- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …procedures. Provide expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP ... rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: We are looking for a manager to lead and manage the validation and testing activities for our platform products. This role ... platform team, in line with industry best practices and standards. Lead and manage a team of validation ...and standards. Lead and manage a team of validation and test engineers, providing guidance, coaching, and mentoring… 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 of validated systems. Coordinate technology transfer activities in support of… more
- Aequor (Libertyville, IL)
- The candidate must be able to work onsite at LibertyvilleJob Description: Lead a group of project managers to execute on their assigned program and associated child ... managers of problem projects to assist with identifying corrective actions. Co- lead setup of program management and governance structures in collaboration with… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal ... supervision, serving as the statistical lead in support of collaborations led by Translational Science...of human biomarker datasets to inform biomarker identification and validation , clinical development and business strategies. As the study… more
- Novo Nordisk Inc. (Durham, NC)
- …support is on site as needed during production activities Coordinate all validation /transfer activities involving MDev support Lead team in successful execution ... Management (Mdev LCM) in Emerging Technologies (ET) for the production site. Lead strategic activities ensuring new products can thrive without disrupting the… more
- Tris Pharma (Monmouth Junction, NJ)
- Sr Project Manager , Operations for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Lead + manage proj plans detailing milestones, bdgt, resources, ... timing + roles + responsibilities for prgms incl scale-up activities, process validation , post- validation changes + comm w/ FDA. Provide tech spt to… more
- Aequor (Austin, TX)
- …work on the planning and execution of capital projects, in a sourcing or procurement lead role or another role on the project team? (2) How many capital projects ... for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …eligible for selected candidate. Relationships Reports to: Sr. Operational Excellence Manager plus additional interfacing with Manager of Automation Engineering ... on a day-to-day basis, and act as the central resource for team communication Lead project scope and deliverables definition in concert with project champion and key… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …transfer traceability from Primary Standards to Laboratory Working StandardsSupport validation and production engineers in development of metrological specifications ... desire and ability to work in fast paced, growing and dynamic environmentAbility to lead a team and manage a calibration program across facilities; off shift and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Data Programming is a member of the Biostatistics and Data Management ... teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesManage external vendors… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Are you ready to realize your potential? The Position This position will lead a team of API Optimization Specialists, Manufacturing Area Specialists, and Project ... assistance eligible for selected candidate. Relationships Reports to: Sr. Manager Operational Excellence. Number of subordinates with direct/indirect referral: 6… more
- BioAgilytix (Boston, MA)
- In this role, you will perform validation studies through the analysis of biological samples. Our clients trust us to deliver excellence in data and bioanalysis, and ... objectives. Playing a pivotal role in our project lifecycle, you'll conduct validation studies on a spectrum of biological samples, ranging from biologics and… more
- Eisai, Inc (Nutley, NJ)
- …Architects and IT Operations. Partner with ITQA, Business Owner and IT Project Manager for defining a master validation strategy where applicable. Partner with ... experience in Pharma in job offered or as Product Manager /Global Delivery Lead . Also requires 2 years...application / system changes in accordance with computer system validation , 21 CFR Part 11 and GxP policies. Send… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead ... Possess signature authority for deviation closure Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action Reports… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the operation of the area Support evaluation, specification, installation, and validation of new manufacturing equipment as needed Maintains validated systems and ... re-validates existing systems in accordance validation procedures Incorporates value improvement programs and new processes from Product Support, Engineering, EH&S,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Supervisor of IT Operations Direct Reports: None Essential Functions IT Infrastructure Manager , covering GxP and non-GXP systems: Drive and maintain IT Operations ... IT Operations advocate, coordinating daily activities with the IT Manager (IT Infrastructure Owner) and team members Assists the...work package owner on IT Infrastructure related projects and lead internal and external team working as part of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to… more
