Stability Coordinator

Summit Biosciences - Lexington, KY2.1

Full-timeEstimated: $39,000 - $50,000 a year
The Stability Coordinator is responsible for managing all QC and Pharmaceutical Development stability programs. The individual will coordinate and oversee all stability testing. The Stability Coordinator reports to the Sr. Manager Quality Control Chemistry.

Essential Duties:
Work in a safe manner in accordance with site procedures.
Draft stability protocols and amendments.
Initiate new stability studies.
Update/maintain stability schedule.
Receive stability samples, store stability samples and pull stability samples on scheduled pull dates.
Ensure stability samples testing, in-house or external, occurs in a timely fashion.
Manage stability chamber inventory and storage capacity.
Ensure stability chambers are maintained in a calibrated/qualified state.
Manage stability sample disposition.
Create stability summary report templates for each stability study.
Review data and stability summary reports.
Identify out of specifications and out of trend test results.
Oversee and actively participate in investigations for stability test results.
Write, revise and review Standard Operating Procedures pertaining to the stability program.
Perform data trending analyses.
Interpret degradation products testing.
Ensure stability activities are compliant with SOPs, cGMPs and ICH guidelines.
Work to continuously improve stability operations
Strong oral and written communication skills. Clearly and concisely articulate details in a professional manner.
Able to manage multiple projects efficiently to meet deadlines.
Other duties as assigned.

Essential, skills and abilities:
Knowledgeable in ICH guidelines: Stability and Impurities
Sound understanding of chromatography and degradation products testing.
Ability to multitask and adjust priorities.
Strong organizational skills.

Bachelors in Chemistry or related field with at least 5 years pharmaceutical industry experience
Qualified to work with controlled substances