- 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
- 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)
- …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
- 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
- Genmab (NJ)
- …families and employees.Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly ... scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation… 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)
- …for management of third party manufactures of our Company's products across drug substance, drug product and packaging operations.- The organization helps ... compliance with the Supply AgreementPartners with the ExM Company Production System experts and other functionalities supporting ExM (eg technical, quality,… more
- Lundbeck (Bothell, WA)
- …of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our ... chemicals, and consumables including ordering and receiving using Lundbeck procurement system Process biohazardous waste for pick-up Media and buffer preparation… 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. (Rahway, NJ)
- …Development & Technology (DD&T) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... MINIMUM REQUIREMENTS: BA/BS in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering,- or other types of engineering plus 10 years of… 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. (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. (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
- Aequor (Thousand Oaks, CA)
- 100% Onsite supporting ATO Copy of AMAGJP00014054 Standard business hours You've worked hard to become the professional you are today and are now ready to take the ... time. In this critical role for the Thousand Oaks Drug Product (DP) facility, - also known as ATO...Introduction Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI… 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 ... as a program lead on a PDT as required by the business .ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team… more
- Merck & Co. (Rahway, NJ)
- …advice to stakeholders creating optimal development, commercialization, and drug /delivery device supply strategies-Building our leadership and functional capability ... regulatory activities with cross- product or cross-functional impact, including drug device/combination products and software as medical device platforms.- Reviews… more
