- Novo Nordisk Inc. (Boulder, CO)
- …both worlds to develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug ... a laboratory setting as needed. This position will lead a team of Drug Product Managers and manage their own projects. Relationships This position reports to the… more
- Merck & Co. (Rahway, NJ)
- …and combination products. This position also supports other critical activities such as drug product and combination product final assembly processes ... execution in support of critical activities such as stability studies, drug product filling process validation, combination product final assembly process… more
- Merck & Co. (Rahway, NJ)
- …for technology transfer, problem-solving and working collaboratively with receiving sites, drug product partners,and Technical Product Leaders, regulatory ... combination products, with a focus on autoinjectors, prefilled syringes, and other drug deliverysystems. The Associate Director will collaborate with a team of… more
- Merck & Co. (Rahway, NJ)
- …group in late stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and ... Job DescriptionJob Summary: The Director, Combination Product Commercialization is a key leadership role within...with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team… more
- BeOne Medicines (Pennington, NJ)
- …This role in the Manufacturing Science and Technology (MST) department supports BeOne's Drug Product Manufacturing site in New Jersey (Hopewell). This role will ... lead the site drug product MST function to support technology transfer, validation, continued process verification, investigations, change management and… more
- Parexel (West Point, PA)
- We are looking to fill a **Scientist 3 - Analytical Chemist - Drug Product ** position working as **a full-time employee of Parexel FSP on long-term assignment** ... testing (ie- assay/impurity testing) and data processing/interpretation on sterile pharmaceutical drug products in supply + Ability to work independently and as… more
- Merck & Co. (Rahway, NJ)
- …for small and large-molecule drug substance (upstream and downstream) and drug product manufacturing unit operations. Your expertise in computational fluid ... and engineers to create end-to-end predictive models that support drug substance and drug product manufacturing operations. Examples of problems on… more
- Merck & Co. (Rahway, NJ)
- …and accountable for establishing the timelines for bulk manufacturing-needs and release of drug product across assigned program(s). Works directly in the SAP ... visible forecast for all products used within the assigned program(s) (ie Bulk Drug Product ). Oversees all bulk drug supply management and ensures proper… more
- Merck & Co. (Rahway, NJ)
- …subject matter expert technical support for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The ... for new and commercial human health products including active pharmaceutical ingredients, drug substance, drug product , finished goods including combination… more
- Merck & Co. (Rahway, NJ)
- …for subject matter expert technical support for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.- The ... for new and commercial human health products including active pharmaceutical ingredients, drug substance, drug product , finished goods including combination… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …performing a wide range of activities to support the Manufacturing and release of CAR-T drug product for human use. This position is responsible for quality and ... turnaround times are adhered to during review and disposition of the Drug Product deadlines.Perform duties/tasks under minimal direction/supervision according to… more
- Merck & Co. (Rahway, NJ)
- …(eg temperature monitors).- To provide SME guidance in support of small molecule drug substance and drug product container closure systems including ... mission. The successful candidate will possess deep packaging and/or combination product technical expertise, a strong track record in problem-solving, strategic… more
- Merck & Co. (Millsboro, DE)
- …requirements 9CFR - Required Skills: Analytical Thinking, Batch Record Review, Drug Product Manufacturing, Pharmaceutical Manufacturing, Product Release, ... Job DescriptionThe Senior Quality Specialist ensures product /process quality system adherence and batch record review, completes quality checks and SAP transactions… more
- Aequor (Thousand Oaks, CA)
- …7-10 years of experience including a strong technical pharma/bio tech background. Nice to have: drug substance or drug product , and device expertise Nice to ... Commercial space working with the Operations Leader and the Product Delivery Team. The Sr. PM will manage cross-functional...to meet deliverables with their teams. Partnering with key Product Delivery Team stakeholders, the Sr PM will need… more
- Insmed Incorporated (NJ)
- …of relevant FDA, EU, ICH, PMDA guidelines, initiatives and regulations governing CMC drug product development.Ability to deal with issues of critical importance, ... to read and collate scientific and medical literature.Experience in drug substance and drug product ...and medical literature.Experience in drug substance and drug product development.Strong communication skills with demonstrated… more
- Merck & Co. (Millsboro, DE)
- …Skills: Aseptic Manufacturing, Aseptic Processing, Biologics, Driving Continuous Improvement, Drug Product Development, Fill and Finish, Formulation ... transfer and scale-up of freeze-drying and fill-finish processes for vaccine and biologic drug products used in Animal Health. This role partners closely with Large… more
- Merck & Co. (Rahway, NJ)
- …in the SAP system to establish a consolidated, visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods). Responsible ... at clinical development related meetings (ie, Clinical Trial Teams) and product -development related meetings. The incumbent must have demonstrated understanding of… more
- AUROBINDO (Durham, NC)
- …phase clinical supplies preferred - Experience with in-vitro bioequivalence and/or drug product characterization preferred.Ability to provide direction to the ... broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages. Aurobindo markets over 80% of the top 100 most… more
- Insmed Incorporated (NJ)
- …instrumentation, technologies, and methodologies to support efficient and effective drug product process development.Manage external vendors and contractors ... as related to drug product manufacturing services and products.Maintain safety, regulatory, and compliance standards as they relate to the development of… more
- Merck & Co. (Rahway, NJ)
- …Data-Driven Decision Making, Deviation Investigations, Driving Continuous Improvement, Drug Product Development, Estimation and Planning, Fast-Paced ... relevant experience. Required Experience and Skills: Experience with small molecule drug substance and/or biologics process development and scale-up, moving from… more
