- University of Southern California (Los Angeles, CA)
- …cGMP Process Development SpecialistApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ cGMP ... internal/external users in the university's current Good Manufacturing Practices ( cGMP ) facility. The Process Development Specialist is responsible for developing… more
- University of Southern California (Los Angeles, CA)
- …cGMP Lab TechnicianApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/Senior- cGMP ... Supports daily manufacturing operations in current Good Manufacturing Practice ( cGMP ) facilities. Maintains materials, gowning, cleaning supplies, and consumable… 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 ... 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 Microbiological 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
- Kelly Services (San Antonio, TX)
- The Director of cGMP Manufacturing will be responsible for overseeing and leading the Manufacturing teams for both Mammalian and Microbial production in a cGMP ... schedules and timelines + Oversee proper staffing and training to support cGMP Manufacturing + Support Technology Transfer from Process Development or External… more
- University of Rochester (Rochester, NY)
- …I will be a member of the Microbiology and the Upstate Stem Cell cGMP Facility (USCGF) teams. The QC Associate will be responsible for upholding in-process and ... a timely manner to the QA Director of the cGMP Facility, therefore interacting and communicating with staff in...Microbiology and with staff in of the Stem Cell CGMP facility + Developing and implementing standard operating procedures… more
- Kelly Services (Louisville, CO)
- We are seeking multiple dedicated and capable ** cGMP Cleaning Technicians** to support a new manufacturing facility located in **Louisville, CO** . In this position, ... Monitoring Performance Qualification (EMPQ) and return to service activities + Performs cGMP cleaning in an aseptic clean-room environment (ISO5, ISO7, ISO8, ISO9) +… more
- System One (Exton, PA)
- …equivalent Experience: + Minimum of 2-4 yrs working experience in a cGMP Quality Control, analytical development, analytical transfer or validation department in a ... FDA-regulated industry. + Knowledge of principles, concepts, and practices in QC testing of protein biopharmaceuticals. + Hands-on experience with at least two techniques, such as HPLC, capillary electrophoresis, ELISA, or SDS-PAGE, used for analysis of… more
- Catalent Pharma Solutions (Harmans, MD)
- …Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for ... patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent Cell & Gene Therapy is a growing Contract Development and Manufacturing Organization (CDMO) with an internationally… more
- Honeywell (Buffalo, NY)
- Join Honeywell as a Sr Quality Assurance expert for the Buffalo cGMP manufacturing team. Ensure that appropriate cGMP Quality Systems are in place through review ... operating procedures impacting the safety, identity, strength, quality or purity of the cGMP products manufactured at the site. Conduct routine audits of 3rd party… 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
- Catalent Pharma Solutions (Harmans, MD)
- …healthier lives. 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
- Catalent Pharma Solutions (Harmans, MD)
- …healthier lives. 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
- ThermoFisher Scientific (St. Louis, MO)
- …solutions. **A day in the Life:** + Scan and archive batch records and other cGMP documents. + Organize, pack, ship, and receive batch records. + Perform sample and ... of logbooks, batch records, high risk forms and other cGMP documents with "right the first time" execution as...and assign effective dates to batch records and other cGMP documents. + Perform all document-related tasks such as… 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
- Lilly (Lebanon, IN)
- …and implement the necessary systems and business processes required to support cGMP operations, and build the site culture. This will require significant ... creativity and resilience as the site grows to a full-scale cGMP manufacturing through start up. **Key** **Responsibilities:** **Startup Phase:** + Support… more
- Cardinal Health (Memphis, TN)
- …day. Work hours may be subject to change. **Responsiblities** + Handles CGMP documentation review related to product release, facilities and equipment, material ... the site manufactures products to meet the requirements of 21 CFR 212 ( CGMP ). + Handles and ensures quality of documentation (control, retention, and archival) to… more
- Catalent Pharma Solutions (Harmans, MD)
- …- Manufacturing Technical Operations (MTO)** **Summary:** _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
- Catalent Pharma Solutions (Harmans, MD)
- …Process Development, Manufacturing, and Quality to ensure successful implementation of cGMP drug substance and drug product manufacturing processes. **The Role** + ... and documented according to approved change control procedures and in compliance with cGMP requirements. + Bridge the focus areas of R&D, Quality, EHS, Production,… more
- Catalent Pharma Solutions (Harmans, MD)
- **Manufacturing Associate II** **Summary:** _Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. ... 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
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