- Merck & Co. (Rahway, NJ)
- …in one of the above disciplines plus 5 years related experienceExperience with the development drug - device combination product or a medical device ... Development (DD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination ...position will be responsible for leading and implementing medical device and combination product design… more
- Merck & Co. (Rahway, NJ)
- …candidates that will include ensuring screening and development of robust drug product composition, scalable process, primary packaging, compatibility ... and supporting regulatory filings. Have deep fundamental knowledge around large molecule drug product development and have management responsibilities for a… more
- Merck & Co. (Rahway, NJ)
- …background.Experience with design of IV and SC drug products including drug - device combination products for biologicsExperience with process design ... scale, step across boundaries and implement novel innovations during drug product development to enable best science...tools, and requirements for all dosage forms (liquid, lyo, drug - device combinations)Review and approval of data and… more
- Aequor (Parsippany, NJ)
- …enviornment. - Prior Medicaid Claim processing experience with a Pharmaceutical and/or med Device company , state and/or state agency or as Medicaid consultant or ... equivalent work experience - Minimum 2&plus years pharmaceutical/ product focused healthcare experience; Medicaid Claim processing function; manipulation of large… more
- Aequor (Thousand Oaks, CA)
- …and in accordance with current regulations and guidelines within the medical device , combination product and bio-pharmaceutical industries. This person ... Academic experience should not be included in the YOE . Nice to have: Combination product experience. This team works with pre filled syringes 20% and 80% auto… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …lab equipment, and quality and regulatory requirements important to pharmaceutical and combination drug manufacturing labs.Help with plant audit ready status ... and quality and regulatory requirements important to pharmaceutical and medical device manufacturing labs.Able to write detailed investigation summary memos that… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- Description: Drug Device Combination Product Manager is a position within the Global Quality Management department.This position is a Corporate Quality ... dynamic, high paced and highly interdisciplinary environment to support Drug Device Combination Products. The...resourceful for troubleshooting and problem solving that pertain to Combination Product and Medical Devices. + Establish… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager, Drug Device Combination Product Development Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage ... Position Summary: We are seeking a highly skilled and experienced Sr. Manager, Drug Device Combination Product Development to lead the device… more
- Merck (Rahway, NJ)
- …one of the above disciplines plus 5 years related experience + Experience with the development drug - device combination product or a medical device ... Development (DD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination ...position will be responsible for leading and implementing medical device and combination product design… more
- Medtronic (Los Angeles, CA)
- …leading and providing technical design quality support for the new drug / device combination product development programs. The individual will act as a ... product portfolio. **A Day in the Life** + Leading large and complex drug / device combination product development programs per the FDA design controls… more
- Gilead Sciences, Inc. (Foster City, CA)
- …internal stakeholders and contract manufacturers to address and resolve complex technical related drug device combination product , process and quality ... the Commercial stage, including Design Transfer + Create/revise/execute SOPs to support combination product quality governance in the commercial stage. +… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …scientific principles and regulatory requirements relevant to global drug and drug - device combination product development, registration, and ... perform signal management process activities for assigned products, including combination products ( drug and device )...risk management, both written and verbal. + Utilizes technical combination product and device knowledge,… more
- Sanofi Group (Cambridge, MA)
- …common goals. The group provides GQ operational support for medical devices and Drug - Device combination product quality spanning development, ... thought was possible. Ready to get started? **Our Team:** The Global Quality Medical Device (GQMD) group's mission is to safeguard the quality of our products by… more
- Amgen (Thousand Oaks, CA)
- …complex, multi-disciplinary and multi-functional product development efforts + Experience in drug / device combination product design and development + ... Develop a verification testing strategy to include differentiation between platform and combination product testing to ensure minimum duplication and maximum… more
- PCI Pharma Services (Philadelphia, PA)
- …management + Six Sigma Green Belt or Black Belt certification preferred. + Drug - device combination product assembly and/or pharmaceutical background ... of PCI. Job Description **Position Title: Automation Engineer (Advanced Drug Delivery Devices)** **Reports** **to:** **Engineering Director/Manager** **FLSA Status:… more
- Sanofi Group (Cambridge, MA)
- …engaging with FDA, EMA, notified bodies spanning medical device , drug - device combination products, medicinal product , SaMD, and IVD with strong ... HF/UE best practices across Sanofi's portfolio of products including medical devices, drug delivery combination products, medicinal product , small molecules,… more
- AbbVie (North Chicago, IL)
- …primarily with a Software Engineering or Electrical Engineering background to join our Device Engineering team in Combination Product Development, R&D. This ... individual will contribute to the development of exciting new drug / device combination products for various...in operations as programs transition to commercial development. Within Combination Product Development, the Product … more
- Medtronic (Minneapolis, MN)
- … product portfolio includes new technologies and next-generation products in the combination , drug / device , product space. Responsibilities may include ... process development and validation, focusing on quality systems and combination product compliance (FDA 21 CFR Parts...to Have** + Medical device , pharma, or drug - device combination products preferred. +… more
- Wells Fargo (Charlotte, NC)
- We are seeking a Lead Digital Product Manager as part of Strategy, Digital & Innovation. This lead will be responsible for managing the overall strategy of the ... Device Trust Capability as part of an Authentication capability....capability for the 6 quarter roadmap. Works daily with Product Owners and stakeholders within the fraud, model governance,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …oversight and contribution to product development / design control for Drug - Device Combination Products. + Collaborate with cross-functional team in ... studies, audit and inspection readiness/support, training, ICSR excellence, and Medical Device / Combination Product safety. Gilead Sciences is seeking a… more
