- Novo Nordisk Inc. (Boulder, CO)
- …best of both worlds to develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical ... drug product manufacturing including process characterization activities to support commercialization...own projects. Relationships This position reports to the Executive Director , Manufacturing. Essential Functions Lead, manage, and advise all… more
- Novo Nordisk Inc. (Boulder, CO)
- …leadership, managing business integration & site strategy to support manufacturing of clinical product through testing and quality programs to ensure product ... us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA involved functions and DS Global QA organization. Demonstrate engagement with GMP QA quality managements, Pharma Product QA teams and other QA functions as ... effective collaboration with DS affiliates to promote a culture of quality that drives performance and teamwork.Responsibilities:GMP Audit: Support the completion of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Programs.Collaborate with the Sr Director , Medical Affairs QA to conduct quality reviews of product profiles, ensuring thorough management review of all ... across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director… more
- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:We are seeking a highly experienced Senior Director , DSPV Medical Safety to help us expand what's possible for patients with ... serious diseases. Reporting to the Executive Director , DSPV, you'll be the medical expert for assigned...for assigned products and maintain current knowledge of assigned product portfolio and safety profiles. This individual will provide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Senior Director , Clinical Safety, will lead the development and implementation of integrated ... project/ product risk management strategies aimed at achieving the optimum...to strategically manage benefit-risk throughout the lifecycle of the drug . Specific responsibilities will vary depending on the stage… more
- Merck & Co. (Rahway, NJ)
- …with respect to device component manufacture and final assembly of biologic/ drug product with device constituent part.Lead/support the development, ... degree is preferred.Leadership experience with working knowledge of device, biologic/ drug product , and process development including regulatory submission… more
- Merck & Co. (Rahway, NJ)
- …management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product , Analytical Development, and ... Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development...Experience in one or more of the areas of Drug Substance development, Drug Product … more
- Formation Bio (New York, NY)
- …base in pharmaceutical sciences or engineering to drive successful drug product development and manufacturing operations.Responsibilities Technical Leadership: ... and long term program objectives. CRO and CDMO Management: Oversee and manage drug product vendors, for both development and manufacturing, ensuring high-… 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
- 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 ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...The successful candidate will possess deep packaging and/or combination product technical expertise, a strong track record in problem-solving,… 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 ... Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate ...and commercial human health products including active pharmaceutical ingredients, drug substance, drug product , finished… more
- Capital One (Washington, DC)
- …Portfolio Operations team, a critical part of this mission, supports roughly 700 product , technology, and design associates. As the Director of this team, ... Director , Technology (Portfolio Operations) The ideal candidate will...this role you will bring together key stakeholders across product , tech and lines of business together to drive… more
- Merck & Co. (Rahway, NJ)
- …Development, Communication, Communication Management, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Estimation and Planning, General ... Troubleshooting, Pharmaceutical Process Development, Process Control Automation, Process Optimization, Product Formulation, Project Management, Quality Control Management,… more
- Merck & Co. (Rahway, NJ)
- …clinic/marketAccelerated timelines for site, filing, and launch readinessImproved access to product and process dataStreamlined transfer of process and product ... workflows.- - Required Skills and Experience: Knowledge of manufacturing, testing, quality , and supply chain processes from late clinical development through… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …development, and performance of all engineering operations across Raritan Carvykti drug product manufacturing. This role ensures that the manufacturing ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , Engineering as part of the Technical Operations team based in… more
- Capital One (Norfolk, VA)
- Director , Distinguished Engineer ( Card Tech) As a Distinguished Engineer at Capital One, you will be a part of a community of technical experts working to define ... will work alongside our talented team of developers, machine learning experts, product managers and people leaders. Our Distinguished Engineers are leading experts… more
- Insmed Incorporated (NJ)
- …implementing global regulatory strategies and plans to enable efficient, competitive product development for assigned programs. This role will provide regulatory ... input to global cross-functional project teams throughout product development and submission activities. The GRL will serve as the global regulatory lead for… more
- Capital One (Richmond, VA)
- Director , Distinguished AI Engineer (Remote-Eligible) At Capital One, we are creating responsible and reliable AI systems, changing banking for good. For years, ... teams to deliver our industry leading capabilities with breakthrough product experiences and scalable, high-performance AI infrastructure. At Capital...You love to build systems, take pride in the quality of your work, and also share our passion… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2) applications. This role involves strategic leadership in clinical ... trials, clinical sciences, medical monitoring, target product profile (TPP) development, due diligence projects, and clinical-regulatory compliance.… more
