Stability Associate

Title: Stability Associate
Duration: 6 Months (Temp to perm)
Location: Waltham, MA. 02451
Position Summary:

• Support operational and technical aspects of clinical/commercial drug substance, drug product, reference standard, and placebo GMP stability programs.
• Ensure compliance and support of company Standards, Practices, and SOPs as well as ICH and FDA guidelines.
• This includes design of stability protocols, expiry dating for clinical/commercial products, providing stability sections for regulatory submissions, technical assessment of stability data, specification changes and investigations, routinely working with CMO/CLOs to ensure timelines are met for release and stability testing of product.

Key Responsibilities:

• Designs and manages studies. Collaborates with CLOs to ensure proper testing and reporting of stability samples.
• Assigns expiry to drug substance, drug product, and reference standard
• Trends and evaluates stability data proactively.
• Authors’ stability reports for regulatory submissions.
• Participates in meetings and contributes toward the goals of the CMC. Contributes to major/critical manufacturing and leads stability investigations (deviations, OOS, cross-site and cross-functional).
• Authors stability assessments writing for basic Anomalous Results (ARs) and Out of Trend (OOT) stability results.

Minimum Qualifications:

• BS or MS degree in science (Analytical Chemistry, Biochemistry, Biology, Chemistry, Organic Chemistry, Pharmaceutical Chemistry, Protein Chemistry) or related technical field.
• Minimum 2 years of direct experience in stability/ formulation of biological and/or small molecule products in the Pharmaceutical industry, with 5-8 years industry experience.

Skills Required:

• Knowledge of analytical methods, ICH Guidelines, and strong ability to analyze data.
• Good understanding of statistical analysis and interpretation of data.
• Proficiency with cGMPs and experience with Microsoft Office (Word, Excel, and PowerPoint) and SAS JMP are required.
• Strong technical writing skills and communication skills are essential

Kind Regards,
Sabanaaz Shaikh
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
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