Core Purpose of the Role:

This role involves method development, method validation, method transfer by using laboratory instruments like LCMS /GCMS/ HRMS. Carry out specialized testing such as Extractables and Leachables studies.

Role Accountabilities:

- 08-12 Years of experience in Extractables/Leachables screening studies using LCMS/MS, GCMS & LC-HRMS.
- Data interpretation & identification of unknown Extractable/Leachable using LC-HRMS and preferably softwares like X Caliber, Chromeleon and Compound Discoverer.
- Responsible for preparation of test procedures, development reports, technical reports, validation protocols and reports.
- Abilities in qualification, calibration and troubleshooting of analytical instruments.
- To carry out the investigations in case of deviations, OOT, OOC & OOS.
- To ensure instruments are compliant to 21 CFR Part 11 requirements, wherever applicable.
- Preparation & review of SOPs, IOPs and EOPs and provide training whenever required.
- Must have applicable knowledge in CGMP, ICH, USP and other regulatory requirements.
- Must comply with GMP, data integrity & EHSS practices.

📌 Lead Scientist - Extractable & Leachable (Bengaluru)
🏢 Syngene
📍 Bengaluru