Stability Associate

IntegratedResourcesINC

Waltham, MA, United States permanent

Posted: August 22, 2017

Job Description

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

Kind Regards,

Sabanaaz Shaikh

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Gold Seal JCAHO Certified ™ for Health Care Staffing

“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

Why Apply Through MisuJob?

AI-Powered Job Matching: MisuJob uses advanced artificial intelligence to analyze your skills, experience, and career goals. Our matching algorithm compares your profile against thousands of job requirements to find positions where you have the highest chance of success. This saves you hours of manual job searching and ensures you only see relevant opportunities.

One-Click Applications: Once you create your profile, applying to jobs is effortless. Your resume and cover letter are automatically tailored to highlight the most relevant experience for each position. You can apply to multiple jobs in minutes, not hours.

Career Intelligence: Beyond job matching, MisuJob provides valuable career insights. See how your skills compare to market demands, identify skill gaps to address, and understand salary benchmarks for your experience level. Make data-driven decisions about your career path.

Frequently Asked Questions

How do I apply for this position?

Click the "Register to Apply" button above to create a free MisuJob account. Once registered, you can apply with one click and track your application status in your dashboard.

Is MisuJob free for job seekers?

Yes, MisuJob is completely free for job seekers. Create your profile, get matched with jobs, and apply without any cost. We help you find your dream job without any hidden fees.

How does AI matching work?

Our AI analyzes your resume, skills, and experience to understand your professional profile. It then compares this against job requirements using natural language processing to calculate a match percentage. Higher matches mean better fit for the role.

Can I apply to jobs in other countries?

Absolutely. MisuJob features jobs from companies worldwide, including remote positions. Filter by location or look for remote opportunities to find jobs that match your preferences.

Ready to Apply?

Join thousands of job seekers using MisuJob's AI to find and apply to their dream jobs automatically.