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Scientist Ii, Cdl

2+ years
Not Disclosed
10 Dec. 19, 2024
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-II - Compendial Development Laboratory (CDL)
Location: India

About USP:
The United States Pharmacopeia (USP) is committed to improving global health by advancing public health standards, ensuring access to safe, high-quality medicine. We focus on equitable health solutions through collaboration and innovation. At USP, we invest in our people’s development, ensuring a diverse, inclusive, and engaging work environment.

Role Overview:
This non-supervisory position in the Compendial Development Laboratory (CDL) within Global Laboratory Operations is responsible for analytical method development and validation for USP/NF monographs. The role also involves maintaining safety standards and ensuring a GLP-compliant environment. You will contribute to USP’s mission to enhance public health and support monograph modernization initiatives.

Key Responsibilities:

  • Plan, execute, and validate methods for small molecule projects as per USP general chapters, guidelines, SOPs, and protocols.
  • Develop and validate analytical methods, including the use of instruments such as HPLC, FT-IR, and UV-Visible.
  • Prepare project plans, reports, and laboratory data as per requirements.
  • Maintain adherence to GLP and safety practices in the laboratory.
  • Engage in continuous professional development through practices in diversity, equity, inclusion, and belonging.

Candidate Profile:

  • Education: Master’s degree in Chemistry or Pharmaceutical Sciences.
  • Experience: 3-6 years of hands-on experience in analytical method development and validation.
  • Technical Skills:
    • Proficient in working with chemical methods and instruments like HPLC, FT-IR, UV-Visible, GC, ICP-OES/MS, AAS, and KF.
    • Solid understanding of USP/NF monographs and GLP regulations.
    • Experience with GMP/GLP/QMS environment and data integrity.
    • Ability to interpret technical information and contribute to technical writing and oral communication.
    • Familiarity with ISO/IEC 17025 is a plus.

Desired Skills and Experience:

  • Experience in drug substance, drug products, and various dosage forms.
  • Exposure to regulatory audits and technical writing experience.
  • Strong communication and diplomatic skills with the ability to build credibility with stakeholders.

Benefits:
USP offers a range of benefits designed to protect your personal and financial well-being, including company-paid time off, comprehensive healthcare options, and retirement savings plans.

Note:
USP does not accept unsolicited resumes from third-party recruitment agencies unless under a specific written agreement.