- Insmed Incorporated (Bridgewater, NJ)
- …in Design Control Process for medical device products and combination products. Lead the quality assessment for product lifecycle changes, efficiency ... York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr . Director for the compound, on regular basis ... primary accountability for operational study level time, cost and quality deliverables. Lead the development of the...or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.Ensure adherence… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before ... and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Technician, MaintenanceThe Senior Maintenance Technician is responsible for providing equipment troubleshooting and ... embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.The Lab Senior… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before ... immune disorders. Summary Oversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical trials;… more
- Catalent (Harman, WV)
- Senior Director, Supply Chain Position Summary: The Senior Director, Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Lundbeck (Bothell, WA)
- …Lundbeck Biopharmaceuticals is seeking a highly motivated and experienced individual to lead the Potency Assay group supporting the development of novel therapeutic ... role will interact with Lundbeck Seattle Upstream, Downstream, Formulation, and Quality Control groups so strong interpersonal skills will be beneficial. ESSENTIAL… more
- Merck & Co. (Rahway, NJ)
- …medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- ... products and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead … more
- Eisai, Inc (NJ)
- …you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, ... the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Merck & Co. (South San Francisco, CA)
- …motivated, and curious scientist for our Modeling and Informatics group. As a Senior Scientist (R3), you will be part of a multidisciplinary team, collaborating with ... chemistry, and deep learning to problems of biological interestExperience with lead identification and lead optimization of diverse therapeutic modalitiesAbility… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The HCP Experience Lead will play a critical role in ensuring the successful execution of brand/therapy ... and monitors adherence to administrative policies and procedures. The HCP experience lead has a team reporting to them potentially inclusive of hcp experience… more
- Novo Nordisk Inc. (Boulder, CO)
- …Boston 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 ... you ready to make a difference? The Position The Senior IT Engineer I - Labs will be responsible...in Boulder, CO and reports to the Lab IT lead in Lexington, MA. Additional internal stakeholders include IT… more
- Merck & Co. (Rahway, NJ)
- …and aspiration of our Company's digital (Chemistry, Manufacturing, and Controls) CMC program to set the foundation for a digital continuum from development to ... manufacturing for our products and processes. The digital CMC program is a multi-year investment, and will need to...the full technology stack across of Operations, Supply and Quality .- The resultant standard architecture must fulfill the needs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo, ... In this key role, the candidate will have to lead a complex, global team in charge of a...complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle… more
- Novo Nordisk Inc. (Boulder, CO)
- …timely fashion and in a manner which meets their expectations Acts in role of lead Quality Assurance for NN Boulder Change Control process, including review and ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr . Director for the compound, on regular basis ... bodies.Triage, resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.Ensure adherence to internal procedures… more
- Merck & Co. (Rahway, NJ)
- …and compose complex presentations and both intra- and inter-divisional communications.-Optimize program execution inclusive of Scope, Quality , Timeline and ... interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with...bring their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, company policies and procedures and-with quality standards internally and externally.Under the oversight of the CRD(Clinical ... interns-delegated to the Clinical Operations team based on the Internship program , while-properly managing situations of low or non-performance.The role will work… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible for overseeing multiple program -level CS Asset ... as well as external investigators is expectedThe CS Group Lead will also ensure the writing of high- quality...life cycle is optimized across multiple programsThe CS group lead will also contribute to the program … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally ... sterilized products. Lead the validation team in the establishment and maintenance...commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy… more
