Analytical Scientist
3 weeks ago
Qualifications & Experience:
- M.Sc. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
- 3-5 years of experience in analytical R&D within a CDMO, pharmaceutical, or biotechnology company.
Key Responsibilities:
- Develop, validate, and transfer analytical methods for raw materials, intermediates, and finished products in compliance with regulatory guidelines (ICH, USP, EP, JP, etc.).
- Perform method development using techniques such as HPLC, UPLC, GC, MS, FTIR, UV-Vis, and dissolution testing.
- Support formulation development by providing analytical data for stability, compatibility, and process optimization studies.
- Troubleshoot analytical methods and instrumentation to ensure data integrity and reliability.
- Conduct forced degradation and stability studies to establish product shelf life.
- Prepare and review technical documents, including protocols, reports, SOPs, and regulatory submissions (IND, NDA, ANDA, DMF).
- Collaborate with R&D, quality control, and regulatory teams to support drug development projects.
- Maintain compliance with GMP/GLP and other regulatory requirements during method development and validation.
- Stay updated with advancements in analytical technologies and regulatory changes to enhance laboratory capabilities.
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