Stability Associate — GMP & Regulatory Submissions

Integrated Resources Inc.; Waltham (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading staffing firm is seeking a Stability Associate for a 6-month temporary role in Waltham, MA. The position involves managing GMP stability programs, ensuring compliance with ICH and FDA guidelines, and authoring stability reports. A BS or MS in science and at least 2 years of related experience in the pharmaceutical industry are required. Strong analytical and communication skills are essential, along with proficiency in Microsoft Office and SAS JMP.

Qualifications

• 2 years of experience in stability/formulation of biological or small molecule products.
• Strong ability to analyze data and understanding of ICH Guidelines.

Responsibilities

• Manage studies and collaborate on stability samples.
• Ensure compliance with company standards and regulations.
• Author stability reports for regulatory submissions.

Skills

Knowledge of analytical methods

Statistical analysis

Proficiency with cGMPs

Technical writing skills

Data analysis

Education

BS or MS degree in science

Tools

Microsoft Office (Word, Excel, PowerPoint)

SAS JMP

Job description

A leading staffing firm is seeking a Stability Associate for a 6-month temporary role in Waltham, MA. The position involves managing GMP stability programs, ensuring compliance with ICH and FDA guidelines, and authoring stability reports. A BS or MS in science and at least 2 years of related experience in the pharmaceutical industry are required. Strong analytical and communication skills are essential, along with proficiency in Microsoft Office and SAS JMP.