Stability Associate

Stability Associate

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

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