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Senior Associate Scientist

3-6 years
Not Disclosed
10 Dec. 27, 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: GTEL, IITM-RP


Job Summary

The Senior Associate Scientist (Chem Analytical) is responsible for analytical method development, method validation, method transfer, and regulatory support. This role also involves routine analytical testing, stability studies, and investigations for APIs, intermediates, and various drug product formulations, ensuring compliance with GxP standards and safety regulations.


Role Responsibilities

Key Accountabilities

  1. Compliance & Safety

    • Perform all activities in adherence to GxP standards.
    • Ensure compliance with organizational policies, procedures, and regulatory guidelines.
    • Maintain safety compliance per EHS protocols.
  2. Analytical Development

    • Develop and validate analytical methods using UPLC, HPLC, GC, Dissolution for APIs, intermediates, drug products, and raw materials.
    • Troubleshoot analytical challenges, including methods and instrumentation.
    • Conduct assessments of existing data packages and remediation conclusions.
  3. Batch and Stability Support

    • Support analytical activities for lab trials, feasibility batches, stability batches, and stability studies per planned timelines.
    • Perform stability studies for various dosage forms and related products.
  4. Cross-Functional Coordination

    • Work with Quality Assurance and other cross-functional teams to execute LIR/ER/CAPA quality systems efficiently.
    • Coordinate across teams to meet deliverable milestones and ensure resolution of tasks within target timelines.
  5. Data Integrity and Audit Readiness

    • Ensure that all technical outputs and data packages are audit-ready and meet regulatory standards.
    • Maintain compliance with local and corporate procedures.

Qualifications & Skills

Educational Requirements

  • M.Sc. in Chemistry or M.Pharm

Experience

  • 3 to 6 years in Analytical Research and Development
  • Experience with oral solid dosage forms, liquids, semisolids, and API.

Technical Skills

  • Proficiency in HPLC, Dissolution, UV, GC, and Wet Chemistry.
  • Exceptional skills in data interpretation and delivering scientific outputs.
  • Knowledge of regulatory expectations in analytical processes.

Soft Skills

  • Strong communication and organizational skills.
  • Ability to coordinate and collaborate effectively with cross-functional teams.

Organizational Relationships

Internal Teams:

  • Small Molecule Technology
  • Global Technology & Engineering
  • Launch Excellence
  • Pfizer Manufacturing Sites
  • Regulatory Sciences
  • Global EHS

External Interactions:

  • Contract Research and Manufacturing Organizations
  • Academic Institutes

Work Location Assignment

  • On-Premise

Pfizer is an equal opportunity employer and ensures compliance with all applicable equal employment opportunity legislation. All qualified applicants will receive equal consideration without regard to age, gender, race, religion, or any other protected status.

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