- 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 ... a highly motivated individual to join the USC/CHLA Cell Therapy program and cGMP Facility. The successful candidate will work on the process development and… 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
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Current Good Manufacturing Practice ( cGMP ) Specialist position is responsible for adherence to Standard Operating Procedures (SOPs) and ... cGMP regulations pertaining to the manufacture of therapeutics and...assist them with transitioning their research processes to compliant cGMP SOPs. + Participates in multi-functional project teams, as… more
- University of Southern California (Los Angeles, CA)
- cGMP Senior Quality Control (QC) SpecialistApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/Senior- cGMP ... it is. The Senior QC Specialist at the USC/CHLA cGMP Facility will lead advanced quality control activities to...GDPs). Extensitve experience with standard operating procedures in a cGMP laboratory setting. Demonstrated ability to work as an… 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
- Boehringer Ingelheim (Fremont, CA)
- …recognizing and reporting process and equipment anomalies. + Documents work according to cGMP and cGDP. + Adheres to established regulations and follows cGMP ... + Four (4) or more years of experience in cGMP regulated industry. + Ability to concentrate on detail...instructions and document work in a written format applying cGMP standards. + Ability to work as part of… more
- Boehringer Ingelheim (Fremont, CA)
- …recognizing and reporting process and equipment anomalies. + Documents work according to cGMP and cGDP. + Adheres to established regulations and follows cGMP ... + One (1) or more years of experience in cGMP regulated industry. + Ability to concentrate on detail...instructions and document work in a written format applying cGMP standards. + Ability to work as part of… more
- Sanofi Group (Swiftwater, PA)
- …volume and needs + Completes tasks and corresponding documentation as required by cGMP to ensure document completion. + Works to prepare assigned areas for the ... to need. + Follows proper documentation as required by cGMP . + Has a thorough working knowledge of cGMP 's and works to help others understand. + Ensures all… more
- Catalent Pharma Solutions (Harmans, MD)
- …on, 2 days off, 3 days on rotation.)** Catalent's FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus ... the completeness and accuracy of manufacturing documentation by approved procedures. + cGMP batch review and close-out with Quality Assurance group. + Ensure staff… more
- Amgen (Holly Springs, NC)
- …the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at Amgen North Carolina. Responsible for ... Qualifications:** + High school diploma / GED and 10 years of cGMP laboratory, analytical instrument validation, and/or Process Engineer experience OR + Associate's… more
- Stanford University (Stanford, CA)
- …therapy manufacturing consistent with principles of current Good Manufacturing Practice ( cGMP ) and aligned with the clinical trial investigational phase for treating ... CAR T cell therapies. + Train on biomanufacturing and cGMP procedures. + Plan and perform components of process...trials. + Perform upstream and downstream components of assigned cGMP projects. + Identify, document and report operating excursions… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …broad multifaceted capacity and are responsible for understanding the full CGMP framework established at the site including product development approach, ... through commissioning. + Developing, revising and approving all manner of CGMP framework including protocols, SOP-s, BMR-s, risk assessments and summary reports.… 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. + ... specific SME developing, revising and approving all manner of CGMP framework including protocols, SOP-s, BMR-s, risk assessments and...good manual dexterity. - Must possess basic knowledge of CGMP -s. - Must be able to transcribe detailed data… more
- Eurofins (Columbia, MO)
- …applications. The successful candidate will perform method establishment and validations under cGMP guidelines on a diverse set of methods including, HPLC, GC, Amino ... biology and 5 years of experience working in a cGMP laboratory OR Master's degree and 3 years of...degree and 3 years of experience working in a cGMP laboratory OR PhD and 1+ years of experience… more
- Amgen (Holly Springs, NC)
- …the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at Amgen North Carolina. Responsible for ... Qualifications:** + High school diploma / GED and 8 years of cGMP laboratory, analytical instrument validation, and/or Process Engineer experience OR + Associate's… more
- Boehringer Ingelheim (Fremont, CA)
- …kits, Updating controlled SOP binders, support projects. + Documents work according to cGMP and cGDP. + Adheres to established regulations and follows cGMP ... preferred. + 2 or more years of experience in cGMP regulated industry. + Ability to concentrate on detail...instructions and document work in a written format applying cGMP standards. + Ability to work as part of… more
- PCI Pharma Services (Bedford, NH)
- …including chemicals, biologics and packaging / labeling materials in accordance with cGMP and procedural requirements + Request, assemble, and distribute QC testing ... tracking and chain of custody records in accordance with cGMP and procedural requirements **.** **Write and revise ...cGMP and procedural requirements **.** **Write and revise cGMP documents and Material Control Procedures (MCP) to meet… more
- Catalent Pharma Solutions (Hanover, MD)
- …MD facility. Catalent's Harmans/BWI, MD facility is a FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus features two ... 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)
- …inspections. + Work with Quality management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products. + Compliance + Ensure ... other QA teams and other functions in completion of site actions. + Provide cGMP guidance to other functions such as Manufacturing, Facilities and QC, Warehouse and… more
- Stanford University (Stanford, CA)
- …is to be consistent with principles of current Good Manufacturing Practice ( cGMP ) and aligned with the clinical trial investigational phase for treating patients ... perform, and supervise manufacturing of clinical materials according to cGMP standards in Biosafety Level 2 (BSL2), cGMP... cGMP standards in Biosafety Level 2 (BSL2), cGMP -level work conditions and adherence to corresponding requirements. +… more
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