- Daiichi Sankyo, Inc. (Bernards, NJ)
- …determine relevant audit targets for GxP computerized systems for consistency.A seasoned quality leader with the ability to assess technology and computerized ... and implement a fit-for-purpose organization responsible for operational and technical oversight of QA across GxP (GCP/GVL/GCLP/GLP) systems. Lead … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …market research qualitative and quantitative marketing research projects as needed Act as leader and resource to build out technical and functional capabilities ... to deliver actionable managed markets insights is required Ability to lead without authority/reporting relationship required Analytical and/or technical … more
- Merck & Co. (Rahway, NJ)
- … Technical Depth and Breadth of Experience :--Recognized as a credible technical leader through demonstrated scientific excellence in at least one CMC ... Job DescriptionJob Description The Development and Commercialization Team (DCT) leader is-accountable for delivering a fully-integrated stage-appropriate CMC development… more
- Merck & Co. (Rahway, NJ)
- … Technical Depth and Breadth of Experience :- Recognized as a credible technical leader through demonstrated scientific excellence in at least one CMC ... to launch in line with enterprise priorities.-As the DCT leader , the Technical Product Leader ...interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality , and Supply Chain from early development through to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expertise in supporting RBQM activities.- Technical : Provides technical guidance in Quality by Design. Lead the team to define Critical to Quality ... as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team of Validation ... meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for...technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong… more
- Aequor (Thousand Oaks, CA)
- …label tool Monitor the compliance of autolabel tool updates (if applicable) Support and lead Quality Assurance of ICSR medical review (if applicable) Support and ... of ICSRs (narratives, coding, expectedness, causality, and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Act as MSRT product… more
- Merck & Co. (South San Francisco, CA)
- … Senior Scientist with experience in biochemical/biophysical assays and lead discovery support to join our Quantitative Biosciences (Pharmacology) department. The ... binding assays to characterize biomolecular interactions (equilibrium and kinetic) for lead discovery and optimizationSupport a wide range of biochemical and… more
- Novo Nordisk Inc. (Boulder, CO)
- …risk and cost to the overall operation. Relationships The Technical Team Lead , API Manufacturing reports to the Senior Manager, API Manufacturing. The ... with Chemical Development, Analytical Manufacturing, Engineering, Facilities, EH&S, Program Management and Quality Assurance. The Technical Team Lead , API… more
- Merck & Co. (Durham, NC)
- …management of post-approval physical product enhancements, process and method technical changes, robustness/ quality / productivity projectsManage product supply ... work experienceBreadth of experience in large molecule (biologics/ vaccines) operations, technology, quality , and/ or supply chainDemonstrated ability to lead a… more
- Merck & Co. (Durham, NC)
- …Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with External ... Demonstrated ability to deliver compliant supply and achieve highest quality , lowest cost, and shortest lead -time. Strategic...Ability to use deep knowledge and expertise in Manufacturing, Technical , and Quality Operations to drive results… more
- Merck & Co. (Rahway, NJ)
- …ensure that customer/stakeholder needs are the cornerstone of decisions and expectations- Lead technical investigations of medical device and combination product ... Job Description Summary, Focus and Purpose The Senior Engineer in Device Technology is a key...complex combination product kits, prefilled syringes, autoinjectors, and related scientific/ technical concepts and techniques are a must for this… more
- Aequor (Thousand Oaks, CA)
- …and senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network ... This "Specialist Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... are not limited to:--Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the individual to bring the latest knowledge in these fields, ensuring high quality and efficiency. This role will be responsible for recruiting and developing the ... resources for key programs. The role will also provide senior safety leadership and guidance on complex issues across...a meaningful impact on clinical development at the program level. Lead projects to enhance processes within CSPV, including the… more
- Merck & Co. (Rahway, NJ)
- …and engineers to design upstream, cell-culture processes while developing technical strategies related to upstream processing and recombinant expression of ... Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …support the day to day execution of validation activities, and related documentation/ technical writing overseen by support of more senior Validation Engineers. ... as needed Represent the Validation department on cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups) Assist in the training… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …potential? The Position This position has the responsibility of working with senior level Scientists and technicians to execute process development, scale-up, tech ... Flexibility in schedule is required for this role. Relationships Reports to: Lead Scientist (Supervisor) Essential Functions May perform one or more of the… more
- Merck & Co. (Rahway, NJ)
- …position available at our company's research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to ... define group strategy and to lead a team of scientists in solving complex analytical...collaboration is expected. Experience in leading small groups of technical personnel, leading projects, and defining group or departmental… more
- Raytheon (Miami, FL)
- …integrated circuits, and modules for defense applications.The AMSD Development IPT Lead is responsible for driving flawless technical , schedule, and ... exciting opportunity exists for a Sr. Principal Integrated Product Team (IPT) Lead to join our Advanced Microelectronics Solutions Department (AMSD) at Raytheon in… more
