- Lilly (Durham, NC)
- …in aseptic environment; 5 years of experience with equipment qualification and process validation ; and 3 years of experience managing cross-functional groups. ... logistics, and systems administrator engineering group supporting asset delivery, process development, commissioning, qualification, validation , start-up, and… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …level Positions) + Perform the Tracking System Deployment for Stability Samples/ Process Validation Samples etc. + Perform the Training Tracking Tool/Software ... procedures and systems for RM, PM, FD and in process testing in QC lab. Provide information, data for...transfer of analytical methods for new products. Execute cleaning validation of new products. + Assist in the monitoring… more
- Fujifilm (Holly Springs, NC)
- …Management * Prior drug substance or manufacturing experience, including process validation , transfer, commercialization, and manufacturing support and ... analysis, peptide mapping, and physical appearance * Ensures analytical testing of in- process , drug substance (DS), drug product (DP), and stability samples is… more
- Fujifilm (Holly Springs, NC)
- …Management * Prior drug substance or manufacturing experience, including process validation , transfer, commercialization, and manufacturing support and ... **What You'll Do** * Manages analytical method transfer and validation activities for cell- and plate-based Bioassays for the...protocols, and reports as part of the tech transfer process to onboard client programs * Liaises with Contract… more
- Lilly (Concord, NC)
- …+ Facility, Equipment, Systems Start-up + Equipment design, qualification, and process validation . + Manufacturing Execution Systems and electronic batch ... the project phase, the Operations Manager (OM) will support commissioning, qualification, and validation of the Device Assembly and Packaging (DAP) areas as well as… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …of QC staff + Perform the Tracking System Deployment for Stability Samples/ Process Validation Samples etc. + Perform the Training Tracking Tool/Software for ... procedures and systems for RM, PM, FD and in process testing in QC lab. Provide information, data for...transfer of analytical methods for new products. Execute cleaning validation of new products. + Assist in the monitoring… more
- Lilly (Concord, NC)
- …+ Facility, Equipment, Systems Start-up + Equipment design, qualification, and process validation . + Manufacturing Execution Systems and electronic batch ... the project phase, the Operations Associate (OA) will support commissioning, qualification, and validation of the Parenteral (PAR) areas as well as lead / assist in… more
- Sumitomo Pharma (Morrisville, NC)
- …are required as scheduled. **Job** **Duties** **and** **Responsibilities** + Participate in process validation activities for Sumitomo Pharma America, Inc. new ... processing steps and provides real-time feedback. + Redlines and reviews process Standard Operating Procedures (SOPs). + Develop a suitable level understanding… more
- Lilly (Concord, NC)
- …reviews + Facility, equipment, or system start up. + Qualification and process validation experience. + Manufacturing Execution Systems and electronic batch ... staffing, training, and leadership of the parenteral group during asset delivery, process development, operations readiness, start-up, and validation of the… more
- Cytel (Raleigh, NC)
- …statistical support for CMC-related studies, including formulation development, stability studies, process validation , and analytical method validation . + ... Collaborate with cross-functional teams, including analytical scientists, process engineers, and regulatory affairs, to develop and implement appropriate statistical… more