- Tris Pharma (Monmouth Junction, NJ)
- …and carries out method validation activities, including interim method validation , to meet project timelines. Supports laboratory investigations and ... honest communications to help support individual and team success. Our Method Validation Department located in our Monmouth Junction, NJ headquarters has an… more
- Merck & Co. (Durham, NC)
- …they relate to laboratory testing start-up, regulatory requirements for method transfer/ validation project timelines and budgetingBuild knowledge of the company, ... and vendors to identify, to ensure successful execution of method transfer or method validation activities.Apply project management concepts and techniques as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with project stakeholders.- Provide oversight to assure that all validation work performed for Daiichi Sankyo by various contractors meets Global DX ... 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: Director (M3), Analytical External Capabilities, Validation & Compliance (ECVC).The selected candidate will work in the Analytical ... Experience & Skills:- Outstanding communication, critical thinking, and leadership skills. Project management experience including resource management, budget forecasting, and… more
- BioAgilytix (Durham, NC)
- …patients who need them.Essential ResponsibilitiesServe as lead scientist on assay development, validation , and sample analysis project Follow GMP guidelines for ... assays and sample analysisIndependently write plans and reports for validation and sample analysisResponsible for prompt identification, submission, notification,… more
- Merck & Co. (Rahway, NJ)
- …as a subject matter expert in mass spectrometry-based assay development and validation , collaborating with project teams, biomarker leaders, clinical operations ... will play a critical role in the development and validation of Mass Spectrometry based assays that are deployed...should have a strong interest in lab-based assay development, validation , and sample analysis. In addition, the candidate should… more
- Merck & Co. (South San Francisco, CA)
- …through various stages of drug discovery, including - target identification and validation , building a project team, developing research operating plans (ROPs), ... of cardiometabolic disease.-Key Responsibilities:Lead projects through target identification and validation , hit finding, lead identification and optimization, and preclinical… more
- Aequor (Bothell, WA)
- …and quality control organizations. This position requires a passion for IT, validation , and compliance. Project management and business analyst skillsets within ... projects and technical work assignments as a point of contact for project stakeholders.Lead or provide supporting activities within the quality management system… more
- Aequor (Thousand Oaks, CA)
- Project Integrator * Candidate will be working primarily remotely, with possibility to work onsite * Bachelors Degree in Engineering * 5&plus years of experience ... coordination, status reporting and stability of Combination Product Operations (CPO) project activities. Manages one or more cross-functional projects of medium to… more
- BioAgilytix (Durham, NC)
- The LIMS Project Manager at BioAgilytix will oversee the comprehensive implementation, customization, and optimization of the LabVantage Laboratory Information ... role requires close collaboration with both BioAgilytix's internal teams and the external project team, ensuring that all project workstreams are aligned, and… more
- Aequor (Louisville, KY)
- …vendors. Minimum Education - Bachelor's with 4 years of experience C&Q Project Manager?Responsible for managing the Commissioning and Qualification (C&Q) strategy or ... main workstreams for a project . The C&Q PM will be responsible for supporting...equipment/system design, specification and supporting the construction, startup, and validation of equipment. Act as a liaison between Engineering,… more
- Merck & Co. (Durham, NC)
- …technology capabilities/solutions with quality policies and objectives. Ensure the initial project tailoring is appropriate for the complexity and risk to ... of work. Provide the independent quality approval of key qualification/ validation documentation such as policies, procedures, acceptance criteria, plans, protocols,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …knowledge for the development/refinement and implementation of the GEP program and validation standards based on risk-based practices as prescribed in ASTM E2500. ... best practices Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems Lead the development… more
- BioAgilytix (San Diego, CA)
- …to the patients who need them.Essential ResponsibilitiesServe as Bioanalytical Project Manager (BPM)/Principal Investigator (PI) on a projectMay prepare and ... submit deviationsManage project timelines/schedulingManage budget and revenue for projectsCommunicate with clientTrain analysts/junior scientistsDevelop assay… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …also responsible for the delivery of systems, configuration and associated validation activities of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment ... by a deep understanding of the current operating modelDrive key project deliverables, including requirements definition, process design, solution design, test… more
- Aequor (Thousand Oaks, CA)
- …pharma/biotech experience * Biotech/ pharma experience required) * Analytical method validation and transfer experience Ideal candidate with a bachelor's degree in ... the global method implementation team (GMIT) responsible for method transfer and method validation to Quality Control for pivotal and late stage programs. The role… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …large scale complex projects focused on business/process performance improvement Create project charter, scope and management plan Identify necessary resources for ... successful project execution Responsible for monitoring and managing the ...a matrix management environment with specific experience in development, validation , start-up and continuous improvement of manufacturing facilities, processes… more
- BioAgilytix (Durham, NC)
- …Part 11.o Partner with BioAgilytix's Quality and Regulatory teams to support validation , documentation, and audit readiness for all system and integration processes. ... and address business needs in system and integration tasks. Project Leadershipo Lead or collaborate in LabVantage-related projects, including implementations,… more
- Tris Pharma (Monmouth Junction, NJ)
- …in analytical method development, physical characterization, formulation support, interim validation , pilot release testing and stability testing activities for all ... (SOPs)/current Good Manufacturing Practices (cGMPs)/policies are met and develops project strategies, approaches, timelines and goals for analytical milestones and… more
- Merck & Co. (Rahway, NJ)
- …and safety evaluation.The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently ... lifecycle.Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
