- Repligen (San Diego, CA)
- …worldwide. C Technologies, Inc. (CTI) is a Repligen company. The Laboratory Support Specialist is responsible for providing technical assistance and expertise to the ... are commonly used for quantifying concentrations of proteins and antibodies in drug discovery and development, manufacturing, and quality assurance. The Laboratory … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Support Specialist, Sun-Wed 2nd Shift as part of the Technical Operations ... team based in Raritan, NJ. Role OverviewThe Operations Support Specialist will be part of the Technical Operations team responsible for the production of a… more
- Merck & Co. (South San Francisco, CA)
- … drug developer taking advantage of our end-to-end pipeline support in one of the world's most research-intensive biopharmaceutical companies. Responsibilities: ... Clinical Trial Designs, Data Modeling, Data Science, Data Visualization, Drug Development, Modeling Software , Pharmacokinetic Modeling, Pharmacometrics, PKPD… more
- Merck & Co. (Rahway, NJ)
- …accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - Works directly in the SAP system ... s used within the assigned program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug .... - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as… more
- 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 ... applicant will preferably have experience with high concentration biologics to support clinical and commercial development. Maintaining a strong network internally… more
- Merck & Co. (Rahway, NJ)
- …teams (eg Research IT, Informatics) to implement new methods and workflows to support peptide drug discovery across our organization, including physics-based and ... of the art capabilities in predictive sciences, AI/ML and structure-based drug design to accelerate our invention of transformative therapeutics for patients.-We're… 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 ... Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical...finance partners, helps manage use case budgets and forecasts. Support roll up reporting and preparing for budget cycles.Resource… more
- Merck & Co. (Rahway, NJ)
- …data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes ... of our electronic submission process and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data… more
- Merck & Co. (South San Francisco, CA)
- …you passionate about leveraging cutting-edge AI/ML technologies to revolutionize drug discovery and development? The Pharmacokinetics, Dynamics, Metabolism, and ... is seeking a Senior Scientist specializing in AI/ML to support efforts in transforming the way PDMB leads the...in transforming the way PDMB leads the assessment of drug candidates. The successful candidate will join a dynamic… more
- Insmed Incorporated (San Diego, CA)
- …Analytical Development Operations function to build out the process development support testing function within analytical development. Will develop systems and ... team to take care of the operational aspects of analytical testing to support process development to enable rapid development of upstream, downstream and formulation… more
- Merck & Co. (Rahway, NJ)
- …and global human health. Responsibilities :Develops, coordinates, and provides biostatistical support for related drug /vaccine projects under supervision in Late ... clinical trials, and in coordinating the statistical activities for clinical drug /vaccine projects.The incumbent may initially work in a specific disease therapeutic… more
- Merck & Co. (Rahway, NJ)
- …establish a consolidated , visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).- - Responsible for authoring clinical supply ... documentation in support of labeling and packaging activities as well as...- Technical Proficiency: familiarity with supply chain systems and software ( eg SAP or Oracle) and demand planning… more
- Merck & Co. (North Wales, PA)
- …development project as needed. More specifically,-Develops, coordinates, and provides biostatistical support for drug projects under the supervision of ... have a solid knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory… 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 ... clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible for the design and maintenance of… more
- Genmab (NJ)
- …compound/indicationFollow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support ... database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs Support development… more
- Merck & Co. (San Diego, CA)
- …target identification, elucidate mechanisms of target of interests, and support indication expansion strategies.In this exciting role, you will:Develop, implement, ... and execute computational studies to elucidate molecular mechanisms of drug action (MoA), disease pathogenesis, and therapeutic response, leveraging multi-modal… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for EBR development and administration at the Raritan site to support production processing while liaising with other functions including but not limited ... to Tech Support , Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. This individual will support electronic batch record (EBR)… more
- BioAgilytix (San Diego, CA)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... Manager II will lead scientific and operational activities in support of preclinical, clinical, and product release studies for...budgets and resources, and being the expert in using tools/ software relevant to the team.Work closely with clients to… 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
- Genmab (NJ)
- …efforts of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology and ... but not limited to:Leads programming activities while providing hands-on support .Reviews CRFs for adequacy and consistencySupports the establishment and maintenance… more
