Senior Scientist, Analytical R&D

Overview

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.

• 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 transfer activities for raw materials and finished dosage forms.
• Ensures compliance with SOPs, policies and procedures required by the Company and regulatory agencies.
• Document experiments accurately and complete all associated documents (Instrument, Standard and Column usage logbooks) in compliance with internal SOPs and FDA guidelines.
• Evaluate test results against standards and timely reporting of any deviations, OOS, OOT and atypical results to the supervisor/department head.
• Other duties assigned by management based on requirements.
• Management Responsibility:
  Assign daily work schedule in timely manner;
  Provide Suggestions in method Development and validation;
  Interpret and review generated results;
  Provide assistance in professional development.
• Report to:
  Manager Analytical R&D

• Hands-on experience in Dissolution, HPLC, LC-MSGC, UV, FTIR, and other laboratory instruments.
• Experience with a wide variety of software and information systems (e.g. Empower, Microsoft Word and Excel).
• Strong knowledge in analytical method development and validation under cGMP environment and experience in problem-solving skills and instrument troubleshooting.
• Good oral and written communication skills and the ability to write and review technical report.
• Proven Knowledge of the major analytical techniques and operation of instruments such as HPLC, GC, dissolution, FT-IR, UV-VIS Spectrophotometer, Particle size analysis (Malvern Mastersizer, Sonic sifting and Sieve shaker), Karl Fischer Instrument, Potentiometric Titration, Density meter, pH meter, Melting point apparatus, Analytical Balances, Viscometer.
• Proficient in documentation as per Good Documentation Practice.
• Computer skills including Microsoft and Excel.
• Excellent verbal and written communication skills.

• Bachelor's degree in Analytical Chemistry or Chemistry or related field with 4+ years or MS/PhD with 2+ years of GMP and GLP-related pharmaceutical industry experience in Peptide and small molecule solid oral formulation analytical development.
• Knowledge of Good Manufacturing Practices (cGMP).
• Experience with software and information systems (e.g. Empower, Microsoft Word and Excel).
• Physical requirements/Working Environment:
  Must be able to stand for long periods of time (up to 12-hour shifts), maneuver at least 40 pounds, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE.
• Vision - ability to see details at close range.

The above…