Provide laboratory and other scientific support, e.g., literature searches, data analysis, reporting etc. in the development of an Accelerated Stability Assessment Program within the Analytical Sciences Department. Scope of Services:
Provide scientific support services to include:
- Provide support in the design and execution of accelerated stability studies for commercial and prototype products.
- Provide support in the development of an accelerated stability testing program based on the ASAP approach.
- Provide laboratory analysis of samples and collaborate with other scientists to fully characterize stability study samples.
- Maintain detailed records of the work conducted, and provide updates, written reports, or presentations to ALCS leadership.
- Degree in Chemistry, Pharmaceutical Science, Food Science or similar, plus a minimum of at least 5+ years' relevant industry experience is required.
- Working knowledge of industry standards and regulatory requirements pertaining to pharmaceutical stability and/or food product shelf-life testing. Experience in conducting accelerated drug/food product stability testing.
- Hands-on experience with analytical techniques such as UPLC/HPLC, GC-MS, Dissolution, KF titrations, Thermogravimetric analysis DSC/TGA, particle size, disintegration, FTIR.
- Knowledge and understanding of quality control, and general requirements for laboratory quality systems e.g., ISO17025, cGMP.
- Familiar with ICH guidelines for stability testing, general knowledge of stress testing, forced degradation, and related product testing protocols.
- Familiar with ASAPprime and ASAPdesign software based on the Accelerated Stability Assessment Program (ASAP).
- Skills to establish testing plans, experimental designs, and to organize and maintain large data sets.
*** For Immediate Consideration, Please email Katie at
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