The Senior Analytical Science & Technology Manager is accountable for end-to-end analytical science and QC laboratory quality systems governance, ensuring robust analytical execution, compliant laboratory systems, and sustained inspection readiness in support of API manufacturing.
This role integrates Analytical Sciences & Technology (AS&T) leadership with QC Quality Systems and Laboratory Systems ownership, providing a single point of accountability for analytical method lifecycle management, laboratory investigations, data integrity, and computerized laboratory systems.
The incumbent ensures that analytical methods, laboratory processes, and core QC systems (e.g. LIMS/GLIMS, Empower, Lab X) are scientifically sound, compliant, effectively governed, and fit for routine operations, investigations, and regulatory submissions. Acting as both technical authority and QC systems owner, the role partners closely with Manufacturing, QA, Global Analytical functions, and Digital teams to deliver Right First Time (RFT) outcomes and operational excellence.
Responsibilities
1. Analytical Sciences & Technology (AS&T) Leadership
- 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.
2. QC Quality Systems & Laboratory Systems Ownership
- Own and govern QC laboratory quality systems, including:
- Deviations, investigations, and root cause analysis
- CAPA definition and effectiveness
- Data Integrity governance
- SOP lifecycle management
- Change management impacting analytical methods and laboratory systems
- Act as system owner / business process owner for core QC laboratory systems, including:
- LIMS / GLIMS (sample management, result reporting, data integrity)
- Empower Chromatography Data System (method control, data review, user access, audit trail oversight)
- Ensure systems are:
- Qualified and maintained in a validated state
- Appropriately governed for user access, data integrity, and change control
- Fit for business use and inspection ready
3. Data Integrity & Compliance Governance
- Establish and maintain strong Data Governance and Data Integrity controls across analytical and QC systems.
- Ensure compliant use of LIMS/GLIMS, Empower, and associated analytical platforms in line with:
- cGMP, ALCOA+ principles
- PQS and site procedures
- Regulatory expectations (e.g. FDA, EMA)
- Serve as the QC Systems escalation point for audits and inspections involving laboratory systems, data integrity, and analytical practices.
4. Investigation & Manufacturing Support
- Provide expert analytical and systems input into:
- Manufacturing deviations
- Laboratory OOS/OOT events
- System related data integrity issues
- Customer complaints requiring analytical assessment
- Ensure investigations are scientifically robust, risk based, and inspection defensible.
5. Operational & Manufacturing Interface
- Support routine API manufacturing by providing real-time analytical expertise to Value Stream Teams (VSTs).
- Ensure analytical and system readiness for:
- Cleaning validation
- Stability programs
- New product introductions
- Partner with QA, Manufacturing, Validation, and Digital teams to align analytical execution, systems capability, and regulatory submissions.
6. Project, Resource & Financial Management
- Develop and manage integrated project plans covering:
- Analytical method transfers
- Validation programs
- QC systems improvements and digital initiatives
- Balance project and routine operational demand through capacity planning and prioritization.
- Co-own QC laboratory operating budget and analytical systems capital planning (e.g. Empower upgrades, LIMS enhancements).
7. Continuous Improvement & System Enablement
- Drive Right First Time (RFT) behaviors across analytical execution and QC systems.
- Lead continuous improvement initiatives leveraging:
- Lean, Six Sigma
- SPC and trending tools
- System harmonization and standardization
- Promote effective use of laboratory systems to improve efficiency, compliance, and data reliability.
8. People Leadership & Capability Building
- Lead, coach, and develop AS&T and QC Systems teams to build sustainable analytical and systems capability.
- Fulfil First Line Leader (FLL) responsibilities, including:
- Coaching and performance management
- Visible GMP presence
- Realtime issue escalation
- Accountability for Data Integrity behaviors
- Actively role model a strong quality, compliance, and ownership culture.
Supervision
- The incumbent is responsible for 2-5 direct reports and 3-8 indirect reports.
Education
- Min. Bachelor or Master or Ph.D. Degree in Science (Chemistry preferred), Pharmaceutical Sciences or related Life Sciences.
Experiences
- 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 previously 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.
