- Aldevron (Miami, FL)
- …in:Experience in technical writing and supporting investigations in a cGMP compliant Quality Control Laboratory setting.Experience working with external testing ... laboratories and CMO development and manufacturing partners.Familiarity with lipid nanoparticles (LNPs) and associated analytical test methods.#LI-GC1#LI-OnsiteJoin our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science… more
- Cytiva (Miami, FL)
- …molecular biology, biochemistry, or related discipline is a plus.Pilot scale and/or cGMP experience is a plus.Deep understanding and experience with all downstream ... unit operations.The salary range for this role is $110,000 - $120,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.This job is also… more
- Cytiva (Miami, FL)
- …assurance processes.Deep understanding of ISO 14644, sterility processes, and cGMP (current Good Manufacturing Practices) in medical device product ... manufacturing.Experience with Water, Endotoxin, Bioburden, Conductivity, and TOC testing.Travel, Motor Vehicle Record & Physical/Environment Requirements:Ability to travel - 10% travel within the Boroughs area.Must have a valid driver's license with an… more
- University of Southern California (Los Angeles, CA)
- cGMP Manufacturing Specialized Laboratory TechnicianApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ cGMP ... what it is. USC's Keck School of Medicine, current Good Manufacturing Practices ( cGMP ) facility is seeking a dynamic individual to work on the process development… more
- University of Southern California (Los Angeles, CA)
- cGMP Process Development (PD) SpecialistApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ cGMP ... what it is. USC's Keck School of Medicine, current Good Manufacturing Practices ( cGMP ) facility is seeking a dynamic individual to work on the process development… more
- University of Southern California (Los Angeles, CA)
- cGMP Associate Director, Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ cGMP ... staff that make the university what it is. USC's Keck School of Medicine, cGMP Department is seeking a dynamic individual to foster and enhance the translation and… more
- University of Southern California (Los Angeles, CA)
- cGMP Quality Control (QC) SpecialistApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ cGMP ... of internal/external users in the university's current Good Manufacturing Practices ( cGMP ) facility. The Quality Control (QC) Specialist is responsible for… more
- Honeywell (Baton Rouge, LA)
- The Quality Assurance (QA) Manager oversees, implements, and maintains cGMP compliant systems and activities. Incumbent is also responsible for evaluating internal ... controls and maintenance of cGMP documentation for compliance with quality and regulatory standards....with disabilities to perform the essential functions. + Ensures cGMP analytical activities, such as analytical methods, test results… more
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Sr. Current Good Manufacturing Practices ( cGMP ) Specialist is responsible for adherence to Standard Operating Procedures (SOPs) and cGMP ... highly regulated radiopharmaceutical drug manufacturing facility in compliance with FDA cGMP guidance. **PEOPLE ESSENTIAL FUNCTIONS** + Provides work direction of… more
- University of Southern California (Los Angeles, CA)
- cGMP Quality Control Lab TechnicianApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ cGMP ... Medicine is seeking a specialized microbiological technician to support the cGMP facility and associated laboratories. The technician will execute microbiological… more
- University of Southern California (Los Angeles, CA)
- cGMP Quality Control (QC) Specialized Laboratory TechnicianApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ ... therapy of internal/external users in the university's current Good Manufacturing Practices ( cGMP ) facility. The cGMP Quality Control (QC) Specialized Lab… more
- Sumitomo Pharma (Morrisville, NC)
- …and experienced individual for the position of Manufacturing Associate II, cGMP Manufacturing role. The Manufacturing Associate will support facility start-up ... A minimum of 2+ years of experience in a cGMP manufacturing environment along with a degree in science...related discipline OR a minimum of 3+ years of cGMP manufacturing experience with a high school diploma is… more
- Sumitomo Pharma (Morrisville, NC)
- …highly motivated, and experienced individual for the Manufacturing Manager, cGMP Manufacturing role. The Manufacturing Manager will ensure production readiness ... with isolators is preferred. + Experience at an FDA approved or late-stage cGMP manufacturing site + Experience in production batch record review, investigation of… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …activities and will be hands-on solving issues during technology transfer and cGMP start-up. The MSAT team establishes best practices for technical support of ... cGMP drug product manufacturing operations. The Engineer also provides...transfer, manufacturing document creation, etc. + Reviews and approves cGMP batch documentation (eg master batch records, component specifications,… more
- Actalent (Rockville, MD)
- …associate will provide hands-on technical support for all aspects of cGMP cell therapy manufacturing, including technology transfer, process validation, and process ... + Assist in planning, writing, and managing the execution of cGMP manufacturing protocols, batch records, SOPs/WIs, and plans. + Prepare manufacturing/campaign… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …by anything less than perfection. + Thinks creatively within the bounds of cGMP framework to overcome challenges and brings viable solutions to the table. + ... good manual dexterity. - Must possess basic knowledge of CGMP -s. - Must be able to transcribe detailed data...be able to transcribe detailed data accurately according to CGMP and SOP standards. - Must be able to… more
- Sanofi Group (Pearl River, NY)
- …(CCS). + **Expertise in regulations** : Your knowledge of US and EU cGMP regulations will be crucial, especially during audits where you'll represent the department. ... the strategic direction for quality and compliance processes related cGMP . + **Continuous improvement** : to develop and implement...: to develop and implement strategic direction for EU cGMP related quality and compliance processes as well as… more
- Catalent Pharma Solutions (Harmans, MD)
- …life-enhancing and life-saving treatments for patients annually. Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the ... and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The… more
- Fujifilm (College Station, TX)
- …procedures in accordance with US and international regulatory agencies, ICH, general cGMP , and international guidance. This role involves leading the data review ... of systematic reviews and data integrity, with skills and experience in cGMP data review requiring multi-departmental collaboration. **Company Overview** The work we… more
- Albireo Energy, LLC (Edison, NJ)
- …calibration to ensuring compliance with Novartis quality standards and applicable cGMP regulations. + Responsible for equipment maintenance, diagnostics and repair ... in a cGMP regulated environment. + Responsible for maintaining the calibration...resources and local system owners. + Ensure compliance to cGMP , regulatory regulations and Novartis global and local policy… more
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