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Research Scientist

0-3 years
Not Disclosed
10 March 6, 2025
Job Description
Job Type: Full Time Education: MS/M.Sc 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

Research Scientist

Company: Orbit Pharmaceuticals
Location: Ahmedabad
Experience: 0 - 3 years
Salary: 1-2 Lacs P.A.
Openings: 1

Job Description:

Key Responsibilities:

  • Conduct literature searches and prepare literature reports.
  • Develop and optimize analytical methods for drug products based on QbD principles and regulatory requirements.
  • Execute routine analytical research activities, including drug product analysis and stability sample testing.
  • Operate and maintain analytical instruments such as HPLC, UV, IR, Dissolution, and GC.
  • Review and evaluate experiments and analytical data.
  • Interpret, record, and maintain data as per regulatory requirements.
  • Troubleshoot testing methods, stability studies, and test result discrepancies while designing additional experiments when necessary.
  • Conduct pre-formulation studies, solubility studies, forced degradation studies, reverse engineering studies, and reference product characterization.
  • Prepare and review specifications, methods of analysis, and analytical development reports.
  • Prepare and review analytical protocols and reports for method validation, feasibility, and method transfer.
  • Execute analytical method validation activities for drug products as per regulatory requirements.
  • Address queries received from regulatory agencies.

Qualifications:

  • Education: B. Pharmacy / M. Pharmacy / M.Sc. in Analytical Chemistry.

Desired Skills:

  • Strong conceptual knowledge in analytical method development and validation.
  • Ability to manage multiple projects within deadlines.
  • Hands-on experience with various analytical methods and instrumentation.
  • Knowledge of QbD, DoE, and statistical interpretation.
  • Effective collaboration and teamwork skills.

Role: Research Scientist
Industry: Pharmaceutical & Life Sciences
Department: Research & Development
Employment Type: Full Time, Permanent
Role Category: Pharmaceutical & Biotechnology