Scientist IV, Analytical Research & Development

About This Role

This non-supervisory position supports the process development and scale-up of Active Pharmaceutical Ingredients (API) and related materials. The role involves analytical method development and evaluation for in-process samples in synthetic chemistry, performing routine and non-routine analytical tests, and maintaining a safety and GLP environment in the lab. It suits a scientist who can direct, troubleshoot, and share insights on complex projects, draw independent conclusions, and collaborate closely with other scientists.

Responsibilities

• Support reaction monitoring, scale-up, and final analysis of samples as per monograph/in-house procedures, including method development/validation if required
• Prepare development reports for Synthetic Support projects
• Execute projects per approved test protocols if assigned
• Plan, execute, and complete projects as per specifications, timelines, and budget
• Prepare and review SOPs, protocols, and reports
• Ensure project requirements by coordinating with external vendors and all internal relevant departments
• Ensure the required maintenance and calibrations of equipment
• Prepare, execute, and complete IQ/OQ/PQ of new instruments as assigned
• Prepare and plan for ISO-9001 certification/recertification by participating actively, verifying protocols and related documents, and taking an active role in internal and external QA audits, addressing audit issues in a timely manner
• Maintain GLP and implement safety procedures while working in the Lab
• Work on any other assigned tasks/lab management activities
• Be conversant with lab safety norms and strictly follow them
• Collaborate within the team and cross-functional teams
• Learn and practice Diversity, Equity, Inclusion & Belonging culture

Requirements

• M.Sc. in Analytical Chemistry / Organic Chemistry/M. Pharm with 8-10 years of experience in Analytical Research and Development, or Ph.D. with 4-7 years of experience in Analytical Research and Development
• Hands-on experience working with chemical methods and handling instruments like HPLC, GC, LC-MS, GC-MS, FTIR, UV-Visible, wet chemistry, etc.
• Experience in analytical testing and development with a focus on process analytical chemistry to understand, monitor, and control chemical processes/reactions
• A comprehensive understanding of the science involved in the development of synthetic organic molecules and analytical chemistry
• Ability to perform analytical method developments and method validations as and when required
• Excellent technical writing and verbal communication skills
• Good interpersonal skills and proven ability to function in a team-oriented environment