ABOUT HILLEMAN LABORATORIES
Hilleman Laboratories is a Singapore-based vaccine development organization advancing global health through innovative, affordable vaccines and biologics. A joint venture between MSD (Merck Sharp & Dohme) and Wellcome Trust, we develop solutions for infectious diseases with high unmet medical needs and improve existing vaccines through scientific excellence, strategic partnerships, and a commitment to equitable access.
ROLE DESCRIPTION
The Senior Scientist, Analytical Development develops, optimizes, qualifies, troubleshoots, and transfers analytical methods supporting vaccine and biopharmaceutical programs from early development through Phase 1/2 clinical trials.
The role requires strong hands-on expertise in molecular biology-based analytics, including PCR/qPCR/dPCR, sequencing, and nucleic acid characterization, together with a good understanding of viral vaccines and/or mRNA modalities and their analytical characterization. The position combines laboratory execution with scientific leadership, project ownership, mentorship, and cross-functional collaboration.
RESPONSIBILITIES
Analytical Method Development, Transfer & Qualification
- Develop, optimize, qualify, and troubleshoot fit-for-purpose analytical methods supporting product and process development.
- Design analytical strategies, including method selection, experimental design, controls, assay conditions, and acceptance criteria.
- Investigate assay variability and failures and provide scientifically justified conclusions and recommendations.
- Plan and support analytical method transfers to QC, external partners, and other receiving laboratories.
- Prepare and review analytical procedures, SOPs, qualification and transfer protocols/reports, comparability assessments, technical summaries, and regulatory documentation.
- Provide analytical justifications and responses to technical or regulatory queries.
Molecular Biology, Viral Vaccine & mRNA Analytics
- Develop and apply molecular analytical methods, including PCR, RT-PCR, qPCR, dPCR, Sanger sequencing, and next-generation sequencing, to support product characterization and development.
- For viral vaccine modalities, apply appropriate methods for viral identity, genomic identity/integrity and genetic stability, viral genome quantitation, infectivity/titer, and potency, including molecular and cell-based approaches as appropriate.
- For mRNA modalities, apply appropriate methods for mRNA identity, sequence confirmation, integrity, quantity, purity/impurities, and expression/potency, using molecular, electrophoretic, chromatographic, and cell-based approaches as appropriate.
- Evaluate emerging analytical technologies and establish new analytical capabilities based on project needs.
Analytical Testing and Laboratory Operations
- Plan and execute testing of development, characterization, in-process, and other priority samples for Process Development, Manufacturing, and technology-transfer activities.
- Analyze, interpret, and communicate data using appropriate scientific and statistical approaches.
- Balance method development with time-critical testing needs and proactively communicate technical, resource, and timeline risks.
- Maintain accurate and timely laboratory records and support safe, compliant, and efficient laboratory operations.
- Identify opportunities to improve analytical capabilities, efficiency, and compliance.
Scientific Leadership & Project Delivery
- Serve as a senior technical resource within Analytical Development and mentor junior scientists and analysts.
- Provide guidance on experimental design, troubleshooting, data interpretation, and scientific documentation.
- Collaborate with Early Development, Process Development, Manufacturing, QC, Quality, Regulatory Affairs, and external partners, to advance Hilleman programs across modalities (virus, mRNA, bacterial, protein conjugates).
- Communicate analytical results, limitations, risks, and recommendations clearly to technical and non-technical stakeholders.
EDUCATION, EXPERIENCE, KNOWLEDGE & SKILLS
- Advanced degree in Molecular Biology, Virology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Biological Sciences, or a related field, with at least 6 years (PhD), 8 years (Master’s), or 10 years (Bachelor’s) of relevant experience.
- Strong hands-on experience in analytical method development, optimization, qualification, troubleshooting, and transfer in a pharmaceutical, biotechnology, vaccine, or related environment.
- Strong practical expertise in PCR/qPCR/dPCR, sequencing, and nucleic acid characterization.
- Good understanding of viral vaccine and/or mRNA modalities and their associated analytical characterization; experience with either modality is valuable, while experience across both is advantageous.
- Experience with cell-based potency assays and physicochemical analytical methods is advantageous.
- Working knowledge of GMP and phase-appropriate expectations for analytical qualification, validation, transfer, and lifecycle management.
- Demonstrated ability to independently design experiments, interpret data, troubleshoot complex problems, and provide scientifically sound recommendations.
- Strong scientific writing, communication, mentoring, and cross-functional collaboration skills.
- Ability to manage multiple priorities with a high level of ownership, adaptability, and attention to detail.