Associate Scientist III - Biosafety Testing

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Your Role:

Reporting into the Lab Manager or Manager-Biosafety Testing, the Associate Scientist III – Biosafety Testing is responsible to perform a wide variety of routine tasks to support GMP operations and primarily focusses on Molecular Biology, NGS and BLAZAR work related to Biosafety Testing. Responsibilities include performing Biosafety assays in both Molecular Biology laboratories which required to characterize product, preparing and qualifying of reagents, monitoring stock levels, and conducting general equipment maintenance to sustain seamless workflow and optimal performance of laboratory equipment.

The Associate Scientist III may require to provide training and / or mentoring junior members of lab personnel. The ability to maintain effective working relationships with Scientists, Lab Scientists, support services, and laboratory personnel will be critical for success in this role.

What You Do:

• Works within the Molecular Biology and NGS laboratories following Standard Operating Procedures and compliance regulations.
• Adherence to Standard Operating Procedures (SOPs) and Compliance Regulations: Ensure all work is carried out according to established protocols and regulatory standards.
• Learning Management System: Ensure zero overdue LMS records, timely complete training required to perform the assay or task.
• Timely Completion of Studies and Record Keeping: Complete routine and custom studies on time, maintaining accurate records that meet scientific and Good Manufacturing Practice (GMP) standards.
• Assay Validations: Perform validations of assays following relevant protocols.
• Document Control: Maintain SOPs, laboratory books, and forms, ensuring outdated versions are removed promptly. Review and improve working documents through document control processes.
• Stock Control and Procurement: Manage stock levels, order consumables, and handle procurement through designated systems.
• Laboratory Maintenance: Conduct housekeeping, equipment checks, and environmental and personnel monitoring to ensure compliance and safety.
• Health and Safety: Maintain a clean, tidy, and safe work environment, adhering to health and safety policies and procedures.
• Training and Mentoring: May require to train and mentor newer or junior members of the lab personnel.
• Quality Audits and Regulatory Compliance: Participate in internal quality audits and regulatory audits as required.
• Audit Readiness: Maintain a constant state of readiness for audits across all laboratory areas.
• Protocol and SOP Development: Author laboratory protocols, SOPs, and workbooks for projects.
• Peer Review and Data Management: Conduct peer reviews of raw data records and ensure accurate data management practices on a timely mannner.
• Deviation/Discrepancies: Raise and progress deviation and Corrective and Preventive Action (CAPA) records promptly.
• Continuous Improvement: Proactively identify and implement improvements to laboratory processes and procedures to enhance efficiency and reduce waste. Site or Global Initiatives: participate in site or global initiatives

Who You Are:

• Minimum Degree in Biological Sciences or higher qualification in relevant scientific subject
• 3 plus years of working experience in biologics or biopharmaceutical industry
• 3 plus years of working experience in a regulated environment (GMP or equivalent)
• 2 plus years of working experience in specific area of expertise (molecular biology, virology, microbiology/mycoplasma) with demonstrated ability to trouble-shoot
• Quality mindset and good understanding of GMP
• Demonstratable experience in implementing projects to set-up/improve lab processes/systems
• Good oral and written communication skills in English
• Capability on problem solving and planning skills
• ERP experience is an asset (Oracle / SAP/ LIMS/ Trackwise)
• Proficient in Microsoft programs (Word, Excel, PowerPoint, etc)
• Adheres to safety SOPs and follows safe work practices
• Always ensures a safe and healthy work environment
• Team player, proactive and willing to take ownership