- 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...in the development of critical process parameters and provide technical leadership for deviation investigations Analyze data … more
- BioAgilytix (Boston, MA)
- …LaboratoryPrepare worksheets with minimal supervisionPrepare plate mapsServe as lead analyst on sample analysis projectsTroubleshoot assaysCompile/process data ... data , and reports (documentation according to GxP guidelines)Essential Responsibilities: Data Review & DocumentationPerform Quality Control (QC) technical and… more
- Aequor (Seattle, WA)
- …Technical Operations team and site MS&T cell therapy to compile and ready data for regulatory filings and to support validation activities. This position ... and Compliance Business Analyst is closely partnered with the Technical Product Team Lead and Stewards to...data verification processes to ensure accuracy and integrity. Lead quality system document review and routing. Follow up… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring ... (EDC & Non-EDC), industry standards (CDISC / SDTM), and technical skillsfor integrating and importing external data .../ any problems related to data transfers, data structure deviations or validation issues.Complies with… more
- Eisai, Inc (Nutley, NJ)
- …including budget. Works with key stakeholders to measure and prioritize technical debt remediation.Collaborate with CIO Office to align strategy, initiatives and ... as a service (IaaS), platform as a service (PaaS), SOA, APIs, open data , microservices, event-driven IT and predictive analytics and its applicability to the pharma… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a strong knowledge of AI/ML applications and best practices as well as strong technical skills in working with (clinical) data . The position holder will require ... business understanding and translation of business needs to AI/ML tasks, over data understanding and preparation, to modeling, validation and dissemination-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …implements new technologies, as needed and supports Supply Chain Management with technical issues post first CPV.Responsibilities- Lead and coordinate the ... The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing… more
- Lundbeck (Bothell, WA)
- …manufacturing organizations (CMOs) Collaborate with QC to ensure successful method validation at contract labs/CMOs; support investigations and lead ... data analysis packages Excellent communication (written and verbal), technical and organizational skills Critical thinking, troubleshooting and attention to… more
- Merck & Co. (Durham, NC)
- …and implementation of troubleshooting activities and change control. Initiate and lead collaboration within the Operations, Quality and Technical organizations ... you are responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety,… more
- Merck & Co. (Rahway, NJ)
- …in medical device and combination product design verification, the candidate will lead the strategy and execution of design verification activities from concept to ... dynamic and diverse team of experts, the candidate will spearhead the technical and scientific feasibility evaluation of the combination product and its components.… 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
- Eisai, Inc (Nutley, NJ)
- …to understand and evaluate the implications of clinical trials and real-world data ; demonstrate the value of interventions beyond efficacy, and assess benefits, ... In addition, the incumbent will ensure quality is maintained in all aspects of technical work as well as manage performance and ensure adequate training and support… more
- Merck & Co. (Rahway, NJ)
- …individual to work in a fast-paced job that provides both technical and project management responsibility. The Specialist - Manufacturing Automation position ... will report to the Director, Engineering, Automation Lead position and will be a member of the...ensure that the computer system operation and computer system validation is completed and maintained, and that the field… more
- Merck & Co. (North Wales, PA)
- …Activities will include developing, documenting, and maintenance of technical business solutions, reviewing and approving medical device/combination product ... documentation to support regulatory filings and audits of data , policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global ... Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for… more
- Merck & Co. (South San Francisco, CA)
- …probes in target identification and validation , hit-to- lead , and lead optimization programsProvide scientific mentoring and technical training of team ... novel medicines by applying innovative synthetic chemistry, analytical techniques, and data analysis to design and synthesize drug candidates and intermediates. In… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …other manufacturing systems. This position provides Tier 2 and 3 support, technical recommendations and direction, and coordinate technical projects, related to ... on LAN and WAN) Design, Support, troubleshoot, and maintain network communications ( data and voice) across facility Design, Administer and maintain Active Directory,… more
- Catalent (San Diego, CA)
- …and externally through oral and written updates and formal reports as necessary. Lead discussions with clients on technical topics relating to their project. ... Supervisor will not need to attend most client meetings.Exercise technical discretion and critical thinking in the design, execution and interpretation of… more
- Insmed Incorporated (Bridgewater, NJ)
- …in Design Control Process for medical device products and combination products. Lead the quality assessment for product lifecycle changes, efficiency projects, and ... Quality Assurance department.Support Statistical Trending of Manufacturing and Analytical Data .Additional duties as assigned QualificationsBS degree in Chemistry, Engineering,… more
- Fannie Mae (Washington, DC)
- …management strategies, and drive actionable insights. You will also act as team lead while conducting theoretical and empirical research with public and proprietary ... data in all areas of the mortgage finance business....coach and mentor team members.THE IMPACT YOU WILL MAKEThe Lead Quantitative Modeler role will offer you the flexibility… more
