP updates, and conducting product complaint investigations, including communication with patients for troubleshooting… more
- Merck & Co. (Rahway, NJ)
- …portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species. About the ... Position The Animal Health IT Customer Master Data Management (MDM) Product Owner collaborates with stakeholders across all levels of the organization, from senior… 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
- Merck & Co. (Rahway, NJ)
- …technologies.Responsibilities:Assist in the design, implementation, and optimization of process control systems to improve production efficiency and product ... in troubleshooting and resolving technical issues related to process control systems, instrumentation, and equipment.Support commissioning and startup activities for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionResponsibilities:Develop product vision and roadmaps that enable QE to deliver on its strategies.Work with various business, technical, and vendor ... QE leadership - to discover opportunities and coordinate with other product owners to deliver solutions using Agile methodologies.Collaborate with systems engineers,… 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)
- …will engage the clinical, Medical Affairs and commercial organization and drive the product evidence strategies to ensure an effective use of HEOR and RWE methods. ... the role will contribute with HEOR sections in target product profiles (TPPs), product development plans, clinical...as early economic models, burden of illness studies, external control arms to support single arm trials, and drive… more
- Tris Pharma (Monmouth Junction, NJ)
- …supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures ... and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations,… 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)
- …methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients, and packaging components ... 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 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
- Merck & Co. (Rahway, NJ)
- …Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our ... for analytical development of candidates from the discovery interface, through first product registration.- -The Director will be directly responsible for a team of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reporting and analysis needs - Inclusive of development of processes, control and best business practices around data management. Build organization understanding ... base. Manage and support all site-specific projects with respect to new product launches, alternate material sources, alternate BOM/recipes, etc. and collaborate on… 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
- Tris Pharma (Monmouth Junction, NJ)
- …and tertiary packaging components in the full cycle scope of product launch and life cycle management. The incumbent participates in assessment/conceptualization, ... (Research and Development (R&D), Supply Chain, Marketing, QA, Quality Control (QC), Regulatory, Packaging, project teams, etc.); Collaborates closely with… more
- Merck & Co. (Rahway, NJ)
- …as required. Create and manage lockout/tagout and hazardous energy control procedures.- Support mechanical aspects of clinical operations, including ... Maintenance and Management Systems (CMMS). Knowledge and experience of sterile drug product manufactureSAP Training and skills - Project Manager (PM) role, SAP Plant… more
- Insmed Incorporated (Bridgewater, NJ)
- …confidential matters with discretion and judgment.Manages workload and work product to support Manager efficiently and in a solution-oriented manner.Excellent ... Commercial practices of a US business.Understanding of compliance internal control concepts and framework.Maintains understanding of laws and regulations,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …products Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories. Perform peer review/approval of ... within a biological and/or pharmaceutical industry is required Experience in a Quality Control setting is preferred Experience with aseptic processing in ISO 5 clean… 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 systems team, ad hoc, for activities such as annual product review, site risk register, or internal quality agreements. Develops and delivers training for… more
