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Scientist I, Analytical Research & Development

1-3 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 I, Analytical Research & Development
Location: Hyderabad, India
Job Category: Chemistry & Scientific Standards
Job Type: Full-time
Req ID: SCIEN002751

Job Overview:

The Scientist I in Analytical Research & Development (AR&D) will support the development of reference materials. The role involves working on analytical method development for in-process samples in synthetic labs, conducting various non-routine and routine analytical tests, ensuring compliance with GLP standards, and contributing to the evaluation of reference standards, method validation, stability studies, and research projects.

Key Responsibilities:

  • 60% Support for Reaction Monitoring and Scale-Up: Assist in the analysis of samples as per monograph/in-house procedures, including method development as required. Prepare development reports for synthetic support projects and ensure the projects are executed as per the approved test protocols.

  • 15% Equipment and Inventory Management: Execute IQ/OQ/PQ for new instruments, manage procurement of lab materials, and maintain GLP and safety procedures.

  • 10% Documentation and SOP Preparation: Prepare SOPs, protocols, and reports. Coordinate with the Purchasing department and ensure the calibration of equipment is conducted according to schedule.

  • 10% ISO-9001 Certification Support: Participate in ISO-9001 certification and recertification processes, handle internal and external QA audits, and address audit findings.

  • 5% Diversity, Equity, Inclusion, and Belonging: Adhere to DEI principles at USP India.

Qualifications:

  • Education: MSc. in Analytical Chemistry, Organic Chemistry, or M. Pharma, with 1-3 years of experience in Analytical Research and Development.

  • Experience: Hands-on experience in chemical methods and using instruments such as HPLC, FTIR, UV-Visible, and wet chemistry. Exposure to GMP/GLP environments and documentation procedures is required.

  • Skills:

    • Ability to perform analytical method development.

    • Excellent technical writing and verbal communication skills.

    • Familiarity with GC, ELN, Empower, and NuGenesis is preferred.

    • Strong interpersonal skills and the ability to work in a team-oriented environment.

Benefits:

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