What you will do:
Define and Execute Production Strategies
Balance customer demand, cleanroom requirements, and business priorities. Make clear, documented decisions when production volume, raw material availability, or compliance requirements conflict.
Production Scheduling & Resource Coordination
Collaborate with Material Planner and S&OP teams to build and revise production schedules considering raw material constraints, validation requirements, and capacity limitations. Manage operator staffing and shift planning.
Documentation & Regulatory Compliance
Ensure accurate completion of batch records, deviation reports, and process documentation. Maintain audit readiness and strict adherence to GMP, biohazard, and cleanroom protocols.
Equipment & Shop Floor Leadership
Oversee equipment qualification, preventive maintenance, and troubleshooting. Actively support shop-floor operations during peak demand or critical situations to maintain safety, quality, and delivery targets.
Continuous Improvement & Lean Practices
Monitor KPIs (productivity, yield, waste, on-time delivery, quality metrics) using ERP and data analytics. Apply Lean principles (e.g., waste elimination, standard work, visual management) to drive efficiency, reduce cost, and foster a culture of continuous improvement.
Who you are:
- Bachelor’s degree in Industrial/Chemical Engineering, Biotechnology, Logistics or related field.
- Minimum 10 years of experience in operations/production management in life sciences or biopharma, with proven ability to manage schedule vs demand conflicts and ensure compliance with regulatory, quality, and cleanroom standards.
- Strong technical expertise in biologics manufacturing: batch processing, material flow, equipment qualification, process validation, cleaning/sanitization, deviation/CAPA management, and containment in cleanroom operations.
- Excellent decision‑making & prioritization skills; able to operate under pressure, manage trade‑offs transparently, and lead cross-functional teams with clear, effective communication. Hands-on leadership when required for critical shop-floor situations.
- Proficiency in ERP systems (SAP, Oracle), strong data analytics / forecasting / reporting skills; demonstrated experience with continuous improvement methodologies (Lean, Six Sigma, Kaizen, etc.).
Travel, Motor Vehicle Record & Physical/Language/Environment Requirements:
- Fluent level of English & Korean in written and verbal communications
- Ability to travel abroad upon business needs
- Must have a valid driver’s license with an acceptable driving record within territory or locations
- If foreign national, legal work permit is required to pursue employment contract by Korean immigration law
- Ability to lift, move or carry equipment up to 30lb, any other physical requirements
It would be a plus if you also possess previous experience in:
- CPIM, CSCP or related professional certification. Strong familiarity with safety, environmental, health (EHS) compliance relevant to biologics/cleanroom environments; experience in biosafety / containment, cleaning validation, or contamination control.
- Experience in tech transfer, commissioning, qualification / validation (IQ / OQ / PQ) of equipment / facility for biologics manufacturing.
- Prior leadership experience in cross‑functional continuous improvement projects, cost optimization initiatives, or waste/yield improvement in a biologics or biopharma environment.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
