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Scientist Iv/Sceintist Iii , Compendial Development Laboratory

0-2 years
Not Disclosed
10 Feb. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: Scientist IV/III, Compendial Development Laboratory
Location: Hyderabad, India
Job Category: Chemistry & Scientific Standards
Job Type: Full-Time
Requisition ID: SCIEN002656


Brief Job Overview:

This is a non-supervisory role in the Compendial Development Laboratory (CDL) within Global Laboratory Operations. The role involves analytical method development and validation for USP/NF monographs and maintaining safety and a GLP environment. The incumbent will support monograph modernization initiatives to improve global public health.


Responsibilities:

  • Project Planning & Execution:

    • Engage in project planning, execution, and validation of methods according to USP general chapters, guidelines, SOPs, and protocols.

    • Apply technical expertise in analytical method development and validation for pharmaceutical products.

  • Documentation & Compliance:

    • Prepare and review project plans, reports, laboratory notebooks, and data using the Laboratory Management System (LMS).

    • Ensure adherence to GLP and safety practices in the lab.

  • Diversity, Equity, and Inclusion:

    • Practice Diversity, Equity, Inclusion, and Belonging principles at USP India.


Qualifications:

  • For Scientist-III:

    • Master’s Degree in Chemistry (Analytical/Organic) or Pharmaceutical Sciences with 6-8 years of experience or a Ph.D. with 1-3 years of experience.

  • For Scientist-IV:

    • Master’s Degree in Chemistry (Analytical/Organic) or Pharmaceutical Sciences with 8-10 years of experience or a Ph.D. with 4-7 years of experience.

  • Skills & Experience:

    • Strong understanding of USP/NF monographs, general chapters, and general notices.

    • Experience in analytical method development and validation using techniques such as HPLC and GC.

    • Hands-on experience with GPC-RI, SEC-MALS, UHPLC, LC-MS, GC-MS, FTIR, KF, and UV-Visible instruments.

    • Familiarity with GMP/GLP environments and documentation procedures.

    • Knowledge of ISO/IEC 17025 is desirable.

  • Additional Skills:

    • Strong technical writing and oral communication skills.

    • Ability to interpret technical information and communicate effectively.

    • Exposure to external regulatory audits and a good understanding of GLP regulations.


Benefits

USP offers benefits to support the well-being of employees and their families, including company-paid time off, healthcare options, and retirement savings.


Who is USP?

USP (United States Pharmacopeial Convention) is a scientific organization that collaborates with global health authorities to create standards for medicines, dietary supplements, and food ingredients. USP aims to improve access to high-quality, safe medicines and healthcare.