Kerja Sepenuh Masa, Scientist, Analytical Development di Hilleman Laboratories - Maukerja

ABOUT HILLEMAN LABORATORIES

• Hilleman Laboratories is a Singapore-based vaccine development organization dedicated to advancing global health through innovation. We develop novel vaccines and biologics for infectious diseases with high unmet medical needs and adapt existing vaccines with improved technologies to enhance access in low- and middle-income countries.

• A joint venture between MSD (Merck Sharp & Dohme) and Wellcome Trust, our mission is to develop affordable, high-quality vaccines through scientific excellence, strategic partnerships, and a commitment to equitable access.

ROLE DESCRIPTION

The Scientist, Analytical Development is responsible for planning and executing analytical testing, method development, and assay transfer activities to support biologics and vaccine programs from early development through Phase 1/2 clinical trials.

The role applies strong scientific and hands-on expertise in the design, development, and qualification of analytical methods across modalities including viral, mRNA, and protein-based vaccines and therapies.

• Working in a multidisciplinary environment, you will take ownership of project-level deliverables and collaborate closely with Early Development, Process Development, Quality Control, and external partners to ensure analytical readiness, regulatory compliance, and timely progression of programs.

RESPONSIBILITIES

Analytical Development

• Plan and deliver analytical development activities aligned with CMC and program strategy
• Develop, optimize, and troubleshoot analytical methods using internal expertise, literature, and industry best practices
• Prepare and review assay transfer documentation (protocols, reports, comparability assessments, acceptance criteria, regulatory sections such as IND/IMPD)
• Act as analytical point of contact during method transfers, ensuring successful implementation and resolution of technical issues
• Support regulatory submissions and interactions with analytical justifications, validation data, and responses to queries

Analytical Testing

• Plan and execute analytical testing for in-process controls, release testing, and product characterization
• Support Early Development, Process Development, and Tech Transfer activities with timely and high-quality data generation
• Analyze, interpret, and communicate experimental data using appropriate scientific and statistical approaches, including assay variability assessment
• Prepare protocols, reports, and technical summaries with clear scientific conclusions
• Apply scientific judgment for troubleshooting, method selection, and continuous improvement

Lab operations

• Execute routine laboratory responsibilities including housekeeping, equipment maintenance, calibration, and ensuring material readiness
• Maintain accurate, complete, and timely documentation in lab notebooks and electronic systems
• Draft and review SOPs and technical documents to ensure alignment with current practices and compliance requirements
• Identify operational gaps and propose well-justified improvements to enhance efficiency and compliance
• Ensure safe, compliant, and efficient day-to-day lab operations within assigned areas
• Support departmental and cross-functional initiatives as required

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

• Degree in Life Sciences or a related discipline, with a minimum of 2 (PhD), 4 (Master’s), or 6 (Bachelor’s) years of relevant industry experience.
• Strong scientific expertise in molecular biology (e.g., qPCR) and cell-based potency assays; experience with physicochemical analytical methods is advantageous.
• Working knowledge of GMP and regulatory expectations for analytical method validation and lifecycle management; at least 2 years of experience in a pharmaceutical or biotech environment preferred.
• Experience in assay transfer (e.g., from development to QC and/or to external partners such as CMOs/CROs) is advantageous.
• Strong scientific writing and verbal communication skills, with the ability to clearly interpret and present complex data.
• Proven ability to manage multiple priorities effectively in a fast-paced, matrixed environment.
• Highly motivated, detail-oriented team player with a strong sense of ownership and adaptability.