Stability Program Specialist

2 weeks ago


Waltham, Massachusetts, United States Integrated Resources Full time
Company Overview:
Integrated Resources, Inc is a leading staffing agency known for its exceptional service and integrity in the professional specialty field since 1996. Our focus is on providing top-tier talent consistently across various sectors.

Job Title:
Stability Associate

Position Summary:
The Stability Associate will play a crucial role in supporting the operational and technical facets of GMP stability programs for clinical and commercial drug substances, products, reference standards, and placebos. This position requires adherence to company standards, practices, and SOPs, along with compliance with ICH and FDA regulations.

Key Responsibilities:
1. Design and manage stability studies, ensuring collaboration with Contract Laboratories to facilitate accurate testing and reporting of stability samples.
2. Assign expiry dates for drug substances, products, and reference standards.
3. Proactively trend and evaluate stability data.
4. Author stability reports for regulatory submissions.
5. Participate in cross-functional meetings, contributing to the goals of the CMC team.
6. Lead stability investigations, addressing deviations and Out of Specification (OOS) results.
7. Document stability assessments for Anomalous Results (ARs) and Out of Trend (OOT) stability results.

Qualifications:
- A BS or MS degree in a scientific discipline such as Analytical Chemistry, Biochemistry, Biology, Chemistry, Organic Chemistry, Pharmaceutical Chemistry, or Protein Chemistry.
- A minimum of 2 years of direct experience in stability and formulation of biological and/or small molecule products within the pharmaceutical sector, complemented by 5-8 years of overall industry experience.

Required Skills:
- Proficient knowledge of analytical methodologies and ICH Guidelines, with a strong capability to analyze data.
- Solid understanding of statistical analysis and data interpretation.
- Familiarity with cGMP regulations and proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and SAS JMP.
- Excellent technical writing and communication skills are essential for success in this role.

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