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Scientist Iv / Iii, Reference Standards Evaluation

8-10 years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: M.Sc./M.Pharm/PhD 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

Scientist IV / III, Reference Standards Evaluation
Location: Hyderabad, India
Job Category: Chemistry & Scientific Standards
Job Type: Full-time
Req ID: SCIEN002630

Job Overview:

The Scientist IV/III position is a non-supervisory, hands-on role focused on managing the implementation and completion of activities within the Reference Standards (RS) and Material Strategy programs (CRM/ARM). The incumbent will be responsible for the preparation of procurement specifications, collaborative testing protocols, analytical data review, preparation of summary reports, and the development of packaging and Quality Control testing instructions.

Key Responsibilities:

  • Collaborative Testing Protocols:

    • Prepare collaborative testing protocols for new/replacement RS lots.

    • Provide technical assistance to collaborating labs.

    • Review analytical data received from collaborators and prepare summary reports.

  • Quality Control & Documentation:

    • Prepare packaging and QC testing instructions, as well as assign periodic re-test intervals.

    • Maintain scheduling operations, documents, and ensure availability of reference standards in a complex portfolio.

  • Product Planning & Coordination:

    • Draft product planning documents (PPD) and coordinate with labs.

    • Review and interpret data from international collaborative studies.

    • Coordinate additional necessary testing and assist staff in addressing comments.

  • Study Proposals & Data Interpretation:

    • Propose and design studies to obtain necessary data to resolve complaints.

    • Provide correct guidance on test data interpretation.

  • Cross-Functional Collaboration:

    • Support the Documentary Standard team by peer reviewing draft monographs.

    • Address customer technical inquiries and investigate customer complaints with minimal guidance.

    • Facilitate cross-functional activities with other departmental staff and USP staff.

  • Public Speaking & Reporting:

    • Present information regarding the Reference Standards program to USP staff and external audiences.

  • Other Duties:

    • Perform other related duties as assigned.

Qualifications:

  • Education & Experience:

    • Scientist IV: MSc/MPharm with 8-10 years of experience, or Ph.D. with 3-5 years of experience.

    • Scientist III: MSc/MPharm with 6-8 years of experience, or Ph.D. with 1-3 years of experience.

  • Skills & Expertise:

    • Ability to read and interpret spectroscopic analyses data (NMR, IR, MS, etc.).

    • Hands-on experience with chromatographic techniques (HPLC, GC).

    • Ability to handle multiple priorities in a fast-paced environment.

    • Excellent written and verbal communication skills.

Additional Desired Preferences:

  • Exposure to XRD, polymorphic studies, and stability studies.

  • Strong knowledge of spectroscopic analysis (NMR, IR, MS) and chromatographic techniques.

Benefits:

USP provides comprehensive benefits to protect your personal and financial well-being, including healthcare options, company-paid time off, and retirement savings.