Amanda Byars

Experienced Process Development Analytical Chemist with a Master of Science degree in Chemistry. Encompasses over 15 years of experience in cGMP Pharmaceutical/Biotech laboratory research environment as well as over 5 years in a Pharmacy setting. Skilled with handling and testing API and CDS materials while adhering to cGMP/cGLP guidelines. Excellent reputation for resolving problems and improving customer satisfaction. Enthusiastic and eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of analytical analysis and training in NMR (Proton, C13, 2D NMR), HPLC, Prep. HPLC, UPLC, and some experience on many more wet chemistry and other types of analysis. Motivated to learn and excel in an analytical role performing method development, method validations, and increasing experience in analytical methods such as LC-MS, GC-MS, and any other type of analysis.

• Worked extensively with analytical development isolating peaks with a Waters preparative HPLC system equipped with a UV and MS detector to support the NDA to strengthening the current assignments through direct isolation.
• Provided analytical support by synthesizing impurity markers for GMP analytical methods.
• Conducted UPLC, NMR, KF, and titration analysis of experimental samples to determine purity and related substance (UPLC), the wt% (by NMR and UPLC), water content (KF), phosphate content (titration), and the amount of tribuytlamine and mPEG5-vinyl in NKTR-181 free base or NKTR 181 phosphate salt (NMR).
• Conducted preparative HPLC experiments to isolate various targeted impurities to use as impurity markers in NKTR 214 HPLC and icIEF analysis of intermediates and final product. The following impurities were isolated: Di-PEG, tri-PEG, and penta-PEG species. The Protein/Biologic team analyzed and reconstituted the samples after isolation.
• Conducted analysis using Maurice instrumentation to determine the profile of the charge variants/PEGylation profile of NKTR 214 Drug substance (DS) and Drug product (DP) by using an Imaged Capillary Electrophoresis Isoelectric Focusing (icIEF) method.
• Conducted mPEGNH2 10K experimentation such as use test and impurity synthesis. Performed proton NMR analysis for sample purity and total hydroxyl content. Investigated an isobutyric acid impurity generated by the addition of contaminated MTBE. Investigated and unknown impurity that was detected in the final product by NMR and determined that the unknown washed out with additional washes of MTBE. Investigated another impurity by NMR that was generated by the alkylation of the amine with DCM during processing when the material was left in DCM for an extended period of time.
• Conducted experiments to determine the binding capacity of a mono pegylated amine species as well as the residual mPEGAmine 10K generated during the C2PEG2OH 40K purification process to aid in confirming PAR values set for the amount of media used in the GMP manufacturing process.
• Collaborated with team of 6 in the development of NKTR 181 by conducting experiments to help the process development team better understand the results of various changes in the optimization process and ultimately aid the team in making critical process decisions.
• Collaborated with manufacturing to support them when deviations arose during GMP manufacturing to determine the root cause of the problem and determine whether the batch could be recuperated. On numerous occasions, I aided them in performing analytical analysis to identify an unknown impurity in raw materials found in raw materials or performed experiments to pave a path forward.