Principal Scientist I, Microbiologist

WuXi XDC; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

WuXi XDC is seeking a QC Microbiology Lead to drive technical leadership and oversight of the QC Microbiology team in a GMP environment. You will oversee environmental monitoring, testing of water, raw materials, and in‑process samples, and manage excursions, investigations, and CAPAs in collaboration with Manufacturing, Engineering, Validation, and Quality.

Strong microbiology expertise and a bias for process improvement are essential.

Qualifications

• Bachelor’s Degree in Microbiology, Chemistry, Biology, Biotechnology, Life Sciences or equivalent.
• Minimum 6 years of GMP lab experience in biopharma or medical devices.
• Proficiency with PIC/S, ICH, FDA, EMA, NMPA, WHO guidelines and pharmacopoeias.
• Proficiency in Quality Risk Management processes.
• Lean Six Sigma knowledge considered an advantage.
• ADC manufacturing experience is a plus.

Responsibilities

• Provide technical leadership and support the Manager in oversight of the QC Microbiology team.
• Lead environmental monitoring, critical utilities, and microbiological testing for water, raw materials, in-process samples, and release testing.
• Establish and manage EM programs, data trending, excursions, and risk assessments.
• Lead investigations, CAPAs, and changes related to environmental control and contamination risks with cross-functional partners.
• Serve as QC SME for microbiology assays, methods, and emerging tech.
• Review data, investigations, and quality decisions; support client discussions on microbiology and quality issues.
• Supervise daily operations, planning, scheduling, training, and performance development of assigned staff.
• Ensure lab activities comply with cGMP, GDP, CFR, PIC/S, and SOPs; review data and reports.

Skills

Leadership

GMP Knowledge

Quality risk mgmt

Data trending

Microbiology expertise

Education

Bachelor’s Degree in Microbiology

Job description

• Provide technical leadership and support the Manager in oversight of the QC Microbiology team.
• Lead aspects of critical utilities, environmental monitoring programs, and microbiological testing for water, raw materials, in-process samples, and product release testing.
• Establish, manage, and continuously improve site environmental monitoring and contamination control programs, including risk assessments, routine testing, data trending, interpretation, and excursion management.
• Lead investigations, change controls, and improvement initiatives related to environmental control and contamination risks, working closely with Manufacturing, Engineering, Validation, and Quality stakeholders.
• Establish and maintain microbiology testing and qualification capabilities; serve as QC SME for microbiological assays, methods, and emerging technologies.
• Provide expert input on data review, investigations, and quality decisions; lead or support client discussions related to microbiology, EM, and quality investigations.
• Support the QC Manager in supervising, planning, and reviewing of daily operations of assigned staff, including work allocation, scheduling, training, performance evaluation, and talent development.
• Ensure laboratory activities and assays are executed in compliance with cGMP, GDP, CFR, PIC/S guidelines, and company SOPs, including critical review and approval of data and reports.
• Author, review, and approve SOPs, validation and qualification documents, specifications, investigations, and quality records; guide teams in deviation, OOS, OOL, and CAPA management.
• Provide operational, technical, and administrative leadership to the Microbiology organization, ensuring effective resource utilization and team performance.
• Collaborate with management to plan and manage manpower, laboratory supplies, and equipment budgets.
• Drive implementation and continuous improvement of QC microbiology processes, focusing on efficiency, compliance, and inspection readiness.
• Ensure effective communication and documentation with internal and external stakeholders, including project teams, clients, and auditors.
• Support additional tasks or strategic initiatives assigned by the QC Manager to advance departmental and site objectives.

Requirements:

• Bachelor’s Degree in Microbiology, Chemistry, Biology, Biotechnology, Life Sciences or equivalent
• Minimum of 6 years of experience working in a GMP laboratory environment in the biopharmaceutical or medical devices industry
• Proficient with PICS, ICH, FDA, EMA, NMPA, WHO guidelines and US/Eur. pharmacopoeias.
• Proficient in Quality Risk Management process
• Skilled in laboratory systems and Quality Management Systems
• Knowledgeable in lean six sigma principles
• Previous laboratory supervisory roles and knowledge in ADC manufacturing is an advantage