Stability Scientist I

PURPOSE AND SCOPE

Captures stability programs and facilities. Reviews for completeness, verifies and enters stability data into the stability database.

Principal Duties and Responsibilities

• Reviews notes and test methods and compare information with final reports to detect errors and ensure completeness and conformity to SOPs and regulatory guidance.
• Captures drug and device stability studies.
• Captures stability chamber space and environmental conditions, including product levels and mechanical maintenance.
• Maintains data base and spreadsheets.
• Assists the drug/device laboratories with stability testing using various techniques as required by respective projects based on current training and capabilities.
• Compares input and output data and calculations for correctness.
• Assists in stability study maintenance projects and laboratory quality improvement projects.
• Loads and pulls stability samples into/from the stability chambers. Delivers samples to the respective testing laboratories testing.
• Gathers and reviews data related to stability testing and compiles into respective study files. Enters respective data into the stability database for review and approval.
• Works closely with the Stability Scientist II on stability-related issues/projects.
• Maintains general housekeeping of working area, environmental chambers and proximal plant areas.
• Builds stable working relationships internally.

Drug Stability Duties

• Coordinates drug stability studies.
• Oversees drug product levels and inventories.
• Compiles and submits Annual Drug Product Review data to respective ADPR team leaders.
• Maintains drug environmental storage conditions. Assures proper environmental chamber operation and maintains environmental conditions.
• Performs chamber reprofiles for drug chambers as required.
• Performs annual test method, instrument qualification and software validation reviews in accordance with the respective PM requirements.

Device Stability Duties

• Coordinates device stability studies.
• Oversees device product levels and inventories.
• Provides device-related stability reports and data to respective study leaders as required.
• Maintains device environmental storage conditions. Assures proper environmental chamber operation and maintains environmental conditions.
• Performs chamber reprofiles for device chambers as required.
• Performs annual test method, instrument qualification and software validation reviews in accordance with the respective PM requirements.

Physical Demands and Working Conditions

• Regularly required to use hands and fingers to handle and talk or hear.
• Frequently required to stand; walk; sit; reach with hands and arms and wear personal protective equipment that may include Safety glasses, etc.
• Occasionally required to climb or balance and stoop, kneel, crouch, or crawl.
• Must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.
• Occasionally exposed to wet and/or humid conditions; moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals and risk of electrical shock.
• The noise level in the work environment is usually moderate.

Experience and Required Skills

• Bachelor’s degree in chemistry or closely related science field required.
• Minimum 1 – 2 years’ stability or laboratory related experience.
• Ability to read, analyze, and interpret general business periodicals, professional journals, science journals, technical procedures, or governmental regulations.
• Strong oral and written communication skills.
• Ability to apply advanced mathematical concepts.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
• Proficient with PC operating systems, Windows a plus.
• Experience in Microsoft Office applications.
• Knowledge in cGMP, Drug and device processes a plus.