Orbit Pharma
Delivering Excellence

Analytical Development Department

Minimum qualifications

  • Master’s degree in analytical science.
  • Bachelor’s and master’s degrees in the pharmacy.
  • 1-3 years of relevant experience in analytical method development and validation.

Roles and Responsibilities

  • Execute routine Analytical Research activities on drug products.
  • Troubleshooting related to Testing methods, Stability studies, test results, and designing of additional experimentations as necessary.
  • Execution of Analytical Method validation activities for drug products as per the regulatory requirements.
  • To conduct the API characterization and compatibility study for the formulation.
  • Execution & coordination for Analytical method transfer activities of drug products.

  • Preparation and review of Specifications, Method of analysis procedures, and Analytical development reports.

  • Preparation and review of analytical protocols and reports (Analytical method validation, Method feasibility, Analytical method transfer, etc.).
  • Assisting and resolving technical queries raised during Technology transfer activities & regulatory submissions.
  • Assisting in the establishment of In-house Infrastructure (Analytical equipments Qualifications and preparation of SOP’s)
  • Coordination with cross-functional departments.
  • Handling of general laboratory instruments and equipments like HPLC, UV, GC, Dissolution, etc.
  • Maintenance of laboratory chemicals and consumables.
  • Troubleshooting of instruments in case of problems.
  • Literature search.
  • Documentation and data control.

Skills / Abilities

  • Hands-on experience with HPLC, GC, and other routine laboratory instruments.
  • Excellent computer skills, including Word and Excel and the relevant instruments software handling.
  • Excellent interpersonal skills.
  • Must have the ability to work under pressure, meet deadlines, and work on multiple projects simultaneously
  • Experience in a regulated market is strongly preferred.
  • Must have the ability to work independently.