Microbiologist 1

We are seeking a highly skilled Microbiologist 1 to join our team at 825 Glaxo Wellcome Manufacturing Pte Ltd. As a key member of our microbiology department, you will be responsible for providing expertise in microbiology and developing monitoring strategies and operation frameworks.

• Develop and implement microbiological monitoring strategies and operation frameworks to ensure compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements.
• Ensure that all site utilities, water, environmental monitoring, and product testing activities are properly analyzed and executed, and the results recorded in full compliance with cGMP and regulatory requirements.
• Work with relevant functions to support method validation/verification for micro-related methods, ensuring that the activities are carried out in accordance with the required standards and procedures.
• Manage external service providers and suppliers for microbiology laboratory services in accordance with GSK requirements.
• Contribute to the formulation and development of the operational framework of the labs, including testing protocols, SOPs, and other operational policies, procedures, and guidelines.
• Supervise, develop, and motivate assigned analysts to help realize their maximum potential and contribute towards achieving the objectives of the department.
• Ensure regulatory compliance, perform L1 audits, and support L2/L3/L4 audits as a Microbiology Subject Matter Expert (SME).
• Ensure timeliness and accuracy of the Compliance review of Pharmacopoeia & ATS and ensure in-place and in-use of the Pharmacopoeia/ATS/QMS requirement.
• Lead or participate in investigations arising from micro-related and utilities investigations, incidents, and accurately assess the impact of the failure to make appropriate recommendations on remedial actions for follow-up.
• Work with relevant R&D groups to support micro-related activities and micro-risk assessment for New Product Introduction, ensuring that the activities are carried out in accordance with the required standards and procedures.
• Work closely with external staff and at line level to enable the localization and transfer of technology/knowledge/methodologies into standard order fulfillment activities.

• Minimum degree in microbiology, chemistry, or life sciences.
• Minimum 3 years of experience in an analytical environment in the pharmaceutical or life sciences industry.
• Experience in GMP.
• Basic knowledge and ongoing awareness of regulatory requirements (includes safety) on controlled environment and water systems.
• Very good knowledge of microbiological test methods.
• Good knowledge of manufacturing processes and plant layouts of GlaxoSmithKline Manufacturing.
• Good communication skills.
• Basic financial management skills.
• People management skills.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced microbiologist looking for a new challenge, please submit your application.