- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and ... robust assembly specifications with sound justification.Understand medical device/delivery system product design , functionality, storage, and handling requirements… more
- Merck & Co. (Rahway, NJ)
- … strategies. This individual will be expected to apply his/her knowledge of product development and design control principles to positively support ... Council Directive 93/42/EEC, etc.Proven track record of applying analytical skills in product design , development , and evaluationSelf-motivated and work… more
- Merck & Co. (Rahway, NJ)
- …regulatory compliance expectations across all phases of product development to commercialization.Demonstrated leadership skills and organization design (ie ... Leadership, Pharmaceutical Development , Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development , Regulatory CMC, Statistical Design … more
- Merck & Co. (Rahway, NJ)
- …current Good Manufacturing Practices (cGMPs) ideally during pharmaceutical drug substance / drug product development and production, eg in a pilot and/or factory ... technical responsibility and leadership of internal and external work.The Senior Scientist, Engineering position leverages scientific/technical experience to develop… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily ... including critical program needs related to new products undergoing process development , new products undergoing scale-up, launch and transfer to the supply… more
- Merck & Co. (North Wales, PA)
- …a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter ... state-of-the art scientific methodologies and tools to enable the discovery, development , regulatory approval, manufacturing, and marketing of medical drugs and… more
- Repligen (Rancho Dominguez, CA)
- OverviewWe are seeking a highly motivated and experienced Senior Engineer to lead multi- product project execution, manufacturing support, and technology transfer ... TFF and other bioprocessing manufacturing systems. Lead projects in equipment design , tech transfer, process validation, and facility upgrades. Conceives, plans, and… more
- Formation Bio (New York, NY)
- …to lead all Chemistry, Manufacturing, and Controls (CMC) activities related to biologic product development at Formation Bio. This is a strategic and ... by Design (QbD) principles and their application in CMC development . Demonstrated success working with third-party partners and CDMOs, including defining scope… more
- Merck & Co. (Rahway, NJ)
- … strategies. This individual will be expected to apply their knowledge of product design and development , manufacturing process development , ... development .Required Experience and Skills:Broad knowledge of medical device and combination product development , design controls and risk management,… more
- Merck & Co. (North Wales, PA)
- …projects, including pipeline candidates and licensed products. The Section Head manages Product Development Team (PDT) leaders and clinical directors responsible ... for the design and medical monitoring of clinical studies.Supervises ...assets within the pediatric section of the Vaccine Clinical Development TA.May serve as a senior therapeutic… more
- Merck & Co. (North Wales, PA)
- …outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams, Regional Product ... programs.- Brings strong payer and HTA/reimbursement focus into the Product Development Team(s).Develops the integrated evidence strategy including HTA/OR… more
- Formation Bio (New York, NY)
- …BioBank, FinnGen, AllofUs) Background working at the intersection of data science, product development , and business strategy in pharma/biotech Formation Bio is ... teams. These predictive models will seamlessly integrate with our Clinical Development processes, directly impacting trial design and execution. This position… more
- Merck & Co. (Rahway, NJ)
- …regulatory standards (eg, FDA, cGMP), maintain optimal environmental conditions for product quality, and support continuous operations. The ideal candidate will have ... strong technical expertise in HVAC design , maintenance, and validation within a highly regulated environment,...the site BAS and HVAC control systems. Manage the development and oversight of site operations through data analytics.Establish… more
- Twist BioScience (South San Francisco, CA)
- …assay development teams to provide bioinformatics insights for product troubleshooting and optimization.Collaborate with other Senior Bioinformatics ... Senior / Staff Bioinformatics Production Scientist (Hybrid in South...combine genomics expertise with strong production engineering skills to design and implement robust, scalable computational pipelines for large-scale… more
- Merck & Co. (Durham, NC)
- …compounds is a plus. New Product Introductions - Knowledge of Pharmaceutical product development and commercialization. Awareness of MDCP development and ... Manufacturing Operations will also assist in commercialization activities for New Product Introductions that require complex devices and other novel technologies.… more
- Merck & Co. (Rahway, NJ)
- …Risk Assessments.Must Have At Least 2 Years of Experience in The Following: Product Development and Commercialization with Focus on Pilot PlantsDetailed ... and change requests. Define intent in Front-End Loading, Peer input during design , oversight during operation and development /implementation of Process Safety… more
- Twist BioScience (South San Francisco, CA)
- …working in both startup and big-company environments is a plus.Familiarity with both product development and manufacturing activities is a plus.PMP or similar ... culture and team, be a key driver in Twist's successful New Product Introduction (NPI) and strategic business transformation initiatives from concept to launch.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development , and performance ... 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
- Repligen (Waltham, MA)
- …and corrective action plans prior to implementation when required. Review and approve New Product Development Design History Files for the site. Assists with ... the site quality assurance team which includes all day-to-day activities for product manufacture, test and release including deviation support, root cause analysis,… more
- Insmed Incorporated (San Diego, CA)
- …experience with droplet digital PCR (ddPCR). This individual will be responsible for design and development of ddPCR assays, quantitating DNA and mRNA both ... on experience, the Sr Research Associate will expand molecular and product specific assay development working with the analytical development team. Beyond… more
