- Comply with laboratory health and safety standards.
- Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11
- Ability to follow standard operational procedures, apply established principles to maintain services in accordance with NATA/ISO accreditation requirements.
- Process, evaluate, review and interpret data results
- Research, design and develop analytical methods, includes troubleshooting of assays.
- Analyse samples following validated analytical methods.
- Maintain accurate and detailed experimental records, review data, and contribute to technical reports.
- Operate analytical instruments and associated software systems.
- Carry out routine calibration and maintenance of instruments.
- Partake in laboratory housekeeping duties, prepare buffers and reagents.
- Perform quality control checks
- Collaborate closely with project teams, study directors/PI, and QA to ensure timely and high-quality study delivery.
- Train and mentor junior level scientists.
- Drafting/reviewing SOPs, methods and reports.
- Collaborate across teams, departments,
and sites.
- Participate in ongoing laboratory and regulatory training.
- Assists with any additional tasks as assigned by management
Skills, Education & Qualifications
- Bachelors degree or higher with at least 5 years of relevant work experience, or an equivalent combination of education, training, and experience as deemed appropriate by management.
- Ability to work in a fast-paced and dynamic setting.
- Excellent verbal and written communication skills.
- Detail oriented and responsible.
- Ability to work effectively in a team as well as work independently.
- Strong collaboration, time management, and organizational skills.
- Good Microsoft Office skills (Word and Excel).
- Experience with sample handling in an industrial laboratory.
- Good understanding of GLP (FDA, EMA and OECD) and GCP regulations (as applicable), as well as 21 CFR Part 11 (electronic records and electronic signatures).