Scientist – Analytical Chemistry
Company: Pfizer
Location: Chennai, India
Employment Type: Full-Time
Department: Research & Development
Work Location Assignment: On-Premise
Job Requisition ID: 4956778
Position Summary
Pfizer is seeking an experienced Analytical Scientist with expertise in Extractables & Leachables (E&L), Nitrosamine analysis, and analytical method development. The role involves advanced analytical research, troubleshooting, method validation, regulatory compliance, documentation, and cross-functional collaboration within GMP-regulated environments.
Key Responsibilities
1. Compliance & Quality
Perform all laboratory activities in compliance with GxP requirements.
Adhere to quality, safety, and regulatory standards in accordance with organizational policies and procedures.
Ensure technical outputs align with Global Training Curricula requirements.
Maintain certifications and competency related to:
Instrument operation
Material handling
Quality Operations
Manufacturing processes
Environmental Health & Safety (EHS)
2. Analytical Development & Troubleshooting
Investigate and troubleshoot analytical method and instrumentation issues.
Develop, optimize, and validate analytical methods using:
LC-MS
GC-MS
ICP-MS
Provide analytical support for:
Extractables & Leachables (E&L) workflows
Nitrosamine workflows
Develop GTI (Genotoxic Impurity) analytical methods utilizing:
LC-MS
GC-MS
Review and assess existing analytical data packages.
Evaluate study feasibility and recommend remediation strategies when necessary.
Apply strong knowledge of:
USP guidelines
PQRI guidelines
BPOG guidelines
Support SUS (Single-Use Systems) and MUS (Multi-Use Systems) assessments.
Prepare technical and non-laboratory assessment reports for packaging commodities.
3. Documentation, Governance & Quality Systems
Collaborate with Quality Assurance and cross-functional teams.
Support execution of:
LIR (Laboratory Investigation Reports)
ER (Exception Reports)
CAPA (Corrective and Preventive Actions)
Ensure assigned quality-system tasks are completed accurately and thoroughly.
Maintain compliance with local and global corporate procedures.
Keep analytical data packages audit-ready and transferable.
Prepare and review milestone reports for management decision-making.
Ensure appropriate review and approval by Global Teams (GT) and ELT.
4. Cross-Functional Collaboration
Work closely with:
Quality Assurance
Research & Development teams
Regulatory stakeholders
Global Technical Teams
Facilitate effective communication and review of technical deliverables.
Support project milestones and strategic decision-making through scientific assessments and reporting.
Educational Qualifications
Preferred Qualifications
Master's Degree in Chemistry or Pharmacy
OR
Ph.D. in Chemistry, Pharmaceutical Sciences, or related discipline
Experience Requirements
Required Experience
5–7 years of experience in Analytical Research & Development.
Strong expertise in:
Nitrosamine workflow support
Extractables & Leachables (E&L) studies
Hands-on experience in GMP-regulated laboratories.
Instrumentation Expertise
HPLC
GC
GC-HS (Headspace GC)
LC-MS
GC-MS
ICP-MS
Additional Competencies
Analytical data interpretation
Technical report writing
Method development and validation
Investigation and troubleshooting
Technical Skills
|
Skill Area |
Proficiency Level |
|---|---|
|
LC-MS |
Advanced |
|
GC-MS |
Advanced |
|
HPLC |
Advanced |
|
GC |
Advanced |
|
Wet Chemistry |
Advanced |
|
GDP / GLP / cGMP |
Intermediate |
|
SOP Compliance |
Intermediate |
Behavioral Competencies
Leadership & Decision Making
Think Big
Speak Up
Be Decisive
Focus on What Matters
Collaboration
Agree Who Does What
Measure Outcomes
Be Inclusive
Integrity & Ownership
Act with Integrity
Take Pride in Work
Recognize and Appreciate Others
Ideal Candidate Profile
A highly skilled Analytical Scientist with 5–7 years of pharmaceutical R&D experience, possessing strong expertise in Nitrosamine analysis, Extractables & Leachables studies, LC-MS/GC-MS method development, and GMP compliance. The candidate should demonstrate excellent problem-solving abilities, technical writing skills, regulatory knowledge, and cross-functional collaboration capabilities.
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