[What the role is]
To lead technical and research activities that deliver quality lot release and biologics testing services, while providing scientific expertise to advance the laboratory's capabilities in testing complex biologics.
[What you will be working on]
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.
[What we are looking for]
- 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.
