Job Details
Validation Engineering Manager, ADC Manufacturing - Songdo, South Korea
This is a stellar opportunity responsible for leading ADC Validation Engineering processes and serving as a SME for ADC manufacturing. This is a once-in-a-lifetime Global Expat leadership opportunity within the World s Largest biologics CMO expanding to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. You will be charged with overseeing the following activities:
* Serving as a SME for Antibody Drug Conjugate equipment validation, facility validation and cleaning processes.
* Serving as a SME for Isolator equipment qualification and containment performance assessment and verification.
* Generating and maintaining Validation Master Plans and Revalidation plans.
* Authoring and generating essential validation documents including validation protocols, validation reports and test plans to support facility startup and tech transfer of ADC products.
* Updating and generating validation policies and procedures to incorporate ADC validation practices into the site validation program.
* Implementing the site Antibody Drug Conjugate containment verification program including training of personnel, revalidation and certification processes.
* Supporting Global Regulatory Agency inspections and audits.
Preferred Candidate Background and Expertise:
* 8+ years working experience with ADC biopharmaceuticals, including manufacturing process development.
* BS or MS in Biochemistry, Biology, Chemistry, Chemical Engineering, Mechanical Engineering or related Life Sciences or Engineering field.
* Solid understanding of ADC manufacturing processes and equipment and risk assessments.
* Expertise in validation for ADC manufacturing including setting up containment performance targets, verification of containment performance, cleaning requirements for ADC manufacturing and isolator qualification processes.
Understanding of ADC regulatory requirements and technical standards such as ISPE guideline for Assessing the Particulate Containment Performance of Pharmaceutical Equipment.
* Familiarity with FDA and cGMPs for ADC manufacturing.
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 - 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.