Research Scientist I - E&L
On-siteBengaluru, Karnataka, India
EXPIREDBengaluru, Karnataka, IndiaOn-siteFull TimeDoctorate Or Professional DegreeLarge
Full TimeDoctorate Or Professional DegreeLarge
Job Summary
Develop and qualify state-of-the-art methods using LCMS, GCMS, and HRMS for extractable and leachable studies of medical devices and drug products. Strategize and design E&L studies while reviewing complex analytical data to draw interpretations and conclusions on unknown compounds. Collaborate with multidisciplinary teams to develop trace analysis strategies, execute laboratory studies at in-house and external CRO facilities, and author reports for internal documentation and regulatory submissions. Lead change control impact assessments to ensure safety and compliance across Renal and Acute Care businesses.
Required Qualifications
- Ph.D. / Post graduate degree (M Pharm, MSc, MS) in scientific discipline (Pharmaceutical, Analytical or Organic chemistry preferred)
- minimum of 10 years of relevant (E&L, Mass spec) experience
- Demonstrated experience & expertise in Extractables & Leachable
- hands-on experience in mass spectrometry (HRMS, LCMS and GCMS)
- study design for medical devices and drug products
- Knowledge of regulatory expectations related to trace analysis for drugs and devices
- Performing change control in a GMP environment
- Experience of working in global cross-functional teams for trace analysis projects
- Independent problem solver who can use a methodical approach to develop solutions and make recommendations
Desired Qualifications
- Pharmaceutical, Analytical or Organic chemistry preferred
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.