Senior Associate Scientist, Microbiology

WuXi XDC; Singapore; On-site; SGD 40,000 - 64,000; Full time

Job summary

WuXi XDC seeks a microbiology professional to join the QC team, performing microbiological testing of raw materials, intermediates, in-process and finished products under cGMP conditions. The role supports calibration, maintenance, method transfer and data integrity throughout the lab.

The ideal candidate holds a Bachelor in Microbiology/Life Sciences with 1–2 years in pharma/medical devices labs and familiarity with major pharmacopoeias and GMP guidelines.

Qualifications

• Bachelor Degree in Microbiology, Biology, Biotechnology, Life Sciences or equivalent.
• 1–2 years of pharma/medical devices lab experience preferred.
• Familiar with PICS, ICH, Singapore HSA, FDA, EMA, NMPA, WHO pharmacopoeias, USP, Eur.P, ChP.

Responsibilities

• Perform quality control microbiological testing of raw materials, in-process, and finished products.
• Monitor and test the facility and utilities system.
• Coordinate calibration, preventive maintenance, and repairs of lab instruments.
• Support aseptic process simulations and method development/validation.
• Maintain ALCOA data integrity and laboratory records.
• Maintain laboratory housekeeping using 5S principles.
• Escalate investigations for accidents or policy breaches.

Skills

Quality control testing

ALCOA principles

5S housekeeping

Documentation

Laboratory data integrity

Education

Bachelor degree in Microbiology/Life Sciences

Job description

• To perform quality control microbiological testing of raw materials, incoming goods, intermediates, in-process, drug substance, and/or finished products under cGMP conditions for QC release or part of stability studies
• To perform monitoring and testing for the facility and utilities system
• To perform and coordinate calibration, preventative maintenance and repairs or laboratory instruments/equipment
• To support aseptic process simulations
• To support microbiological method transfer/development/validation/verification/suitability
• To perform periodic review for laboratory documents
• To manage microbiological inventory required for sampling and testing
• To ensure adherence to ALCOA principles for managing laboratory data
• To adhere to site/job role training plan, and maintain individual training records
• To maintain laboratory housekeeping using 5S approach
• Ensure timely escalation of investigations accidents, near misses and breaches of policies
• To carry out tasks required by the reporting Manager

Requirements:

• Bachelor Degree in Microbiology, Biology, Biotechnology, Life Sciences or equivalent.
• 1-2 years of experience in the pharmaceutical or medical devices industry, with experience on working in a laboratory environment preferred
• Familiar with PICS, ICH, Singapore HSA, FDA, EMA, NMPA, WHO technical guideline and USP, Eur.P, ChP pharmacopoeias.
• Preferred to have knowledge on GMP manufacturing.