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Scientist

6-10 years
Not Disclosed
10 Dec. 27, 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 Title: Analytical Development Scientist
Location: On-Premise
Company: Pfizer


Job Summary

The Analytical Development Scientist is responsible for method development, validation, transfer, and investigation using a DMAIC approach. This role includes providing support for regulatory submissions, stability studies, and routine analytical testing for APIs, intermediates, and various drug product formulations. The position requires technical training, stakeholder management, and troubleshooting to ensure compliance with safety and quality standards.


Key Responsibilities

Primary Accountabilities

  • Analytical Methodology: Perform method development, validation, transfer, investigation, and regulatory support for API qualification, characterization, and reaction monitoring.
  • Compliance & Safety: Ensure adherence to cGMP/GSP, organizational procedures, and safety protocols, targeting zero safety incidents in laboratory areas.
  • Stakeholder Engagement: Build relationships with customers and stakeholders to ensure successful project outcomes and alignment across the product value stream.
  • Investigation & Troubleshooting: Conduct investigations for OOS/OOT failures using DMAIC tools and provide solutions to ensure timely resolution.
  • Stability Studies: Plan and execute stability studies for development batch samples, including temperature excursions and freeze-thaw studies.

Secondary Responsibilities

  • Documentation: Prepare and review scientific protocols, reports, and analytical data in eLN and other required formats.
  • Training & Supervision: Provide technical training to junior scientists and review their electronic notebooks and analytical data.
  • Technology Advancement: Stay updated with newer technologies and ensure their application in projects for efficiency and quality improvement.
  • Procurement: Source standards and impurities, ensuring proper verification of characterization data.
  • Collaboration: Work with cross-functional teams and global networks, including regulatory sciences, EHS, manufacturing sites, and external vendors.

Qualifications & Skills

Education

  • MSc/MPharm/Ph.D. in Chemistry or Analytical Chemistry.

Experience

  • 6 to 10 years in Analytical Development, Method Validation, Impurity Isolation & Characterization, and Lifecycle Management.
  • Strong background in drug substance and drug product analytical development with expertise in analytical research.

Technical Skills

  • Proficiency in wet chemistry, HPLC, GC, mass spectroscopy, FTIR, UV/Vis, dissolution, and understanding of regulatory requirements.
  • Expertise in user-friendly analytical methods with a focus on ensuring timely batch release without bottlenecks.

Soft Skills

  • Strong communication and listening skills.
  • Ability to manage complex investigations and maintain collaborative relationships with internal and external stakeholders.

Key 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
  • External Vendors and Supply Chains

Work Location Assignment

  • On-Premise

Pfizer is committed to creating a diverse environment and is proud to be an equal-opportunity employer. All qualified applicants will receive consideration without regard to age, race, religion, gender, sexual orientation, or any other protected status.

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