- Merck & Co. (Rahway, NJ)
- …team is responsible for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates and Small Molecules, including ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and ... the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - Works directly...- Technical Proficiency: familiarity with supply chain systems and software ( eg SAP or Oracle) and demand planning… more
- Formation Bio (New York, NY)
- …is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses… more
- Merck & Co. (Rahway, NJ)
- …global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality ... data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes… more
- Merck & Co. (South San Francisco, CA)
- …team focused on bringing AI/ML approaches to bear to improve the speed and quality of decision-making in drug discovery and development. PDMB aims to leverage ... you passionate about leveraging cutting-edge AI/ML technologies to revolutionize drug discovery and development? The Pharmacokinetics, Dynamics, Metabolism, and… more
- Merck & Co. (San Francisco, CA)
- …of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and Clinical Supply ... interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with...Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical… more
- Tris Pharma (Monmouth Junction, NJ)
- …and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, including ... timely closureAssists and trains lower level scientistsIdentifies appropriate instrumentation and software programs to improve MV lab capabilitiesCreates MV SOPs, as… more
- Merck & Co. (Rahway, NJ)
- …:Develops, coordinates, and provides biostatistical support for related drug /vaccine projects under supervision in Late Development Statistics. --Interacts ... clinical trials, and in coordinating the statistical activities for clinical drug /vaccine projects.The incumbent may initially work in a specific disease therapeutic… more
- Insmed Incorporated (San Diego, CA)
- …Development Team representative as an Analytical Lead for a drug program.Key Responsibilities:Responsibilities include developing and optimizing analytical methods ... various spectroscopic equipment. This involves assessing properties of AAV drug candidates and troubleshooting technical issues. Contributes to method qualification… 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 ... that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming… more
- Merck & Co. (Rahway, NJ)
- …. - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related topics ... , visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).- - Responsible for...- Technical Proficiency: familiarity with supply chain systems and software ( eg SAP or Oracle) and demand planning… more
- Merck & Co. (North Wales, PA)
- … and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC) US and/or worldwide drug or vaccine ... : This position supports statistical programming activities for late stage drug /vaccine clinical development projects. This may include leadership of one or… more
- Repligen (San Diego, CA)
- …are commonly used for quantifying concentrations of proteins and antibodies in drug discovery and development, manufacturing, and quality assurance. The ... testing, reporting and customer interactions.Document activities on the CTI/Repligen CRM software platforms & deliver all post-visit findings to appropriate internal… more
- Merck & Co. (Rahway, NJ)
- …of regulatory activities with cross- product or cross-functional impact, including drug device/combination products and software as medical device platforms.- ... efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.Build strong partnerships with Manufacturing, Warehouse, ... Engineering, and Quality , and work as part of a cross-functional team...industry.Proficient computer skills to be able to navigate specialized software and databases.An ability to build strong partnerships and… 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 of reagents, ... writing and the use of word processing, spreadsheet, graphing, and presentation software .This role requires working on a fixed (steady), 8-hour overnight 3rd shift… more
- Genmab (NJ)
- …consistency and adherence to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for decision making. ... are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions with the above… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …etc.).Coordinate and execute MES validation activities according to the Software Development Lifecycle (eg commissioning test Plans (CTP), Installation/Operational ... with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build the Site Readiness of MES for FDA… more
- Total Action for Progress (TAP) (Roanoke, VA)
- …AND PURPOSE : Perform professional work in conducting energy audits and quality control inspections and performing duties as the Crew Leader when necessary ... scheduling as directed by the Director of ECHR Perform Quality Control Inspection of completed jobs for all areas...training and subject to data entry into the agency's software as part of the Whole Family approach and… more
- The Stratagem Group (Aurora, CO)
- …75% on average): Hands-on Development: Actively participate in the software development lifecycle, contributing high- quality , well-tested, and maintainable ... career opportunity now! Position Overview: This position is for a Staff Software Engineering Manager . ARKA-Mission Applications is seeking a talented and motivated… more
