- Merck & Co. (Rahway, NJ)
- …robust equipment and processes for clinical and commercial manufacture of drug- device combination products.Understanding of parenteral delivery device ... Job DescriptionAs a Senior Scientist in Device Design and Process Development group,...equipment design, conduct line trials including FAT and report project progress, risks, and mitigations to the team.Author process… more
- Merck & Co. (Rahway, NJ)
- …experience of managing device or combination product development programs and leading cross-disciplinary project teams.Has broad knowledge of ... and launches.Principal ResponsibilitiesLead and set direction for the device development strategy for multiple drug- device combination product … 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 and/or ... the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions, processes and device / packaging that enable… more
- Insight Global (Rahway, NJ)
- Job Description Insight Global is seeking a Combination Device Development Project Manager to join a pharmaceutical client's Device Product & Process ... DPPD Team manages the development of the device constituent of our company's pipeline of combination...reports/dashboards/risk register that summarize key progress and issues on development programs across different device project… more
- Merck (Rahway, NJ)
- …Leadership experience of managing device or combination product development programs and leading cross-disciplinary project teams. + Has broad knowledge ... Lead and set direction for the device development strategy for multiple drug- device combination...and engineering execution against the established requirements. + Represent Device Development and the project -specific… more
- Merck (Rahway, NJ)
- …develop robust equipment and processes for clinical and commercial manufacture of drug- device combination products. + Understanding of parenteral delivery ... **Job Description** As a Senior Scientist in Device Design and Process Development group,...equipment design, conduct line trials including FAT and report project progress, risks, and mitigations to the team. +… more
- Pfizer (Parsippany, NJ)
- …for device lifecycle management of on-market medical devices and combination products + Develop change management technical impact assessments, design and ... the activities of individuals and teams with focus on project /program issues + Liaison between GTEL Device ...0+ years of experience. + Prior experience in Medical Device or Combination Products Design Controls, Production,… more
- Merck (Rahway, NJ)
- …external stakeholders such as packaging and manufacturing sites, device development and technology, analytical, regulatory and project leaders. The ... with internal stakeholders, including commercialization, quality, analytical, regulatory, manufacturing, Device Development and Technology, Technical Product Leaders,… more
- Merck (Rahway, NJ)
- …background. + Experience with design of IV and SC drug products including drug- device combination products for biologics + Experience with process design and/or ... the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions, processes and device / packaging that enable… more
- Merck (Rahway, NJ)
- …Pharmaceutical new product development **Preferred Experience and Skills:** + Medical Device and Combination Product Packaging development experience + ... primary and secondary packaging components + Demonstrated understanding of Medical Device and Combination Product regulations + Demonstrated understanding of… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …cross- functional alignment for other medium and/or high complexity products (including combination , Software as a Medical Device , and standalone medical ... the Senior Manager, Global Labeling Devices. You will be responsible for the development , maintenance, and implementation of Instruction for Use (IFU) documents and … more
- New Jersey Institute of Technology (Newark, NJ)
- …especially microfabrication. - Experience in cleanroom operations and business development . - Well-developed project management and organizational skills ... Title: Associate Director of Operations and Business Development Department: York Center for Envir Engr and...oversee the technical aspects of MIC and business and project management aspects of both the centers. Working closely… more
- Merck (Rahway, NJ)
- …experience in packaging of pharmaceutical and/or medical device / combination products including design development and testing, process engineering, ... the human health portfolio covering both biologics and vaccines and including Medical Device and Combination Products (MDCPs). In addition, the candidate will… more
- Merck (Rahway, NJ)
- …Experience and Skills:** + Knowledgeable of design control, medical device , combination products, pharmaceutical packaging and related scientific/technical ... of resolving scientific/technical packaging issues. + Significant experience with medical device or combination product transfer, operations support, and… more
- Sanofi Group (Morristown, NJ)
- …with a focus on product development , registration, and market entry. + **Drug- Device Combination Products** - Experience with drug- device combination ... where you will be responsible for leading the switch development program to approval of an assigned Rx-OTC Switch...Management** - Oversee budget and timelines in collaboration with project management to deliver switch milestones on time and… more
- Sanofi Group (Morristown, NJ)
- …and consumer studies relevant to switch products is highly desirable. + **Drug- Device Combination Expertise** : Familiarity with approval processes for drug- ... where you will be responsible for leading the switch development program to approval of an assigned Rx-OTC Switch...device combination products (eg, diagnostics, software as a medical … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …of 8 years regulatory and/or related experience. + Expert knowledge of device development , registration and maintenance regulations with experience in ... regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project (s) of responsibility. **EDUCATION,… more
- Terumo Medical Corporation (Somerset, NJ)
- …medical device companies and actively secures business through effective development of account strategies and use of professional sales presentations + Educates ... part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations… more
- IQVIA (Bridgewater, NJ)
- …and ensuring appropriate recruitment strategies are in place. + Contribute to the development of the project risk mitigation plan. Manage clinical risks through ... by providing feedback to clinical team line managers on performance relative to project tasks to support professional development . + Adopt corporate initiatives… more
- Merck (Rahway, NJ)
- …transportation technologies for pharmaceutical products including parenteral and/or medical device and combination products. + Strong understanding of ... the real-world experience and enable translation into standard work development for distribution related characterization across packaging platforms to ensure… more
