The Senior Stability Analyst is responsible for assisting in the management of TRCs Stability program including ongoing commercial stability and new product development stability. Responsible for ensuring the proper controls are maintained on sample management and stability equipment to ensure audit readiness. The Senior Stability Analyst coordinates data entry activities within the team and will assist management with analyzing the data for any stability trends and alert of any possible OOT/OOS. The position is also responsible for assisting in the generation, review, approval, and implementation of stability protocols and the preparation of interim and final stability reports.

Responsibilities:

• Ensures that annual requirements are meet, and works with internal and external groups for developmental project needs. Keeps management informed and obtains managements guidance for priorities and concerns.


• Updates stability program SOPs as required.


• Assists in tracking and timely completion of all stability program activities.


• Verifies monitoring and maintenance of the stability chambers are properly maintained.


• Evaluates storage capacity to ensure that TRC has adequate stability storage for ongoing and planned projects. Includes assisting management with chamber management decisions, change control requests, request for new capital.


• Assist is cost analysis (bids/change orders) for new business needs.


• Ensures and maintains approved stability protocols for commercial and PD products.


• As team lead, communicates weekly stability activities/timelines and coordinates stability activities with the team.


• Assists management in trending of stability data and alert management of any OOS or OOT values.


• Collaborate in OOS investigations or OOT investigations for stability samples.


• Ensuring all chemical and microbiology tests associated with drug product stability studies are completed per approved TRC SOPs.


• Document raw and final data to ensure complete and proper documentation according to applicable procedures and cGMPs.


• Assist in stability specific method transfers or validation.


• Ensure documentation is filed or archived properly.


• Assist in special projects as requested by the Stability Program Manager.


• Assist in review and implementation of regulatory requirements for stability program.


• Follow Standard Operating Procedures, safety, health, and cGMP Guidelines.

Qualifications:

• BS in Chemistry or related field


• A minimum of 5 years of analytical experience in a GMP laboratory or research setting


• 5 years of experience in stability programs, with a minimum of 3 years of experience with stability testing and specifications requirements


• Working knowledge of regulatory guidances for stability storage and testing


• 2 years of technical writing experience (SOP, Regulatory submissions, technical reports)