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Senior Associate Scientist

3-6 years
Not Disclosed
10 Dec. 26, 2024
Job Description
Job Type: Full Time Education: MSc./M. Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Department Name: AT-GTEL, Chennai
Job Title: Senior Associate Scientist (Chem Analytical)

Global Job Levels

  • Job Family Group: Research and Development
  • Job Family: 093 - Chemistry-Analytical
  • Job Category: Research
  • Job Level: R02 - Senior Associate Scientist
  • Job Code: 602689
  • Management Level: J050

Reports To: Group Lead
Location(s): GTEL, IITM-RP


Job Summary

The Senior Associate Scientist is responsible for analytical method development, validation, transfer, and troubleshooting. Key responsibilities include regulatory support, stability studies, and ensuring quality compliance for APIs, intermediates, and drug product formulations.


Role Responsibilities

Compliance and Safety

  • Perform all activities adhering to GxP standards.
  • Maintain compliance with quality and safety standards as per organizational policies and regulatory guidelines.

Analytical Responsibilities

  • Troubleshoot analytical challenges related to methods and instruments.
  • Develop and validate analytical methods for UPLC, HPLC, GC, dissolution, and wet chemistry for APIs, drug products, intermediates, and raw materials.
  • Conduct stability studies, including lab trials, feasibility batches, and lab-scale batches.
  • Perform assessments and remediation of existing data packages.

Technical Support

  • Ensure all technical outputs comply with global training standards for instrument operations, material handling, and certifications.
  • Collaborate with Quality Assurance and cross-functional teams to support investigations (LIR/ER/CAPA) and ensure task completeness.
  • Ensure data packages are audit-ready and meet compliance standards.

Coordination and Execution

  • Work with cross-functional teams to meet deliverable milestones on time.
  • Maintain disciplined execution of quality systems and consistent technical documentation.

Qualifications and Skills

Education:

  • M.Sc. in Chemistry or M.Pharm.

Experience:

  • 3–6 years in Analytical Research and Development.
  • Knowledge of oral solid dosage forms, liquids, semisolids, and APIs.
  • Familiarity with regulatory expectations and proficiency in data interpretation and scientific reporting.

Technical Expertise:

  • Hands-on experience with HPLC, dissolution, UV, GC, and wet chemistry methods.

Preferred Skills:

  • Strong understanding of regulatory guidelines and analytical methodologies.
  • Proficiency in handling complex analytical challenges and ensuring high-quality deliverables.

Organizational Relationships

  • Internal Teams: Small Molecule Technology, Global Technology & Engineering, Launch Excellence, Pfizer Manufacturing Sites, Global Supply Chain, Regulatory Sciences.
  • External Interactions: External supply partners, contract research organizations, and academic institutes.

Work Location Assignment

On Premise

Pfizer is an equal opportunity employer and complies with applicable equal employment opportunity legislation globally.

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Research and Development