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Scientist

6-10 years
Not Disclosed
10 Dec. 26, 2024
Job Description
Job Type: Full Time Education: MSc/M Pharm/Ph.D 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

Job Summary
The Analytical Scientist is responsible for performing method development, validation, transfer, and investigation using the DMAIC approach. This includes providing regulatory support, analytical testing for API and formulations, conducting stability studies, and troubleshooting. The role also entails mentoring junior scientists, implementing technical training, and managing stakeholder relationships with minimal to no supervision.


Key Responsibilities

Method Development and Validation

  • Conduct method development, validation, and transfer for API, intermediates, and drug product formulations.
  • Provide analytical support for regulatory submissions and method remediation.
  • Support API qualification and reaction monitoring under safety and quality compliance.

Technical Support and Investigations

  • Investigate testing failures (OOS/OOT) using Six Sigma DMAIC tools.
  • Support technical troubleshooting and stakeholder management for global network sites.
  • Prepare and review protocols, reports, and e-notebooks.
  • Participate in technology evaluations and implement new technologies.

Stability and Compliance

  • Plan and execute stability study programs for development batches.
  • Conduct temperature excursion and freeze-thaw studies.
  • Ensure compliance with cGMP/GSP practices and safety systems.
  • Strive for zero safety incidents in laboratories and working areas.

Mentorship and Collaboration

  • Mentor junior scientists and ensure effective knowledge transfer.
  • Collaborate with cross-functional teams, including Global Technology & Engineering, Regulatory Sciences, and Supply Chain teams.
  • Interact with external partners, such as CDMOs and academic institutes.

Qualifications & Skills

  • Education: MSc/M Pharm/Ph.D. in Chemistry, Analytical Chemistry, or a related field.
  • Experience: 6–10 years in Analytical Development with expertise in method validation, impurity isolation, and technology transfer.
  • Strong background in drug substance/product analytical R&D with knowledge of organic chemistry and hyphenated techniques.

Technical Proficiency:

  • Expertise in analytical techniques like HPLC, GC, Mass Spectroscopy, FTIR, UV/Vis, and wet chemistry methods.
  • Knowledge of regulatory requirements for analytical methods and processes.

Soft Skills:

  • Excellent communication and organizational skills.
  • Ability to build relationships with stakeholders and customers.

Organizational Interactions
Regular collaboration with the following groups:

  • Small Molecule Technology
  • Global Technology & Engineering
  • Launch Excellence Teams
  • Regulatory Sciences
  • Global Supply Chain
  • Pfizer Manufacturing Sites and External Supply Partners

Work Location

  • On-Premise

Pfizer is an equal opportunity employer and adheres to applicable equal employment legislation globally.

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