Total 3 job vacancies by Pfizer Asia Manufacturing Pte. Ltd.

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.

Use Your Power for Purpose

Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need.

What You Will Achieve

In this role, you will:

• Coordinate the manufacture of key API (Active Pharmaceutical Ingredients) Intermediate processes and ensure flawless execution focusing on safety, quality, supply, and cost.
• Provide essential technical support to process teams to sustain and enhance the processes, including diagnosing and rectifying faults within the API manufacturing Control Systems.
• Develop and implement Cost Improvement Projects (CIP) to enhance efficiency and reduce costs.
• Contribute to moderately complex projects, managing your own time to meet targets and developing plans for short-term work activities.
• Provide technical support to sustain and improve changeover processes on site, collaborating closely with Operations, Safety, Engineering, Quality Operations, and Value Stream Teams.
• Coordinate the tech transfer of processes and technologies to other international API sites, utilizing site business processes to support and monitor the Change Over process effectively.
• Support the talent development strategy at Pfizer sites, ensuring continuous improvement and excellence in all operations.

Here Is What You Need (Minimum Requirements)

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
• Demonstrated ability to deliver improvements to site performance using Lean and Six Sigma tools
• Understanding of regulatory standards and guidance documents as well as evolving cGMPS impact pharmaceutical production
• Strong technical, analytical, and problem-solving skills with the ability to make timely decisions
• Proficiency in using communication tools and techniques to explain complex issues and establish consensus among teams

Bonus Points If You Have (Preferred Requirements)

• Relevant pharmaceutical experience
• Strong project management skills
• Excellent interpersonal and communication skills
• Ability to mentor and guide other colleagues
• Experience in diagnosing and rectifying faults within manufacturing control systems
• Knowledge of Good Manufacturing Practices (cGMP)

Work Location Assignment: On Premise

Responsibilities : 

• Perform analytical method transfer, method validation, method verification and method equivalency study in accordance to Standard Operating Procedures (SOPs), adhering to ALCOA principles and Data Integrity requirements. 
• Perform analytical testing accurately and efficiently following Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements. 
• Use Imex "ways of working" for day-to-day operations, problem solving, escalation and continuous improvements. 
• Participate in 5S team initiatives and practice good housekeeping, ensuring all safety procedures are followed. 
• Assess impact to products based on compendial monograph changes/updates/introduction. 
• Support regulatory submissions and queries for post transfer activity. 
• Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory. 
• Conduct Laboratory investigations and propose CAPA for the identified root cause. 
• Train colleagues in hands on training of instruments and methods written 
• Perform review and approval of test results. 
• Able to write position paper, protocols, reports and test procedures. 
• Ability to handle QTS actions and raise and complete change controls for changes with GMP impact.
• Involve in regular meeting with donating site and facilitate the smooth transfer of the methods. 
• Conduct trainings for fellow QC colleagues on new methods in the laboratory. 
• Contribute to the continuous improvement activities in QC laboratory or cross functional teams as nominated. 
• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting issues, with appropriate escalation. Support development and implementation of solution.
• Perform cleaning method development and validation. 
• Ensure following the site GDP practice on documentation and preparation of document. 
• Method verification in accordance to site or pharmacopeia standards and according to schedule. 
• Ensure training records are updated and promptly, are correctly filed to reflect current testing capabilities.

Job Skill Requirements:

• Min. Degree with 5 years of QC Experience in pharmaceutical or related industries
• Demonstrated technical skills in method transfer, validation, verification and testing.
• Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures and governmental regulations
• Experienced in Method Transfer, Method Validation and Method Verification activity.
• Knowledge of cGMPs and ALCOA principles.
• Laboratory work experience with analytical HPLC, GC, FTIR, UV, KF and other lab equipment.
• Experienced in leading continuous improvement projects
• Knowledge of lean manufacturing, six sigma methodologies, and statistics