Job Description

Responsibilities & Duties:

1.1 Compliance and Quality

• Perform all activities in compliance with GxP requirements.
• Follow quality and safety requirements in accordance with organizational policies, procedures, and regulatory guidelines.
• Ensure technical outputs align with Global Training Curricula for instrument operation, material handling, and certifications related to Quality Operations, Manufacturing, and EHS.

1.2 Analytical Development and Troubleshooting

• Troubleshoot analytical issues related to methods and instrumentation.
• Develop and validate analytical methods using LC-MS, GCMS and ICP-MS for E&L work flow and Nitrosamine work flow support.
• Develop GTI impurity methods using LC-MS and GC-MS.
• Assess existing data packages, evaluate feasibility, and recommend remediation where needed.
• Has strong knowledge of USP, PQRI, and BPOG guidelines for SUS and MUS systems, along with expertise in writing non-laboratory, paper-based assessment reports for packaging commodities.

1.3 Documentation, Governance, and Review

• Work with Quality Assurance and cross-functional teams to support consistent and disciplined execution of the LIR/ER/CAPA quality system, ensuring assigned tasks are complete and thorough.
• Maintain compliance with local and corporate procedures and keep all data packages audit-ready and transferable.
• Ensure formal milestone reports receive appropriate GT and ELT review to support decision-making.

1.4 Cross-Functional Coordination

• Ensure formal milestone reports receive appropriate GT and ELT review to support decision-making.

Educational Qualification & Work Experience:

Preferred Qualification: Master's in chemistry/pharmacy/Ph.D

Type of Experience: Brings 5–7 years of experience in Analytical Research and Development, with strong expertise in nitrosamine workflow support and extractables and leachable studies. Demonstrates hands-on proficiency in HPLC, GC, GCHS, and LCMS within GMP environments, supported by strong data interpretation and technical report-writing skills.

Knowledge and skills

Technical Skills - LCMS, GCMS and wet Chemistry / HPLC and GC - Advanced

Standards, Processes and Policies - GDP / GLP/cGMP/SOP - Intermediate

Behavioral/Any Other Skills - Think Big / Speak up /Be decisive /Focus on what matters

Agree who does what /Measure Outcomes /Be inclusive /Act with integrity /Take pride

Recognize one another

Work Location Assignment: On Premise

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

Research and Development