- Merck & Co. (San Francisco, CA)
- Job Description Position Description: Associate Director, DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... organization, the Digital Project Manager will streamline the execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the organization. This ... position ensures that all global systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best… more
- Merck & Co. (Rahway, NJ)
- …medical device engineering, particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination ... of product design and development, manufacturing process development, qualification, validation , and design control and risk management techniques to positively… more
- Merck & Co. (Rahway, NJ)
- …GMP procedures and documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities, and computer systems.- Prepare and ... approve qualification protocols and summary reports.- Execute qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation … more
- BioAgilytix (Durham, NC)
- …team is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical ... studies-including project scope definition, proposal preparation, timelines, scheduling, budget, and...someone with a strong background in method development, GxP-compliant validation , and targeted and untargeted analysis using chromatography and… more
- Twist BioScience (South San Francisco, CA)
- …requirements gathering, system design, coding standards, development, rigorous testing, validation , deployment, and post-go-live support for new and existing ... capabilities to support operational decision-making and quality reviews.Compliance & Validation : Ensure our custom MES solutions comply with GxP regulations… more
- Repligen (Rancho Dominguez, CA)
- …a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at our Rancho ... manufacturing systems. Lead projects in equipment design, tech transfer, process validation , and facility upgrades. Conceives, plans, and executes projects or… more
- Eisai, Inc (Exton, PA)
- …(as required). The Associate Director sets strategic directions and project priorities, providing scientific leadership and oversight and managing individual ... suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting… more
- BioAgilytix (San Diego, CA)
- …and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in ... client engagement, project delivery, and cross-functional collaboration.Essential ResponsibilitiesLead team(s) developing and validating bioanalytical assays for… more
- Merck & Co. (Rahway, NJ)
- …thinking to advance ADC, Complex Biologics and Small molecule portfolio. Project management skillsAttention to technical detailBuilds collaborations across internal ... writing / review of regulatory filings including INDs and NDAs.Exposure to project / engineering work process and deliverables (eg equipment fabrication, FAT, SAT,… more
- Eisai, Inc (Nutley, NJ)
- …of Eisai Clinical Computing Environment Support study migration, program validation , technical documentationManage J-Review set up, J-Review user access management, ... of relevant programming and application development experience, 5 or more years project management & people management experience Experienced in working in Medidata… more
- Aequor (Tampa, FL)
- Carries out the practical work in the laboratory including method development, method validation and trouble shooting. Takes over responsibility for the QC part of ... QC chemist to provide the method technology transfer and project preparation work, make sure the project ...and regulatory audits as area SME. Develops and executes validation protocols for test methods and equipment qualification. Author… more
- Merck & Co. (North Wales, PA)
- …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
- Aequor (Thousand Oaks, CA)
- …at ATO B20. The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that ATO B20 with a ... Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with other functions including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT. This individual will ... other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities according to the Software Development Lifecycle (eg commissioning test… more
- Aequor (East Syracuse, NY)
- …fast-paced, interactive, and entrepreneurial environment. Position is a team and project -based position that may require occasional shift work, weekends, and ... for supporting analytical method lifecycle activities including method development, qualification, validation , and technical transfer of methods for the testing of… more
- Merck & Co. (North Wales, PA)
- …evaluation. - The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with ... - Primary Activities : Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and… more
- Novo Nordisk Inc. (Durham, NC)
- …practices, to include increasing awareness of data management standards & validation to create improvements in methods, techniques, approaches etc. for optimization ... from wide variety of data sources Support manufacturing, business, and project departments with process understanding, analyses, and systematic problem solving… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …issues Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems, including documentation ... representative for contractor services including design, fabrication, installation, and validation Point person for process improvement activities, including performing… more
- Aequor (Devers, TX)
- …support. Leadership and Guidance: Provide leadership and guidance to the Project Team and cross-functional stakeholders to ensure accurate execution of SAP ... Leads to provide SAP training. Program Sessions: Attend all Project program sessions as the Procurement Lead. Ensure all...approve all necessary UAT test scripts. DCT Verification and Validation : Approve Site Procurement Data Load Files in support… more
