- Unknown (Columbus, OH)
- …background in oligonucleotide synthesis, and purification, and a deep understanding of cGMP , FDA, and EMA guidelines are essential. The role also involves authoring ... and reviewing regulatory filings, leading tech transfer activities, and managing a team to meet the demands of the advancing pipeline. Applicants for this role at the company should hold a minimum of a Bachelor's degree in a relevant field, with a Master's or… more
- Unknown (Somerville, MA)
- …should have a deep understanding of FDA and EMA regulations, experience with cGMP requirements, and a successful track record in contributing to IND, BLA, and ... MAA submissions for novel products. Hiring Manager Title Chief Legal Officer Travel Percent Less than 10% Functions Operations more
- Unknown (Redwood City, CA)
- …Quality Management System, overseeing all GxP activities, and ensuring compliance with cGMP , GDP, and local regulatory requirements. This role involves leading a ... team of quality professionals, proactively identifying and addressing quality issues, and providing QA oversight for product lifecycle activities. The VP, Head of Quality will also be accountable for the outcome of Health Authority inspections and must foster… more
- Unknown (Exton, PA)
- …A minimum of 10 years' experience in implementing cell culture systems in cGMP manufacturing environments, and at least 8 years in a Director-level or higher ... manufacturing operations role, is required. The ideal candidate will have a proven track record in manufacturing and supply chain success, hands-on experience with commercial cell culture systems, and expertise in technology transfer and scale-up of cell… more
- Unknown (Waltham, MA)
- …1001-5000 Specialties plasmid dna messenger rna (mrna) recombinant proteins crispr/cas9 cgmp gmp-source gene therapy cell therapy vaccine development and gene ... editing About the Role The Company is seeking a Vice President of Research and Development to join their mission-driven team. The successful candidate will be at the forefront of advancing science and unlocking human potential, with a focus on life sciences,… more
- University of Southern California (Los Angeles, CA)
- …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 ... and gene therapies and other biological products for internal/external users. The cGMP Process Development (PD) Specialized Lab Technician at the USC/CHLA cGMP… more
- University of Southern California (Los Angeles, CA)
- …what it is. USC's Keck School of Medicine, current Good Manufacturing Practices ( cGMP ) facility is seeking a qualified cGMP Vector Manufacturing Associate to ... all reagents in accordance with established protocols. In addition, the cGMP Vector Manufacturing Associate will be responsible for the calibration, troubleshooting,… more
- University of Southern California (Los Angeles, CA)
- …of internal/external users in the university's current Good Manufacturing Practices ( cGMP ) facility. The Quality Control (QC) Specialist is responsible for ... be responsible for ensuring consistency with current Good Manufacturing Practice ( cGMP ) principles. Job Accountabilities: + Supports cGMP manufacturing… more
- University of Southern California (Los Angeles, CA)
- …what it is. USC's Keck School of Medicine, current Good Manufacturing Practices ( cGMP ) facility is seeking a qualified cGMP Quality Control Associate to ... and regulatory compliance of cell and gene therapy products. In addition, the cGMP Quality Control Associate will be responsible for the calibration and maintenance… more
- University of Southern California (Los Angeles, CA)
- …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 ... biological products for internal/external users. The Associate Director of Process Development ( cGMP ) is responsible for all aspects of operations related to the… more
- University of Southern California (Los Angeles, CA)
- …to support essential operations within its current Good Manufacturing Practices ( cGMP ) facility. The successful candidate will be responsible for monitoring facility ... The Facilities Assistant will play a key role in ensuring that the cGMP facility remains fully operational and compliant with all applicable regulatory and safety… more
- Solstice Advanced Materials (Buffalo, NY)
- …value to our customers every day. As a Quality Assurance expert for a new cGMP manufacturing team. Ensure that appropriate cGMP Quality Systems are in place ... operating procedures impacting the safety, identity, strength, quality or purity of the cGMP products manufactured at the site. Conduct routine audits of 3 rd party… more
- Fujifilm (Research Triangle Park, NC)
- …activities while maintaining strict adherence to Current Good Manufacturing Practice ( CGMP ), quality and regulatory standards. Flexibility with working hours and ... right place for you. From our Bioprocess Innovation Center to our cGMP -compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether… 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
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …activities, and will be hands-on solving issues following technology transfer and cGMP start-up. The MSAT team establishes best practices for technical support of ... cGMP drug product manufacturing operations. The DP MSAT Engineer...transfer, manufacturing document creation, etc. + Reviews and approves cGMP batch documentation (eg master batch records, component specifications,… more
- Eurofins US Network (Columbia, MO)
- …department. The successful candidate will perform method establishment and validations under cGMP guidelines on a diverse set of methods including, ELISAs, and ... 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 minimum 1 year(s) of… more
- Cambrex High Point (Charles City, IA)
- …and subject-matter expertise for analytical data review activities within a cGMP Quality Control laboratory supporting API and intermediate manufacturing. This role ... effective CAPA implementation within TrackWise. + Maintain and manage cGMP -compliant laboratory documentation systems, including instrument logbooks, laboratory notebooks,… more
- Bristol Myers Squibb (Devens, MA)
- …ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP . The Manager, Shop Floor Quality Assurance, Cell Therapy is responsible ... accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP . Functional responsibilities include ensuring operational compliance with applicable… more
- Fujifilm (Research Triangle Park, NC)
- …activities while maintaining strict adherence to Current Good Manufacturing Practice ( CGMP ), quality and regulatory standards. Flexibility with working hours and ... right place for you. From our Bioprocess Innovation Center to our cGMP -compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether… more
- West Pharmaceutical Services (Exton, PA)
- …this role you will support the laboratory with data review generated to comply with cGMP and Data Integrity (DI). You will be responsible to ensure raw data and ... are reviewed on a timely manner and comply with cGMP , DI and West requirements. You will execute daily...individual and departmental goals as required. + Apply required cGMP regulations and follow all policies and procedures. +… more
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