About the role

AI summarised

The Senior Analytical Science & Technology (AS&T) Manager is responsible for end-to-end analytical science and QC laboratory quality systems governance in pharmaceutical API manufacturing. This role leads AS&T and QC systems teams, ensuring analytical method lifecycle management, data integrity, and inspection readiness. The manager partners with Manufacturing, QA, and Digital teams to drive Right First Time outcomes and operational excellence.

BiopharmaFull-time

Key Responsibilities

Lead all Analytical Method Transfer Exercises (AMTE) for APIs transferring into, within, and out of the site.
Own the analytical method lifecycle, including development, validation, verification, compendial review impact assessments, and robustness improvements.
Ensure analytical approaches align with ICH guidance, PQS, and site SOPs.
Provide SME oversight for analytical troubleshooting, method failures, and complex laboratory investigations.
Own and govern QC laboratory quality systems, including deviations, investigations, root cause analysis, CAPA, data integrity, SOP lifecycle, and change management.
Act as system owner / business process owner for core QC laboratory systems, including LIMS/GLIMS and Empower Chromatography Data System.
Ensure systems are qualified, maintained in a validated state, and governed for user access, data integrity, and change control.
Establish and maintain strong Data Governance and Data Integrity controls across analytical and QC systems.
Provide expert analytical and systems input into manufacturing deviations, laboratory OOS/OOT events, system related data integrity issues, and customer complaints.
Support routine API manufacturing by providing real-time analytical expertise to Value Stream Teams (VSTs).
Develop and manage integrated project plans covering analytical method transfers, validation programs, QC systems improvements, and digital initiatives.
Drive Right First Time (RFT) behaviors and lead continuous improvement initiatives leveraging Lean, Six Sigma, SPC, and system harmonization.

Requirements

Bachelor, Master, or Ph.D. Degree in Science (Chemistry preferred), Pharmaceutical Sciences, or related Life Sciences.
Minimum 8 years of experience in pharmaceutical manufacturing or QC, AS&T, or R&D laboratory environments within regulated industries.
Minimum 5 years in a leadership/supervisory position of professional staff or demonstrated capability to successfully lead large teams.
Governance experience with LIMS/GLIMS, Empower, and analytical data systems.
Experience in an API manufacturing plant is preferred.
Extensive knowledge of GMP compliance requirements for Quality Control Laboratories is a must.
Successful track record of continuous improvement, development and/or implementation of best practices in Quality Control Laboratories.