R&D Chemist-Stability Coordinator
Tri-Pac Inc
- South Bend, IN
- Permanent
- Full-time
- You will report to the R&D Manager, and will work onsite at our Kenmore location in South Bend, IN.
- This will include initiating stability studies, coordinating stability pulls, making sure the testing schedule of stability samples is met, analyzing stability data, and evaluating trends, and writing stability reports.
- To author stability protocols, interim reports, and reports for stability studies
- This includes routine campaign stability studies and non-routine project stability studies.
- Report the trending of stability data through data management and trend analysis using appropriate software.
- To escalate any trends to the R&D Manager and support any investigations, based on the test data collected.
- To support the business in requests relating to stability data (including temperature excursion assessments, regulatory requests, and investigational work)
- To own and support stability related Deviations, CAPAs and Change Controls, and progress department improvements.
- Manage stability studies following internal procedures, ensuring studies are set up per the protocol.
- The Stability Coordinator will interact with other groups in R&D and other departments (such as QC and production) as required.
- Will collaborate with relevant QC laboratories to ensure stability samples are tested within their specified time frame for actives, and micro.
- Coordinate the shipment of stability samples to outside labs when required.
- Maintain stability tracker for routine annual stability and lab stabilities.
- Good knowledge about lab equipment/test – Viscosity; pH; specific gravity; API’s etc.
- Knowledge of cGMP regulations; GLP.
- Support R&D lab with formulation development for OTC; Cosmetic and Medical device in different forms – Aerosol; liquid and BOV.
- Improve current product formulations.
- Lead formulation development activities with a focus on stability as the primary responsibility.
- Proficient in Microsoft office 365.
- Associate or bachelor’s (B.A or B.S) in a scientific discipline; and 2 or more years related experience and/or training; or equivalent combination of education and experience.
- Must demonstrate knowledge of common analytical tools and techniques.
- Must have previous experience with conducting stability studies and knowledge of statistics.
- Must have previous experience in a GMP environment.