Senior Scientist, Analytical R&D

Job Summary:

Granules Pharmaceuticals, Inc., is seeking a detail-oriented and scientifically driven Sr. Scientist to join our team in the area of Analytical Method Development and Validation. The ideal candidate will possess strong expertise in developing and validating analytical methods for assay, related compounds, residual solvents, dissolution, and particle size analysis. Proficiency in Mass Spectroscopy and peptide testing is essential, with experience in bioassay methodologies considered a plus. This role requires a solid understanding of scientific principles to troubleshoot and solve analytical challenges, as well as experience in drafting and reviewing method validation protocols and reports in compliance with SOPs and regulatory guidelines. Strong communication skills and the ability to interpret technical procedures, FDA guidance documents, and scientific literature are essential for success in this role.

JOB DUTIES & RESPONSIBILITIES include but not limited to:

•  With minimal supervision, perform the analytical method development and method validation for dissolution, assay, and related compounds of raw material and finished products.
• Develops and validates methods to determine purity, potency, identity, residuals, and characterization of peptide products.
•  Ability to individually work on development and validation for Reversed-Phase, Ion Exchange, and Size Exclusion chromatography using UPLC/HPLC/MS.
• Draft the analytical method validation protocols and reports
• Performs testing pharmaceutical raw materials, bulk and finished products, scale-up samples, process validation samples, cleaning verification/validation samples, and stability samples to support formulation development.
• Responsible for the timely and accurate execution of lab analysis.
• Independently compile the analytical data, make sound judgment of the data and interpret the data, and notify the results to manager/Director.
• Maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs.
•  Maintain laboratory notebooks and records of all the raw data as per Good Documentation Practices.
• Assists with training other junior members of the analytical development team as needed
• Maintain individual training records.
• Follow safety procedures and practices.
• Maintain a clean, orderly work environment.
• Works with computer-controlled equipment and processes.
• Performs other work-related duties as assigned
• Perform in-vitro dissolution testing for in-process, finished product and stability samples.
• Execute method