This is a stellar opportunity responsible for leading Deviation Investigations, Corrective Actions and Preventative Actions for the drug substance manufacturing of monoclonal antibody therapeutics and ADCs. This is a once-in-a-lifetime Global Expat leadership opportunity within the World?s Largest biologics CMO expanding to 784,000L total mammalian cell culture manufacturing capacity across 5 plants with commercial monoclonal antibody, Antibody Drug Conjugate and mRNA manufacturing capabilities. You will be charged with overseeing the following activities:
* Leading Deviation Investigations of manufacturing process events through the performance of holistic root cause analysis and product impact assessments for Drug Substance deviations.
* Establish robust CAPAs based on the result of deviation investigations and providing expertise to prevent the reoccurrence of deviations.
* Supporting FDA & EMA regulatory inspections and audits by presenting deviation and GMP investigation records.
Proactively engage with deviation events to perform remediate action immediately to prevent any product impact.
* Leading investigations by generating a root cause analysis team collaborating with different departments.
* Working cross-functionally by efficiently communicating deviation statuses and issues with relevant departments and functional heads based on the type of deviation events.
* Performing on-the-floor investigations.
* Training, coaching and mentoring junior investigators on investigation approaches and the technical details of manufacturing processes.
* Supporting junior investigators' investigations by reviewing reports and providing technical feedback.
* Supporting requests related to deviations or manufacturing issues during global regulatory inspections or audits.
Desired Skills & Experience
* 7+ years working experience in an upstream cell culture or downstream purification MSAT or process development position for the manufacturing of monoclonal antibody therapeutics or Antibody Drug Conjugates (ADCs).
* BS, MS or Ph.D. in Chemical Engineering, Biochemistry, Biology, Chemistry or related Engineering or Life Sciences degree.
* Experience leading deviation inspections and Corrective and Preventative actions for upstream and downstream drug substance manufacturing of commercial monoclonal antibody therapeutics or Antibody Drug Conjugates.
* Knowledge and expertise of GMP Quality Systems and Global FDA & EMA Regulatory Guidelines.
* Knowledge and expertise in drug substance manufacturing processes such as upstream mammalian cell culture and downstream purification.
* Experience supporting FDA, EMA and other Global regulatory audits and inspections.
*** Please note that this is a full-time Expat Opportunity Based in South Korea. It is not based in the US or remote from the US. A full Expat Benefits package is provided including a company paid apartment, international school tuition and relocation assistance. ***
Expatriate Benefits Package:
* 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 - 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 9th years. Many have been promoted 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 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, trips to the US is easy and Asia travel opportunities are endless.
You can also view new photos of Korea and Songdo at
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