Job Description
Job Summary:
- This laboratory-based position supports the Vaccine Research & Development (VRD) Analytical GLP Laboratory team.
- The successful candidate will perform routine sample testing, analytical method verification and qualification activities, in support early-phase vaccine toxicology studies within a highly regulated Good Laboratory Practice (GLP) environment.
- The ideal candidate will have prior pharmaceutical or biotechnology laboratory experience, strong documentation skills, and the ability to work collaboratively within a small, highly engaged analytical team.
- This role offers a balanced workload consisting of approximately:
- 50% laboratory-based analytical testing.
- 50% data analysis, documentation, and report writing.
Duties and Responsibilities:
- Perform routine sample testing in support of GLP release and stability studies for vaccine candidates.
- Execute analytical method verification and qualification studies under guidance.
- Prepare samples, operate analytical instrumentation, and generate high-quality data.
- Analyze experimental results and document findings in compliance with GLP and Good Documentation Practices (GDP).
- Record laboratory activities contemporaneously using Electronic Laboratory Notebooks (ELN).
- Draft, review, and revise laboratory methods, reports, and technical documentation.
- Support assay transfer, training activities, and method implementation.
- Plan and prioritize daily laboratory activities to meet project timelines.
- Follow laboratory procedures, safety requirements, and compliance standards.
- Participate in laboratory maintenance activities, including equipment upkeep and laboratory housekeeping.
- Communicate testing issues, deviations, and observations appropriately to management.
Education:
- Bachelor’s degree in chemistry, Biochemistry, Biology, Biophysics, or another Life Sciences discipline with 2+ years of relevant experience; OR
- Master’s degree in a related scientific discipline with 0–2 years of experience.
Experience Preferred:
- At least one year of pharmaceutical, biotechnology, or industrial laboratory experience.
- Experience working in a regulated environment (GLP, GMP, or similar).
- Familiarity with compliance-driven laboratory operations and documentation practices.
- Academic laboratory experience alone may be considered; however, industry laboratory experience is strongly preferred due to the regulated nature of the work.
Required Competencies:
- Strong written and verbal communication skills.
- Excellent documentation and technical writing abilities.
- Detail-oriented with a strong focus on quality and compliance.
- Ability to analyze data and draw scientifically sound conclusions.
- Strong organizational and time-management skills.
- Willingness to learn and follow established procedures.
- Effective team player with good interpersonal skills.
- Reliable attendance and professional work ethic.
Team Environment:
- Small collaborative laboratory team of approximately 5 scientists/analysts.
- Candidate will receive both compliance training and hands-on laboratory training before independently performing assigned assays.
- Work involves close collaboration with scientists, analysts, and laboratory management in support of vaccine development programs.
Interview Process:
- Initial screening interview with the hiring manager.
- Virtual panel interview with laboratory management and selected team members/scientists.