Job Details
This is an exciting leadership opportunity overseeing the Quality Control Biochemistry team and Analytical Method Transfer group within a leading Contract Manufacturing Organization (CMO). This is a once-in-a-lifetime Global Expat leadership opportunity within the World's Largest biologics CMO expanding to 720 KL total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. Your roles and responsibility will include:
- Providing strategic direction and leadership for the QC Biochemistry team responsible for performing and reviewing chemistry/biochemistry product tests, managing test schedules for drug substance/drug product plants, and stability studies.
- Overseeing Analytical Method Transfer including analytical method development, optimization, transfer, validation, and lifecycle management activities.
- Leading analytical method gap assessments, authoring method implementation master plans (MIMPs), and executing phase-appropriate implementation of analytical test methods for release/stability testing.
- Ensuring the establishment and monitoring of assay performance criteria.
- Managing platform methods in collaboration with CDMO partners.
- Overseeing authoring of chromatography methods, protocols, and reports.
- Leading execution of method transfer, pre-validation, and validation activities.
- Overseeing laboratory control activities, including audit/inspection response and client communication.
- Supporting deviation/CAPA/change control investigations, NCRs, OOTs, and stability protocol reviews.
- Ensuring PAI readiness, supporting BLA/CMC filings and hosting FDA/EMEA audits & inspections.
Desired Skills & Experience:
- BS, MS, or Ph.D. in Biology, Biochemistry, Chemistry, Molecular Biology, or related Scientific field.
- 8+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience from within a large-scale or commercial biologics manufacturing environment.
- Strong leadership and organizational skills for managing cross-functional QC teams.
- Expertise in analytical chemistry techniques (HPLC/UPLC, ICE, CE, UV) and biochemistry analyses (ELISA, qPCR, cell-based assays).
- Experience in analytical method development, optimization, qualification, and validation for biologics.
- Proficiency in stability testing, reference standards management, and assay performance monitoring.
- Knowledge of GMP requirements and industry standards related to analytical methods and QC operations.
*** 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 - 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.