Associate Scientist

Pay Range: $65,000-$75,000

Position Summary

We are looking for a detail-oriented and proactive Associate Scientist to join our Stability Laboratory. In this role, you will support analytical stability studies in accordance with regulatory guidelines. The ideal candidate will have hands-on experience with small molecule drug substances and drug product batch release and stability testing, along with a strong background working in a cGMP-compliant environment.

Key Responsibilities

• Perform stability testing and related tasks in a cGMP-compliant laboratory environment.
• Ensure timely and compliant generation of stability data to support client programs.
• Draft and review stability study protocols and final reports.
• Investigate out-of-specification (OOS) results, determine root causes, and support corrective action implementation.
• Evaluate laboratory data for technical accuracy and adherence to regulatory standards.
• Oversee laboratory inventory, manage environmental chambers, and maintain supporting information systems.
• Partner with clients to design suitable batch release and stability testing strategies for APIs and finished drug products.
• Stay current with relevant ICH, FDA, and EMEA guidelines for stability studies.
  
  

Qualifications

Education and Experience:

• A Bachelor’s degree in Chemistry or a closely related scientific field is required.
• A minimum of 2 years of hands-on experience in an analytical laboratory within a cGMP-regulated environment, or an equivalent combination of education and experience.
• Direct experience in a quality control or stability testing laboratory is strongly preferred.
  
  

Skills And Competencies

• Hands-on experience with standard laboratory instruments, including HPLC, analytical balances, pH meters, and more.
• Proficient in essential laboratory techniques such as assay performance, impurity testing, sample preparation, and dilutions.
• Familiar with ICH stability guidelines and their application in pharmaceutical testing.
• Experience working in GMP-compliant laboratory environments, ensuring adherence to regulatory standards and quality protocols.
  
  

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you

INDBH