AMANDA BYARS

**** ******* **. **, ***** Cross Roads, AL 35763

256-***-**** - adr6vh@r.postjobfree.com

PROFESSIONAL SUMMARY

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 types of analysis. SKILLS

• Complex Problem-Solving

• Team Collaboration

• Self-motivated professional

• Proton NMR, Carbon-13 NMR, 2D

NMR

• UPLC, HPLC, Prep HPLC, icIEF

(Maurice)

• KF and acid-base titrations

• Some GC-MS, LC-MS, FTIR, and

UV-Vis experience

• AKTA and some TFF Purification

• Instrument Calibration and Basic

Repairs Knowledge

• Process and Analytical Development

• Experienced with GMP Standards and

SOPs

• API Handling

WORK HISTORY

07/2015 to 04/2022 Process Development Associate III Nektar Therapeutics – Huntsville, AL

• Prioritized project tasks after discussions with Process Development department project team.

• Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.

• Conducted research and investigations into impurities that arose during experiments.

• Conducted moderately complex analysis and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.

• Produced detailed and relevant reports for use in making business decisions. 05/2007 to 07/2015 Process Development Associate II Nektar Therapeutics – Huntsville, AL

• Read literature related to scientific area of expertise to remain current in knowledge.

• Compiled research data and gave professional presentations highlighting finds and recommended optimizations for use in making business. decisions.

• Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.

• Conducted experiments in laboratory environment for product development purposes in compliance with regulatory agencies and safety requirements.

• Coordinated and performed analytical tests to comply with established standards and specifications.

• Cleaned and organized laboratory and kept supplies well-stocked to save time, money and promote laboratory efficiency.

09/2006 to 05/2007 Manufacturing Technician II

Nektar Therapeutics – Huntsville, AL

• First 3 months with Aerotek temp agency

• Made sure that products were produced on time and are of good quality that adhere to customer specifications.

• Collected and reviewed chemistry process and process workflows to assess needs and recommend solutions or optimal improvement approaches.

• Assessed and optimized 2 Manufacturing processes so that suites ran smoothly and produced quality product efficiently and on.

• Prepared standard operating procedures, manufacturing batch records and productivity reports.

• Calibrated machines to maintain required productivity levels and adherence to quality standards.

03/2000 to 06/2006 Certified Pharmacy Technician

Southern Family Market – Muscle Shoals, AL

• Answered incoming phone calls and addressed questions from customers and healthcare providers.

• Completed paperwork, entering prescription and insurance or billing information into patient profiles.

• Coordinated verification and filling of daily prescriptions in high-volume pharmacy environment.

• Stocked, labeled and inventoried medication to keep accurate records.

• Resolved non-routine issues like third-party billing, computer system and customer service issues.

• Maintained proper drug storage procedures, registries, and records for controlled drugs.

EDUCATION

06/2014 Master of Science: Chemistry

University of Alabama in Huntsville - Huntsville, AL 06/2006 Bachelor of Science: Biology And Chemistry (Double Major) University of North Alabama - Florence, AL

RELEVANT EXPERIENCE AND ACCOMPLISHMENTS

• 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.

Contact this candidate