Job Description:
This is what you will do:
The Stability Associate II is responsible for performing assigned tasks to support stability activities for the client’s clinical phase candidates from development through Phase III and support Commercial Products. The Stability Associate II will work in collaboration with members of Analytical Sciences (AS), Biological Drug Substance Development (BDSD), Injectable Drug Product Development (IDPD), Device Development (DD), Quality Assurance (QA), and other members of Product Development and Clinical Supply (PDCS) as well as external vendors as required.
You will be responsible for:
- Responsible for all aspects of on-site stability sample storage and sample management
- Conduct Stability sample pulls at scheduled timepoints according to approved stability study plans
- Deliver stability samples to labs and perform aliquots as needed, following Good Documentation Practices (GDPs) and Good Laboratory Practices (GLPs)
- Perform data entry/review within paper-based and electronic systems
- Point-of-contact between on-site testing labs and stability group
- Author stability Protocols, Reports, SOPs and Quality documents as required
- Work with internal stakeholders to provide testing requirements and obtain completed analytical test results
- Track stability results generated internally and at external CMOs/ CLOs
- Document stability results with a strong attention to detail; able to recognize trends outside of expected results and communicate to management as required
- Perform all job functions in compliance with cGMPs and maintain accurate and legible records
- Ensure training is current for all job functions performed. Attend all required Company training
You will need to have:
- Bachelor’s degree with previous experience in an appropriate scientific discipline (Biochemistry, Biomedical Engineering, Chemical Engineering or related discipline consisting of a combination of appropriate education, training and/or directly related experience)
- Knowledge of GxPs and their application in the pharmaceutical environment is required
- Able to organize his/her own work on a routine basis and requires minimal supervision. When asked, the individual is able to provide updates and tracking on his/her tasks
- Ability to interact with cross-functional teams while representing the stability group
- Able to navigate external vendor sites and portals for data extraction and review, as needed
- Able to communicate findings effectively to colleagues within and outside of the group through presentations
- Proficient with various MS Office programs, including Word, Excel, Outlook, and PowerPoint
- The ability to communicate verbally and in a written format is required
- Able to understand and follow written procedures
- The duties of this role are generally conducted in an office/lab environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer you to have:
- Working knowledge of governing documents/regulations for pharmaceutical stability
- Previous technical writing experience
- Previous experience with SAS JMP or other statistical software
- Previous experience with Laboratory Information Systems (LIMS)
