Associate Scientist II

Your Role

The Associate Scientist II – Biosafety Testing is responsible to perform a wide variety of routine tasks to support GMP operations and primarily focusses on Molecular Biology, Virology and Cell Culture work related to Biosafety Testing. Responsibilities include performing Biosafety assays in both Molecular Biology and Virology laboratories which required to characterize product, maintenance of cell culture detector cell lines, 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 II 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.

Training will be provided upon onboarding to ensure you are train to qualify level before performing any routine testing.

What You Do

You should be able to perform the following functions independently, with minimal guidance.

• Works within the Molecular Biology, Virology, and Cell Culture 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.
• Assays transfer: Perform assays transfer following relevant protocols as required.
• Document Control: Maintain SOPs, laboratory books, and forms, ensuring outdated versions are removed promptly.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

The above list of job functions is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post. Job descriptions will be regularly reviewed to ensure they are an accurate representation of the post.

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

Knowledge and Skills:

• 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

Behaviours:

• Obsessed with Customers and Patients: Improve lives, act ethically, ensure quality and create customer value
• Be Curious and Innovate Boldly: Anticipate opportunities, be entrepreneurial, go digital and apply technology
• Act as the Owner: Be open minded, work with agility, unlock creativity and implement change
• Simplify and Act with Urgency: Give feedback, drive performance, be efficient, take responsibility
• Disagree openly, Decide and Deliver: Include others, build networks, teamwork and think global
• Raise the Bar: Develop talents, foster potential, give vision and share emotions

ADDITIONAL LOCAL NEEDS

• Flexibility to work overtime or shifts to cover Business spikes/ needs when necessary.
• Working on Public Holiday (except weekends) for on-going studies.