Senior Analytical Scientist (Regulatory Testing Operations)

Technical Execution & Capability Development:

• Perform and supervise biologics testing including cellular, immunological, molecular and analytical assays, review results, and interpret data to prepare test reports.
• Lead method transfers from manufacturers, establish and validate test methods for regulatory testing of biologics.
• Plan and execute research projects to enhance laboratory capabilities and develop new test methods for accreditation.
• Review vaccine lot release submissions, assess batch compliance, and investigate product complaints or adverse reactions.
• Identify laboratory capability gaps and propose actionable improvement plans.
• Support transformation projects using AI or automation tools to enhance lab productivity.

Consultancy & Leadership

• Provide expert scientific opinions related to biologics testing to clients and stakeholders.
• Evaluate training programs and provide technical guidance to junior scientists and students.
• Represent the laboratory at local and international conferences, meetings, professional forums, and cross-functional collaborations.

Quality & Safety

• Prepare, review and update Standard Operating Procedures (SOPs), laboratory manuals, and relevant test and instrumental qualification and maintenance records to ensure quality system compliance to ISO17025 standards and relevant international guidelines.
• Assist in administrative tasks to ensure smooth laboratory operations.

• Strong background in Life Sciences, Biomedical Sciences, Biochemistry, or a relevant scientific discipline.
• Minimum of 7 years of working experience in laboratory testing of biologics or relevant pharmaceutical industry.
• Deep understanding of ISO17025, Good Laboratory Practice (GLP), and international guidelines for quality management system.
• Demonstrated knowledge of vaccine lot release processes and regulatory frameworks.
• Hands-on mastery of PCR/qPCR/ddPCR, ELISA, NGS, cellbased potency assays (cytotoxicity, flow cytometry) and analytical techniques such as HPLC, LC-MS and CGE analysis for biologics products.
• Strong skills in biostatistics and data analysis software.
• Experience in bioinformatics for identification of microbiological organisms in complex biologics products combined with wet lab validation is advantageous.
• Experience in AI/ML applications in biologics testing is advantageous.
• Proven ability to manage projects, lead workgroups, and mentor technical staff.
• Exceptional problem-solving skills with meticulous attention to detail during investigations.
• Excellent communication skills for client and stakeholder consulting and cross-functional teamwork.
• Ability to work independently, manage multiple high priority projects, and adapt rapidly to changes in workplace.