Senior Scientist
Role: Senior Chemistry Specialist / Scientist (GMP Environment)
Core Responsibilities
- Conduct chemistry testing and analytical activities.
- Perform method verification, transfer, validation, and development.
- Complete technical reviews, data reviews, and batch record audits.
- Manage client communications, meetings, and stakeholder interactions.
- Investigate quality issues, deviations, and exceptions.
- Lead root cause analyses, risk assessments, CAPA, and change controls.
- Support equipment calibration, qualification, and maintenance.
- Write and review SOPs, protocols, reports, and technical documentation.
- Support internal audits, client audits, and regulatory inspections.
- Manage laboratory information management systems (LIMS).
- Drive continuous improvement initiatives.
- Deliver training and provide technical guidance.
- Participate in cross-functional or global working groups.
Essential Requirements
- Strong GMP knowledge and experience.
- Advanced chemistry technical expertise.
- Experience with method validation/development and quality systems.
- Strong report writing and documentation skills.
- Excellent problem-solving and analytical abilities.
- Ability to work independently and collaboratively.
- Leadership and mentoring capabilities.
- Strong communication and stakeholder management skills.
- Customer-focused with a commitment to quality and compliance.
- Experience delivering training.
Additional Information
- Full-time position (39 hours per week).
- Sponsorship not available.