- 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
- 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
- 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
- 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
- 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. (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
- 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
- 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. (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 (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
- 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
- Merck & Co. (Rahway, NJ)
- …and a track record of supporting global filingsExperience on a large capital project team, knowledgeable of the Sterile Standards and equipment design standards, and ... understanding of project / engineering work process and deliverables (eg, equipment...and deliverables (eg, equipment fabrication, FAT, SAT, qualification / validation )Current Employees apply HERE Current Contingent Workers apply HERE… 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
- Merck & Co. (Rahway, NJ)
- …communication to cross-functional stakeholders, including external suppliers.-Proactively resolve project obstacles and challenges and communicate device development ... and present ideas to senior leadershipExcellent communication, presentation, negotiation, project management, and organizational skillsWilling to travelAble to quickly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ongoing studies and compound level pooled clinical trial data of project (s). Act as statistical expert consultant within company for safety ... handling, lead the statistical support in safety signal detection, validation , characterization and reporting in collaboration with safety programming team,… 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
- 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 (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
