Senior Analytical Science & Technology (AS&T) Manager

The Senior Analytical Science & Technology Manager is accountable forend-to-endanalytical 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 integratesAnalytical Sciences & Technology (AS&T)leadership withQC Quality Systems and Laboratory Systems ownership providing asingle point of accountabilityfor analytical method lifecycle management laboratory investigations data integrity and computerized laboratory systems.

The incumbent ensures thatanalytical methods laboratory processes and core QC systems ( Empower Lab X)are scientifically sound compliant effectively governed and fit for routine operations investigations and regulatory submissions. Acting as bothtechnical authority and QC systems owner the role partners closely with Manufacturing QA Global Analytical functions and Digital teams to deliverRight First Time (RFT)outcomes and operational excellence.

Responsibilities

1. Analytical Sciences & Technology (AS&T) Leadership

Lead allAnalytical Method Transfer Exercises (AMTE)for APIs transferring into within and out of the site.

Own theanalyticalmethodlifecycle including development validation verification compendial review impact assessments and robustness improvements.

Ensure analytical approaches align withICH 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 governQC laboratory quality systems including:

o Deviations investigations and root cause analysis

o CAPA definition and effectiveness

o Data Integrity governance

o SOP lifecycle management

o Change managementimpactinganalytical methods and laboratory systems

Act assystem owner / business process ownerfor core QC laboratory systems including:

o LIMS / GLIMS(sample management result reporting data integrity)

o Empower Chromatography Data System(method control data review user access audit trail oversight)

Ensure systems are:

o Qualified andmaintainedin a validated state

o Appropriately governed for user access data integrity and change control

o Fit for business use andinspection ready

3. Data Integrity & Compliance Governance

Establish andmaintainstrongData Governance and Data Integrity controlsacross analytical and QC systems.

Ensure compliant use of LIMS/GLIMS Empower and associated analytical platforms in line with:

o cGMP ALCOA principles

o PQS and site procedures

o Regulatory expectations ( EMA)

Serve as theQC Systems escalation pointfor audits and inspections involving laboratory systems data integrity and analytical practices.

4. Investigation & Manufacturing Support

Provide expert analytical and systems input into:

o Manufacturing deviations

o Laboratory OOS/OOT events

o System relateddata integrity issues

o Customer complaints requiring analytical assessment

Ensure investigations arescientifically robustrisk based andinspection defensible.

5. Operational & Manufacturing Interface

Support routine API manufacturing by providingreal-timeanalyticalexpertiseto Value Stream Teams (VSTs).

Ensure analytical and system readiness for:

o Cleaning validation

o Stability programs

o New product introductions

Partnerwith QA Manufacturing Validation and Digital teams to align analytical execution systems capability and regulatory submissions.

6. Project Resource & Financial Management

Develop and manageintegrated project planscovering:

o Analytical method transfers

o Validation programs

o QC systems improvements and digital initiatives

Balance project and routine operational demand throughcapacity planning and prioritization.

Co-ownQC laboratory operating budget andanalytical systems capital planning( upgrades LIMS enhancements).

7. Continuous Improvement & System Enablement

DriveRight First Time (RFT)behaviors across analytical execution and QC systems.

Lead continuous improvement initiativesleveraging:

o Lean Six Sigma

o SPC and trending tools

o Systemharmonizationandstandardization

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.

FulfilFirst Line Leader (FLL)responsibilities including:

o Coaching and performance management

o Visible GMP presence

o Realtime issue escalation

o Accountability for Data Integrity behaviors

Activelyrole modela strongquality compliance and ownership culture.

Supervision

The incumbent is responsible for 2-5 direct reports and 3-8 indirect reports.

Education

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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.