- Merck & Co. (Rahway, NJ)
- …& Technology (DD&T) organization designs, develops, and commercializes novel biologic/ drug / vaccine - device enabled combination products to achieve safe and ... set direction for the device development strategy for multiple drug -device combination product development programs ranging from concept generation/selection,… more
- Merck & Co. (Rahway, NJ)
- …to high-volume clinical and commercial assembly equipment and processes for medical devices/ drug delivery systems . Reporting to the Director responsible for this ... develop robust assembly specifications with sound justification.Understand medical device/delivery system product design, functionality, storage, and handling requirements to… more
- Merck & Co. (Rahway, NJ)
- …in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide ... cell culture process development for biologics.Experience with high throughput microbioreactor systems , and advanced in situ analytics for process monitoring and… more
- Merck & Co. (North Wales, PA)
- …that include coordinating the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership ... supports statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the development… more
- Merck & Co. (North Wales, PA)
- …processes (SOPs) and software development life-cycle (SDLC) US and/or worldwide drug or vaccine regulatory application submission experience including the ... : This position supports statistical programming activities for late stage drug /vaccine clinical development projects. This may include leadership of one or… more
- Merck & Co. (Rahway, NJ)
- …Drug Development, Good Manufacturing Practices (GMP), Inventory Control System , Inventory Management, Management Process, Multiple Therapeutic Areas, Portfolio ... the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - Works directly...assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for… more
- Merck & Co. (Rahway, NJ)
- …and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings… more
- Merck & Co. (Rahway, NJ)
- …review with clinical partners and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for all study product needs ... (Bulk Drug Product and Clinical Finished Goods).- - Responsible for...non-pipeline activities. - Participate in Interactive Voice Response (IVR) System d evelopment and User Acceptance Testing (UAT) for… more
- Merck & Co. (Rahway, NJ)
- …cutting-edge capabilities in structure-based modeling, predictive science, and AI/ML to drive drug design and development globally, with a proven track record of ... teams on innovative science that has a wealth of opportunities to impact drug discovery and ultimately save and improve patient lives. Key responsibilities will… more
- Merck & Co. (Rahway, NJ)
- …devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers ... for global and site-specific projects related to combination products and drug delivery systems .Facilitate the professional development and performance of… 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 ... solving complex problems. Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or… more
- Merck & Co. (Rahway, NJ)
- …(FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply ... GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will leverage leadership skills in strategic… more
- Merck & Co. (Durham, NC)
- …and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key ... activities for pipeline vaccine programs.- This is position will support vaccine drug substance site readiness and technology transfer focusing on either upstream,… more
- Merck & Co. (North Wales, PA)
- …deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator-meeting planning, communication plans, preparation of ... Outlook, etc.)Education/Experience: Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience/ Master's… more
- Merck & Co. (Rahway, NJ)
- …Our Team as an Associate Principal Scientist/Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant impact in ... forefront of innovation in the-Manufacturing Division, specifically within the-Biologics Drug Substance Commercialization (BDSC) team. Our Downstream Purification-department is… more
- Genmab (NJ)
- …scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation ... and stratification plansPerform UAT of Randomization part of the IRT system as applicableEnsure procedures for blinding are in place as applicableSupport… more
- Merck & Co. (San Diego, CA)
- …and execute computational studies to elucidate molecular mechanisms of drug action (MoA), disease pathogenesis, and therapeutic response, leveraging multi-modal ... analysis strategies, and interpret results in the context of drug discovery and development in immunology.Effectively communicate complex computational findings… more
- Merck & Co. (North Wales, PA)
- …will support one or more assets, including but not limited to antibody drug conjugate assets for cancer treatment.To support the implementation of RWE capability ... with scientific leaders, patient organizations, academic medical centers, health systems , research organizations, database holders, and others.To prepare outcomes… more
- Insmed Incorporated (San Diego, CA)
- …process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... Development Team representative as an Analytical Lead for a drug program.Key Responsibilities:Responsibilities include developing and optimizing analytical methods… more
- Merck & Co. (North Wales, PA)
- …to meet the value evidence needs of payers, advisory committees health systems , and clinicians.The incumbent can generate these plans based on direct interactions ... evaluates health programs leveraging different parts of health care systems that can enhance value and use of products.Implements...need, patient reported outcomes (PRO) and the value of drug therapy as outlined in the OR planning process… more
