Analytical Sciences & Technology Analyst
The AST Analyst will be responsible for delivering analytical projects in line with business needs while ensuring compliance with current Good Laboratory Practices (cGLP). This role requires collaboration with key internal stakeholders, including Quality Control (QC), Quality Assurance (QA), Manufacturing Sciences, and other technical departments, to support analytical chemistry expertise and method development activities.
Key Responsibilities
- Provide analytical chemistry expertise to AST-MSAT and site-wide activities.
- Engage with internal departments to facilitate project execution and troubleshooting.
- Participate in the development, qualification, and optimization of analytical methods.
- Support method transfer activities as required.
- Contribute to analytical and functional method improvements.
- Research and propose innovative analytical advancements.
- Assist with investigations and troubleshooting analytical challenges.
- Train analysts in new methods and techniques.
- Communicate project updates and identify improvement opportunities to the AST Team Leader.
- Ensure all quality documentation is complete, accurate, and up-to-date.
- Maintain laboratory areas in compliance with cGLP standards.
- Ensure adherence to defined procedures and regulatory requirements.
- Validate critical chemical testing methods and related equipment.
- Uphold safety and compliance standards to the highest level.
- Maintain internal/external audit readiness.
- Ensure compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP).
- Ensure training compliance for self and team members.
Qualifications & Experience
- Bachelor’s degree in Science (Chemistry or Biochemistry preferred).
- Experience in a laboratory environment, ideally in the pharmaceutical or biopharmaceutical sector.
- Experience in leading people or projects.
Skills & Knowledge
- Hands-on experience in quality laboratories within a fast-paced manufacturing environment.
- Strong knowledge of quality management systems, cGLP, pharmacopeial methods, and stability testing.
- Familiarity with compliance regulations in pharmaceutical manufacturing.
- Ability to manage projects within scope, timeline, and budget.
- Understanding of Key Performance Indicators (KPIs) relevant to the site.
