Senior Manager, QC Compliance and Analytical Methods ...

This is an exciting Expat opportunity responsible for driving the improvement of ELISA & Bioassay QC test methods and analytical methods 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 784,000L total mammalian cell culture manufacturing capacity across 5 plants with commercial monoclonal antibody, Antibody Drug Conjugate, mRNA and C> manufacturing capabilities. Your roles and responsibility will include:• Overseeing the investigation of QC deviations, Non-Conforming results and CAPAs.• Training and mentoring QC analysts on the troubleshooting of ELISA, Bioassays and Biochemistry Analysis (ELISA, qPCR, Cell Based Assays).• Driving the root cause analysis and troubleshooting of atypical results in QC test methods including ELISA and Bioassays. • Overseeing analytical methods 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 client partners.• 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 or MS 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.• Expertise in analytical methods and biochemistry analyses (ELISA, qPCR, cell-based assays).• Experience in analytical method development, optimization, qualification, and validation for biologics.• Strong technical troubleshooting expertise applying root cause analysis, failure analysis and methods improvement.• 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 - 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 levelsWork 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.

Created: 2025-02-09