About the role
AI summarisedThe Senior Analytical Science & Technology Manager holds end-to-end accountability for analytical science and QC laboratory quality systems governance, ensuring robust analytical execution, compliant laboratory operations, and sustained inspection readiness to support API manufacturing. This role integrates AS&T leadership with QC Quality Systems ownership, serving as the technical authority for method lifecycle management, investigations, and data integrity across core laboratory systems.
BiopharmaOnsite
Key Responsibilities
- Lead all Analytical Method Transfer Exercises (AMTE) for APIs moving through the site.
- Own the analytical method lifecycle, including development, validation, verification, and robustness improvements.
- Govern QC laboratory quality systems, including deviations, investigations, CAPA definition, and data integrity controls.
- Serve as the expert escalation point for audits and inspections concerning laboratory systems, data integrity, and analytical practices.
- Provide expert technical input into manufacturing deviations, OOS/OOT events, and customer complaints.
- Drive Right First Time (RFT) behaviors through continuous improvement initiatives leveraging Lean, Six Sigma, and SPC.
- Lead, coach, and develop AS&T and QC Systems teams while fulfilling First Line Leader responsibilities.
Requirements
- Minimum 8 years of experience in pharmaceutical manufacturing, QC, AS&T, or R&D laboratory environments within regulated industries.
- Minimum 5 years in a leadership/supervisory role with demonstrated capability to lead large teams.
- Extensive knowledge of GMP compliance requirements for Quality Control Laboratories is mandatory.
- Proven governance experience with analytical data systems such as LIMS/GLIMS and Empower Chromatography Data System.
- Proven track record in successful continuous improvement initiatives within QC Laboratories.
- Bachelor's, Master's, or Ph.D. Degree in Science (Chemistry preferred), Pharmaceutical Sciences, or related Life Sciences.