Analytical Scientist at Azurity Pharmaceuticals

About Azurity Pharmaceuticals

Azurity Pharmaceuticals is a privately owned company specializing in developing innovative pharmaceutical products aimed at underserved patient populations. It leads the industry by offering unique, accessible, and high-quality medications across various therapeutic areas including cardiovascular, neurology, endocrinology, gastrointestinal, institutional, and orphan markets. The company attributes its success to a talented and dedicated workforce committed to science and quality.

Role Overview

This position is within the R&D Analytical team that plays a critical part in developing various dosage forms. The team's focus includes analytical method development, stability studies, method verifications with contract manufacturing organizations and testing laboratories, and activities after product filling.

Key Responsibilities

• Adhere strictly to good documentation practices (GDP).
• Develop analytical methods targeting Nitrosamine impurities utilizing advanced instrumentation and validate methods according to protocol.
• Develop methods to identify unknown and genotoxic impurities using HPLC-PDA/UV/ELSD and LCMS technologies.
• Ensure the accuracy, completeness, and adequacy of all documentation and data generated during analytical work.
• Analyze formulation development samples according to analytical test requests, document findings online, and complete analyses within stipulated timelines.
• Comply with Good Laboratory Practices (GLP), maintain data integrity and conform to Standard Operating Procedures (SOPs).
• Develop analytical methods using various techniques, verify compendial and drug substance test methods.
• Follow laboratory safety procedures diligently.
• Prepare stability test protocols (STP), master data records (MDR), and method of analysis (MOA) documents as applicable.

Qualification and Experience Requirements

• Postgraduate degree in Pharmacy or Science.
• At least three years’ experience in pharmaceutical analytical R&D with significant experience handling LCMS instruments.
• Expertise in developing analytical methods for Nitrosamine impurities in drug substances, drug products, and excipients.
• Knowledge and experience in identification of unknown impurities using LCMS in pharmaceutical research and development.
• Understanding and application of Good Laboratory Practices and Good Documentation Practices.
• Familiarity with electronic laboratory notebook (eLN) and document management systems (DMS).
• Proficient in both written and spoken English.

Additional Information

Applicants should confirm they are mentally and physically able to perform the job duties as described without limitations. Any concerns or disabilities that may affect job performance should be disclosed to Human Resources prior to application.