About the Job:

We are seeking highly motivated and innovative Scientist who are passionate about biologic drug development to join us in our fast-growing R&D Lab. The applicant should demonstrate competency in designing and developing assays and leading independent projects, preferably biologics.

ROLES, RESPONSIBILITIES & EXPECTATIONS

• Design, develop, validate, and perform bioassays compliant with FDA/EMA, OECD GLP principles and other regulatory guidelines, which mainly include but not limited to:

- Cell-based potency assays

- Ligand binding assays

- Binding kinetics assays

- ECL based assays

- Cell signaling assays

• Data compilation, interpretation and statistical analysis when required
• Perform studies/assays and ensure data integrity.
• Draft, revise and review study protocols, study reports and SOPs
• Review various types of documents, data and provide scientific input
• Delegate scientific tasks to team members and ensure timelines are met
• Perform literature reviews and provide technical and scientific expertise as required.
• Support the Test Article management team
• Understand study background, objectives, design and criteria, and have a complete understanding/familiarity with investigational drugs to conduct studies in high scientific quality
• Train and mentor junior staff/analysts/interns
• Assist in management and supervision of day-to-day laboratory operations and personnel including lab maintenance and monitoring, study data recording, report and SOP writing
• Participate in dossier writing and CMC activities
• Perform other tasks assigned by the Team Leader/HOD

REQUIREMENTS AND QUALIFICATIONS

• PhD in biomedical science, life science or equivalent
• Proficiency in mammalian cell culture and aseptic techniques is a must.
• Experience in cell-based assays, ligand binding assays such as ELISA and BLI and microscopy techniques is a must.
• Knowledge in SDS-PAGE, Western Blot, flow cytometry and immunostaining is desirable.
• Experience in drafting study protocols, study reports and SOPs
• Experience in method development, method validation, biologic drug characterization and PK & immunogenicity analysis
• Proficiency with LIMS, office management software (MS office, Teams), and statistical tools (Prism, SPSS, or PLA).
• Experience in GLP/GCLP and/or ISO17025 is a plus
• Ability to deliver quality data on time to meet project timelines.
• Outstanding organizational, interpersonal, and oral communication skills are critical.
• Superior attention to detail, problem solving and troubleshooting skills are desirable.