Director/Principal Scientist, Analytical Methods Development - Expat In Korea

This is an exciting foreign expatriate opportunity responsible for overseeing analytical methods development and qualification activities for large scale clinical and commercial recombinant protein manufacturing activities. This is a unique opportunity within an emerging best in class Global Contract Development Manufacturing Organization (CDMO). You will be charged with overseeing the following activities:

* Leading analytical development activities for the characterization of biopharmaceutical products utilizing HPLC, LC-MS, Capillary Electrophoresis, Peptide Mapping, Mass Spectrometry, SDS-PAGE, ELISA, gel electrophoresis and modern glycoprotein & carbohydrate characterization techniques.

* Providing analytical methods development and qualification expertise involving process validation and the validation of analytical methods within cGMP compliance.

* Leading technology transfer processes and working cross functionally with Quality Control departments.

* Designing and conducting stability, impurity and degradation studies.

* Leading analytical related process characterization studies.

* Contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions.

* 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, MSAT, Regulatory, Quality Assurance and Quality Control departments.

Desired Skills & Experience

* BS, MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field.

* 8+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.

* Protein Analytical expertise developing methods for the characterization of large molecule proteins, recombinant proteins and monoclonal antibodies.

* Expertise working with HPLC, LC-MS, Capillary Electrophoresis, Peptide Mapping, Mass Spectrometry, SDS-PAGE, ELISA, gel electrophoresis and modern glycoprotein & carbohydrate characterization techniques.

* Experience contributing to CMC sections of regulatory filings including IND, NDA, and BLA submissions desired.

* Experience working on technology transfer and validation activities within cGMP compliance.

* Expertise involving QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma a plus.