- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Summary: -The Director, Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization. ... support global and site-specific projects, facilitate technology transfer, and drive product robustness for sustained launch in alignment with the company's business… more
- Merck & Co. (Rahway, NJ)
- …Medical Device Manufacturing, Medical Devices, Method Validation, Operational Acceptance Testing (OAT), Product Development, Prototyping, Social Collaboration, ... and process development using semi-automated and automated equipment, conduct functional testing , assist in clinical batch manufacture as an equipment subject matter… more
- Tris Pharma (Monmouth Junction, NJ)
- …(ST) samples and executes physical characterization studies to facilitate product understanding. The incumbent also performs other lab assignments including, ... instruments, carries out and documents laboratory work to support product development and analytical method development and supports laboratory investigations… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Device Product & Process Development (DPPD) Team within our Device Development & Technology (DD&T) organization designs, develops, and ... manages the development and commercialization of the device constituent and combination product of our company's pipeline of combination products across a variety of… more
- Merck & Co. (Rahway, NJ)
- …a strong understanding of statistical principles, expertise in medical devices and combination product processes, and analytical testing for devices, as well as ... responsible for leading a team focused on developing and implementing product control strategies, statistical analysis, and advanced statistical methods for medical… more
- Repligen (San Diego, CA)
- …support will include system qualifications for Installation and Operation (IQOQ), product testing , system maintenance and customer training. Delivering training ... Perform Sample testing on customer samples and in support of product development and sales.Train Customers on the theory and operation of the SoloVPE,… more
- Merck & Co. (Rahway, NJ)
- …development related meetings (i .e., Clinical Trial Team s ) and product development related meetings . The incumbent must have demonstrated understanding of ... E2E product development process & connectivity between functions supporting pipeline...Voice Response (IVR) System d evelopment and User Acceptance Testing (UAT) for assigned studies . - Mentors new… more
- Merck & Co. (South San Francisco, CA)
- …technology advancements, and regulatory requirements for diagnostic assays.Drive diagnostic product innovation and improvement through both in-house R&D efforts and ... plusOther Qualifications:10+ years of industry experience in clinical biomarker testing and CDx development.Deep understanding of scientific concepts, clinical… more
- Merck & Co. (Rahway, NJ)
- …project digital programs.Responsibilities include:Planning and allocating resources for cross- product delivery and coordinating with investment Manager to ensure ... current and future landscapes for CMC overlaid with digital capabilities.Work closely with Product Line Leads to ensure the best user experience and the use of… more
- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including ... federal and local laws Performs validation of analytical methods and release/stability testing for raw materials, IP, FP and ST samples of pilot/pivotal/submission… more
- Merck & Co. (Upper Gwynedd, PA)
- …include, but are not limited to:Regulatory Responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of ... all regulatory milestones through product development including assessment of the probability of regulatory success together with risk mitigation measures.-Lead… more
- Merck & Co. (Rahway, NJ)
- …change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and ... Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing… more
- Insmed Incorporated (San Diego, CA)
- …Development Operations function to build out the process development support testing function within analytical development. Will develop systems and processes to ... facilitate rapid, high throughput testing . As the Sending Unit, will facilitate transfer of...method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage research through commercial launch. Involves… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and process validations in accordance with validation procedures Perform in-process product testing in accordance with standard procedures Support manufacturing ... a global supply of our hemophilia and growth hormone product lines, as well as our next generation of...adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. The Front End… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and collaboration across relevant cross functional groups to ensure robust production, testing and release of product to patients.Serve as the delegate ... multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will range from employee… more
- Merck & Co. (Durham, NC)
- …and clerical functions necessary for proper accountability and traceability of product . - Maintains, inventories, and transports all required processing equipment, ... and decontamination according to approved procedures. - Completes in-process testing and inspections supporting the vaccine manufacturing, validation, and… more
- Merck & Co. (North Wales, PA)
- …programming point of contact and knowledge holder through the entire product lifecycle. Primary Activities :Effective analysis and report programming development and ... standardsDemonstrated success in the assurance of deliverable quality and process compliance .Strategic thinking - ability to turn strategy into tactical activities;… more
- Merck & Co. (Rahway, NJ)
- …clinical site. The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie ... health), and balancing needs of patients & ensuring stable supply of product .Primary activities include, but are not limited to:-Participates on the Clinical Trial… more
- Shimadzu Scientific Instruments (Houston, TX)
- …personnel on proper instrument operation and maintenance. Accurately document all repairs, product failures, and improvements to ensure compliance with company ... is one of the largest suppliers of analytical instrumentation, physical testing , and environmental monitoring systems in the world. Ground-breaking scientific… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.Key Responsibilities Provides ... Right First Time culture of quality, permanent inspection readiness compliance mindset and passionately drives continuous improvementProvides technical expertise in… more
