- Merck & Co. (Durham, NC)
- …project management and ultimately shop floor leadership.-Key Responsibilities for a Drug Product Operations Manager Accountability - Project SupportFirst-line ... Carolina. The new facility will include end-to-end processing of drug substances, drug products, including biotech culture...the design and construction of the facility, the Operations Manager will play a critical role in supporting the… more
- Catalent (Manassas, VA)
- …to help create engaging new products consumers will love.The Procurement Manager is responsible for procurement leadership, sourcing and procuring materials, ... services, and capital for the site. The Procurement Manager will lead site procurement team and initiate and...through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Cardiometabolic Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare ... through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role,...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Take responsibility to ensure meeting logistics,… more
- Catalent (TX)
- Job Description Manager , Contract Management The Manager , Contract Management serves as a strategic business partner to our Business Development and Legal ... organizations. The Manager , Contract Management will support the development and execution...rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring… more
- Catalent (Harman, WV)
- The Manager , Supply Chain - Warehouse , reporting to the Director, Supply Chain, has an opportunity to make a significant impact on the way that the Harman's site ... operates. The Manager , Supply Chain - Warehouse will lead a shift...rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the...rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of ... reporting of clinical trials. preferred- Having knowledge of all phases of drug development, including early and late phase clinical development and submission… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...simultaneously Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. Drive continuous… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation, design and leadership of clinical development plans, and addressing all regulatory, drug and patient safety , data, CMC, IP, patient selection, market ... processes.Providing proactively regular strategic and tactical status updates to their manager and governance on progress, risks, opportunities and challenges, and… more
- Aequor (San Diego, CA)
- …RNA isolations, Western blot, qRT-PCR, Flow Cytometry) Experience with high-throughput drug screening is a plus. *Job Description: This Associate Research Scientist ... in San Diego. The incumbent will be responsible for drug screening, cell-based assay development, and biomarker discovery. The...with other scientists May involve presentation of data to manager and project team Thoughtful review of data and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …personnel. Additionally, you will implement testing standards, policies and ensure safety measures are followed. The supervisor will assist laboratory personnel with ... performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate… more
- Catalent (St. Petersburg, FL)
- …schedule for the QA Specialists.Provides feedback to QA Supervisor and Manager on performance of QA Specialists.Responsible for actively identifying compliance ... Review Board) presentation.Effective communication with Quality Assurance Supervisor and Manager regarding status of daily work.Serve as administrator (or back-up)… more
- Merck & Co. (Durham, NC)
- …and procedures.- Responsible for establishing processes that ensure required safety guidelines are followed.- Review and approve qualification/validation documents ... ability to meet performance objectives. Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements. Support manufacturing investigations, create/revise ... forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, provide input on… more
- Catalent (NJ)
- …as assigned.The Candidate Proven, successful track record as sales executive or brand manager in a leading company operating in the cosmetic industry, minimum 3 ... rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …all data produced by the Quality Control Lab during In-Process and release Drug Product QC Testing, related to the manufacturing of cell therapy products for ... SOP's and WI's. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a project manager , project lead, or similar role within pharmaceutical drug development desirablepreferred TravelAbility to travel up to 10% Global travel might ... (AESI) educational materialsThis role works cross-functionally to collect / update safety and treatment information that is ultimately provided to educate patients… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with all applicable regulations and ... investigations based on potential impact on product quality, patient safety , and regulatory compliance. Address recurring deviations and health authorities'… more
