- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Systems Lead role is an exempt level position with...sterile GMP environment. This role will serve as the business process owner for the Corrective and Preventive Actions… more
- Eisai, Inc (Indianapolis, IN)
- …you. The Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and manage a team of sales professionals. The ABL ... Sales Representatives on critical selling skills, clinical expertise and business acumen. Responsibilities: Develop and implement sales strategies and tactics… more
- Novo Nordisk Inc. (Langhorne, PA)
- …part of the team, you will have frontline exposure to our portfolio vision, business strategies, and critical market insights that drive our business forward. ... manage, train, develop staff, and prepare regional budget and business plans. This is an entry level district ...home office personnel. Essential Functions Adhere to the Prescription Drug Marketing Act of 1987 and all related Novo… more
- Merck & Co. (Rahway, NJ)
- …Drug Development, Good Manufacturing Practices (GMP), Inventory Control System , Inventory Management, Management Process, Multiple Therapeutic Areas, Portfolio ... between clinical development teams and the operational/executional arms within the business .-- - - The Program Clinical Supplies Project Manager (Program CSPM)… 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. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest,… more
- Merck & Co. (Rahway, NJ)
- …between clinical development teams and the operational/executional arms within the business .-- - - Working independently, the Protocol Clinical Supplies Project ... and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for..., visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).- - Responsible for… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on ... pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations of… 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 ... Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical...Supply management or Analytical Research is critical for understanding business opportunities, outcomes and execution. A passion for the… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of 7 years of relevant experience is required. Demonstrated experience translating business needs to system requirements. Cell/Gene Therapy cGMP manufacturing ... will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at… 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. (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. (North Wales, PA)
- …statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the development ... clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.Experience leading large and/or complex statistical… more
- Merck & Co. (Durham, NC)
- …role will contribute to the performance and results of a E2E drug substance/product department and provide technical guidance. Off-shift and weekend coverage will ... be required based on business unit needs during start up and operations, and...support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are… 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
