Job Description: The GMP Lead is responsible for giving direction, motivation, and guidance to a team of cleaners...
; lead and influence others effectively. This position is responsible for…. The Engineering Technician II supports... (Good Documentation Practices), ISO (International Organization for Standardization) and GMP (Good Manufacturing Practice...
and communicates risks to leadership in an expedient manner. May serve as technical lead for execution of clinical sample testing... in the lab. Your Key Responsibilities: Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following...
: Expedite test sample shipments to sponsors and third-party laboratories. Deviation Management: Lead investigations... in alignment with GMP requirements. Method Transfers: Support analytical method transfers, including product-specific test methods...
but mighty team at OCN that consists of the site’s Chief of Staff and Strategy, Communications Lead, Organizational Change... Management Lead, and Program Manager of Strategy and Operations. Within this team, we enable key Network and Site initiatives...
-launch). In addition, this role is also expected to lead projects for cell culture process technology development, platform...-specifics, and novel modalities. Lead and/or support entire lifecycle of pivotal activities including process risk assessment...
experience. Strong knowledge in mass spectrometry, experimental design, and assay development. Dermonstrated ability to lead... processing. Knowledge of ICH guidelines and GMP is a plus. Expertise in mass spectrometry analysis software (Protein Metrics...
as needed. Track and trend critical process parameters and in process checks as the lead for ongoing process verification (OPV...) and identify CAPAs to address any trends. Identify, assess, and own technical changes through GMP change control processes...