Principal Quality Control Microbiologist, Expat in South Korea - Los Angeles Metropolitan Area

This is an exciting Global Expatriate opportunity responsible for leading Quality Control microbiology activities within a state-of-the-art biopharmaceutical manufacturing facility. Initially an individual contributor within the QC Bioassay and Microbial Support function, this ro ...

Job description

This is an exciting Global Expatriate opportunity responsible for leading Quality Control microbiology activities within a state-of-the-art biopharmaceutical manufacturing facility. Initially an individual contributor within the QC Bioassay and Microbial Support function, this role will evolve into a leadership position overseeing QC microbiology testing and contamination control programs. Your roles and responsibilities will include:

Environmental & Utility Monitoring Program Development

• Design, implement, and validate environmental and utility monitoring programs aligned with global regulatory standards (FDA, EMA, USP, EP, JP).
• Establish sampling procedures and select monitoring points based on risk assessments, facility design, and product requirements.
• Interpret microbiological data using statistical tools and recommend improvements.

Contamination Control & Process Microbiology

• Serve as the site's SME for contamination control strategy and aseptic best practices.
• Provide input on facility design, material/personnel flow, and contamination risk mitigation.
• Establish robust contamination prevention procedures for manufacturing processes.
• Perform microbial identification testing and lead microbiological deviation investigations (e.g., OOS, OOT, OAL).
• Support risk assessments of raw materials, intermediates, and finished products.

QC Microbiology Oversight & Readiness

• Establish and refine microbiological QC testing practices and protocols.
• Collaborate with QA, Manufacturing, Validation, and Engineering teams to ensure QC readiness.
• Guide the implementation of microbiological standards across the organization.

Compliance & Audit Support

• Ensure alignment with cGMP and international microbiology regulations.
• Represent microbiology programs during internal and external audits.
• Develop and maintain microbiology-related SOPs, validation protocols, and reports.

Training & Knowledge Transfer

• Develop and conduct microbiology training for cross-functional teams.
• Drive knowledge-sharing of microbiology best practices and compliance expectations.

Technology & Innovation

• Evaluate and implement advanced microbiological testing technologies and methods.
• Monitor emerging trends and regulatory expectations to future-proof contamination control practices.

Desired Skills and Experiences:

• Bachelor's, Master's, or Ph.D. in Microbiology, Biology, Biochemistry, or related life sciences field.
• 10+ years of experience in a GMP-regulated biopharma environment with emphasis on QC microbiology and contamination control.
• Proven track record in developing and implementing EM programs and microbiological quality systems.
• Experience in facility startup, tech transfer, or commissioning & qualification highly desirable.
• In-depth knowledge of microbiology-related regulatory standards (USP, EP, JP, FDA, EMA).
• Familiarity with risk assessment tools and microbiological statistical data interpretation.
• Excellent cross-functional communication and leadership skills.

*** 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).

* 3-4 weeks of vacation time.

* 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