Pfizer Hiring Scientist Chem Analytical -apply online

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2 weeks ago

Pfizer Hiring Scientist Chem Analytical -apply online

Role Title: Scientist (Chem Analytical)
Location: AT-GTEL, Chennai

Job Overview

Global Job Levels:

Job Family Group: Research and Development
Job Family: 093 – Chemistry-Analytical
Job Category: Research
Job Level: R03 – Scientist
Job Code: 602741
Management Level: J060 (06C)

Why Patients Need You

At Pfizer, our mission is to revolutionize healthcare by delivering breakthroughs that significantly impact patients’ lives. The Research and Development team forms the backbone of this mission, advancing cutting-edge science and technologies to create transformative therapies and vaccines. As a part of this team, you will contribute to innovations that enhance drug efficacy and safety while accelerating the path to the marketplace. Your role will directly influence our ability to provide life-saving medicines to patients worldwide.

Accountabilities and Responsibilities

As a Scientist specializing in Chemical Analytical processes, you will focus on Extractables and Leachables (E&L) testing for a variety of pharmaceutical matrices, ranging from simple aqueous solutions to complex formulations. Your responsibilities include:

Key Analytical Responsibilities:

Support for E&L Workflow:
- Analytical method development and validation.
- Investigation of extractables and leachables.
- Toxicological assessments.
- Regulatory compliance and documentation.
Primary and Secondary Packaging Testing:
- Analyze packaging materials such as bottles, tubes, syringes, transdermal patches, and storage bags.
- Evaluate single-use systems and process materials used during biopharmaceutical manufacturing.
Methodologies and Studies:
- Conduct leachable method development and validation.
- Perform leachable studies on stability samples.
- Undertake migration and simulated-use studies.
- Perform shelf-life studies in compliance with GMP/cGMP requirements.
Regulatory and Compliance Standards:
- Ensure adherence to standards such as USP, Ph.Eur, JP, ICH Q3A/Q3B/Q3C/Q3D, EMA, FDA, and others.
- Conduct assessments following PQRI recommendations for extractables and leachables.

Technical Proficiency Required

Analytical Techniques Expertise:

Chromatography: GC/MS, HS-GC/MS, PTV-GC/MS, HPLC-UV/MS, LC/MS/MS.
Spectroscopy: FTIR, UV/VIS, and high-resolution mass spectrometry.
Plasma and Ion Analysis: ICP-OES, ICP-MS, and Ion Chromatography.
Basic Analytical Tools: Total Organic Carbon (TOC), pH, conductivity measurements.
Advanced Structural Elucidation: Fraction collection by HPLC and NMR analysis (desirable).

Toxicological Assessments:

Derive health-based thresholds like PDE values.
Conduct in silico toxicological assessments (e.g., QSAR tools).
Evaluate substances under ICH-M7, ICH S9, and ISO 10993-17 frameworks.

Regulatory Collaboration:

Coordinate with quality assurance teams to align with GxP practices.
Ensure readiness for audits and compliance with data integrity standards.

Preferred Qualifications

Educational Requirements: MSc/MPharm/Ph.D. in Analytical Chemistry, Pharmaceutical Chemistry, or a related field.
Experience: 9 to 12 years in:
- Developing analytical strategies in drug and process development.
- Working in a regulated environment under Good Laboratory Practices (GLP).
- Interdisciplinary collaboration with teams in small molecule technology, regulatory sciences, and global manufacturing.
Key Skills:
- Expertise in analytical verification and method development.
- Knowledge of industry standards, regulatory guidance, and product development processes.
- Strong verbal and written communication skills.