- ThermoFisher Scientific (Cincinnati, OH)
- …closely work with internal and external project teams of analytical, quality , and project management representatives. Supporting process development and commercial ... processes for the following phases of product scale-up, registration, and validation . Creates processes and equipment design for clinical, scale up, and/or… more
- Fujifilm (Holly Springs, NC)
- …Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies, Holly Springs. The QC AD Chemistry ... suitability criteria. + Relevant experience in analytical method development and validation . + Demonstrated application and knowledge of ICH guidelines on analytical… more
- Corning Incorporated (Durham, NC)
- …with cross-functional teams including but not limited to Operations, Quality , Engineering, and Division Engineering. Primary responsibility will be support ... for sterilization* Supporting and executing activities related to development, validation , routine sterilization and requalification activities* Lead and work… more
- ThermoFisher Scientific (Grand Island, NY)
- …Designers- and partnering in a matrix with Engineering, Data Science, and Quality - and will incubate internal products and solutions, quantify ROI through measurable ... new initiatives. + Establish value-tracking metrics (cycle-time reduction, FTE hours saved, quality KPIs) and partner with Finance to baseline and report realized… more
- Kelly Services (Charles City, IA)
- …analytical support across multiple development projects, lead method development and validation efforts, and contribute to the successful scale-up of processes to ... interpret, and report analytical data to support process development and quality initiatives. + Participate in cross-functional teams to investigate and resolve… more
- GE HealthCare (Arlington Heights, IL)
- …& supply chain network in USCAN. This role ensures successful scale-up, validation , and commercial readiness of drug products while maintaining compliance with ... regulatory standards and company quality systems. The position requires strong technical understanding, cross-functional leadership, and expertise in managing… more
- ICF (Corvallis, OR)
- …team of 20 chemists and technicians providing laboratory support (sample analysis, quality assurance, and related support) data validation following NFG, ambient ... project assignments also include ambient air monitoring for priority pollutants, data validation for the Superfund and other programs, writing and reviewing … more
- Astrix Technology (Piscataway, NJ)
- …and other global regulatory standards. + Provide leadership and mentorship to quality team members; foster collaboration across manufacturing, validation , and ... **QMS Supervisor - Biologics Manufacturing** Quality Assurance Piscataway, New Jersey, US + Added...report writing. + Lead and manage PPQ and cleaning validation projects to support product and process integrity. +… more
- BeOne Medicines (Pennington, NJ)
- **General Description:** The Associate Director Quality Control (QC) will lead analytical strategy, method lifecycle management, and QC operations to support GMP ... cross-functional collaboration with Regulatory Affairs, Process Development, Manufacturing, and Quality teams, as well as external vendor management. This position… more
- J&J Family of Companies (Irvine, CA)
- …complex, multi‑discipline development programs from concept through design verification, validation , and transfer to manufacturing; manage technical tradeoffs and ... design control artifacts, risk management activities (eg, dFMEA, pFMEA) verification/ validation plans, and release decisions in accordance with regulatory and… more