Jobs related to "Principal Scientist/Sr Scientist, Downstream MSAT - Expat in South Korea"
Principal Scientist/Sr Scientist, Downstream MSAT - Expat in South Korea
Laguna Source, LOS ANGELES california
This is an exciting foreign expatriate leadership opportunity responsible for overseeing Manufacturing Sciences & Technology (MS&T) related downstream purification manufacturing activities for large scale clinical and commercial recombinant protein manufacturing. This is a unique opportunity within an emerging Global Contract Manufacturing Organization (CMO) backed by a major multinational corporation. You will be charged with overseeing the following activities:
* Leading MSAT staff and projects relating to downstream purification manufacturing operations.
* Leading technology transfer processes and working cross functionally between Process Development and Manufacturing departments.
* Providing technical leadership and subject matter expertise relating to downstream related manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes.
* Working cross functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to lead downstream related process improvement, process validation, process change control, deviation investigation and process characterization activities.
* Serving as a technical/scientific Subject Matter Expert for downstream protein purification activities ranging from column chromatography, filtration (UF, DF, TFF), harvest and recovery.
* Managing laboratory experiments including scale down validation studies, process range studies, process robustness studies, and manufacturing troubleshooting activities.
* Defining, designing and developing critical process capability, critical process parameters, and process performance measurements through multivariate modeling and statistical measurements of Cp, Cpk, Pp, and Ppk.
* Training downstream staff on cGMP compliance and SOPs including writing/reviewing batch records, process validation documents, and sections of regulatory filings.
* Assisting in the build-out of BioPharma Manufacturing Data Systems, Process Intelligence, and Process Monitoring systems.
Desired Skills and Experiences:
* BS, MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Microbiology, Chemistry or related Life Sciences/Engineering field.
* 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
* Experience leading projects relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes.
* Strong experience working cross functionally within a BioPharma Manufacturing organization leading projects across Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments.
* Strong Scientific and Engineering technical experience performing downstream protein purification manufacturing activities involving column chromatography, filtration (UF, DF, TFF), harvest and recovery for the manufacturing of recombinant protein and monoclonal antibodies.
* Expertise involving QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma.