Candidate required for the role of Analytical scientist in Analytical development lab – RM/PM team to support API evaluation.

Position / Job Title - Executive/Sr Executive

Department - Analytical Department – RM/PM team

Reporting To- Manager

Location- Thane

Years of Experience - 5-10 yrs

Dosage Form - NA

Job Responsibilities / Deliverables

- Perform analysis of API samples for Assay, RS, Residual solvents, particle size distribution, Identification, water content using HPLC, GC, Malvern Mastersizer,etc.
- Perform method development, method validation/verification for API.
- Review DMF and evaluate methods reported by API manufacturer.
- Perform calibration of equipment/instruments as per schedule.
- Coordinate with QC and R&D; teams and work independently to meet timelines
- Ensure compliance with ICH, GMP, GLP, and data integrity requirements




- Follow the system / operational SOP’s.
- Ensure data integrity and accuracy of supporting data
- Perform method transfer activity at different sites.
- Handle change process and QMS activities as required.

Qualifications & Pre-requisites

- M.Sc. in Analytical Chemistry or Organic Chemistry
- Hands-on experience with HPLC, GC, UV, IR, TOC, IC, KF, Particle Size Analyzer
- Sound knowledge of USP, Ph. Eur., IP, BP analytical methods for APIs and excipients

Additional notes
- Role is expected to work in all shifts and based on the business requirement, need to travel to plants for analysis and document related activities.

📌 Senior Executive (Thane)
🏢 Rubicon Research
📍 Thane