This is an exciting foreign expatriate leadership opportunity responsible for leading primarily Upstream Manufacturing Sciences & Technology (MSAT) operations for large scale commercial manufacturing for the generation of monoclonal antibodies, Antibody Drug Conjugates, Bispecific Antibodies and Fusion Proteins. This is a once-in-a-lifetime Global Expat leadership opportunity within the World’s Largest biologics CMO expanding to 720,000L total mammalian cell culture manufacturing capacity. You will be charged with overseeing the following activities:
* Providing technical and organizational leadership for primarily upstream related manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes.
* Serving as a technical/scientific Subject Matter Expert primarily for upstream cell culture/fermentation activities ranging from vial thaw, inoculum, media development, media optimization, cell line development and stainless steel bioreactor operations.
* Serving as a technical/scientific Subject Matter Expert secondarily for downstream protein purification activities ranging from column chromatography, filtration (UF, DF, TFF), harvest and recovery.
* 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.
* Managing organizational laboratory experiments including scale down validation studies, process range studies, process robustness studies, and manufacturing troubleshooting activities.
* Managing organizational technology transfer processes including the authoring of tech transfer documentation including PCS, GAP reports, Process FMEA, Campaign Summaries and Process Validation documents.
* Interfacing and engaging with global BioPharma clients and partners throughout Business Development, Product Lifecycle and Technology Transfer projects.
* Driving programs and initiatives driving plant operational excellence, Six Sigma and lean manufacturing.
* Ensuring all plant safety policies and procedures are met in compliance with internal and external regulatory standards.
Preferred Candidate Background and Expertise:
* BS, MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field.
* 10-15+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
* Strong team leadership overseeing Upstream and Downstream MSAT organizations and teams.
* Strong Scientific and Engineering technical experience performing upstream mammalian cell culture manufacturing activities involving vial thaw, inoculum, media development, media optimization, cell line development and stainless steel bioreactor operations.
* 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.
* Experience leading projects relating to process validation, manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes within cGMP, FDA and EMA compliance.
* Expertise involving Plant Operational Excellence, QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, Lean Manufacturing and Six Sigma methodologies.
*** Please Note - This is a full-time Expat Opportunity Based in South Korea. You must be open to living and working in South Korea. A company paid apartment and International School tuition is provided. ***
* Competitive base salary, target bonus, retirement allowance and excellent medical benefits.
* Company paid luxury apartment in Songdo.
* International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools.
* Company paid airfares to visit the US (or country of origin).
* 3 weeks of vacation time.
* Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way up to Sr. Director and VP levels
* Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund, Celltrion, Merck and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University.
* Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport.
You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/
