Scientific and Clinical Careers

Job Title

Scientific & Clinical Job Details

Stability Scientist

Job Code: #747
Job Type: Contract
Salary: $25.00 - $28.00/hour
Job Location: Melrose Park, IL
Posted yesterday

Job Description

Title:  Stability Scientist

Pay:  $25.00 - $28.00

Job Overview:  The Scientist for Stability Coordination in Formulation Development is responsible for cGMP activities supporting execution of the ICH stability study program for IND/NOA/ANDA applications. The position is an interdepartmental liaison which directly interfaces with manufacturing, laboratory, quality, and regulatory personnel to ensure compliance of the stability program, to furnish complete and accurate stability information, and to provide consultation on product stability behavior. 
•    Administers the stability database and acts as gatekeeper for all data and information to be reported
•    Contributes to drafting and execution of stability testing protocols and labeling study protocols
•    Provides technical review of change control for protocols and database management
•    Manages accurate distribution and chamber inventory of stability samples
•    Communicates monthly schedule and subsequent revisions
•    Manages testing logistics of stability samples, tracks progress, and obtains results generated by on-site and off-site laboratories
•    Records specifications, test results, investigations, and supporting information to prepare accurate and complete stability summaries
•    Assists in evaluation and interpretation of test results, trending, and statistical data analysis to support proposed shelf-life
•    Clearly communicates all past due items or compliance issues to management
•    Provides stability summary reports and periodic updates to Regulatory Affairs and
project team
•    Supports completion of Quality Assurance audit responses via any related updates to reported stability data, stability summaries, SOPs, or other corrective action required
•    Coordinates activities for multiple projects and ensures timely completion based on stability schedule, SOP requirements, and department goals
•    Performs stability related investigations and implements corrective actions
•    Evaluates information management requirements and contributes to validation of new systems, platform upgrades, or data migration
•    Performs other duties as assigned to support stability program compliance and business goals

Requirements:
•    BS/BA in a scientific discipline with one to three years, or a Master's degree with zero to three years, of related experience
•    Skills in designing and executing experiments, interpreting test results, analyzing causes of variations, and performing basic statistical analysis
•    Excellent written and oral communication skills
•    Flexible, adaptive, strong desire to work in a dynamic environment, responsive to urgency
•    Self-motivated, empowered personality, result- and deadline-oriented
•    Strong organizational skills, attention to detail, interpersonal skills, and ability to manage competing priorities are essential for success
•    Ability to perform light to moderate physical labor, at times briefly under conditions of extreme heat, cold, and humidity
•    Willing to commute between multiple locations for stability samples storage and retrieval