Pfizer
Scientist-Chemistry-Analytical
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Lead global application support and operations for manufacturing systems (MES, labeling, edge). Manage incident/problem/change processes, drive support transitions, SLA performance, root cause analysis, continuous improvement, automation and AI adoption, and coordinate cross-functional technical issue resolution.
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Perform clinical data monitoring and management activities: data review, query management, investigate logic checks, and ensure database design quality through documentation, testing, validation, and implementation of data collection tools. Act as first point of contact for CTMS issues, follow SOPs, collaborate to resolve TMF/document discrepancies, and contribute to process improvements and project work.
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Responsibilities & Duties:
1.1 Compliance and Quality
1.2 Analytical Development and Troubleshooting
1.3 Documentation, Governance, and Review
1.4 Cross-Functional Coordination
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
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
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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