Amanda Bower Email and Phone Number

Work effectively with external vendors to assist in development of methodologies for analytical characterization, raw materials, intermediates, drug substance and drug products that are phase appropriate and aligned with manufacturing, development and commercial requirements.Additionally,1. Provide troubleshooting and technical guidance to external analytical partners.2. Review analytical method qualification/validation/transfer documentations for accuracy, completeness and adherence to GMPs.3. Lead in development and justification of specifications, review of release and stability data and resolution of investigations/deviations.4. Author relevant CMC sections for INDs and NDAs.

• Analytical lead for analytical technology transfer / project support function of Quality Control and Compliance of a late phase biological drug candidate.• Responsible for ensuring timely analytical technology transfer from early process development as required to support US pilot plant and outsourced activities as well as any analytical technology transfer to late-stage Biopharmaceutical Development and/or a contract facility• Oversee the analytical technology transfer process for projects from analytical plan development through the technology transfer report• Responsible for overseeing other project support functions such as authoring/reviewing CMC sections for regulatory submissions • Participate in developing qualification/validation strategies.

Quality lead for API manufacturing site responsible for batch record review, quality system management, audits and quality technical agreement authoring.

Provided quality and technical support to external analytical laboratories for routine testing and analytical tech transfers. Performed quality oversight of laboratories through audits and authoring of quality technical agreements.

Lead analyst with extensive experience performing analysis of drug products, raw materials, and stability samples utilizing HPLC, dissolution, UV-Vis and various analytical tests. Promoted twice during my tenure and achieved increased responsibility and oversight of laboratory activities

Performed a variety of analytical tasks for the analysis of drug product and stability samples by means of HPLC, Karl Fisher, and wet chemical analysis. Lead analyst that was responsible for overseeing the timely completion of two substantial long term stability studies.

Worked as a Chemist during my final semester at Lock Haven University as a co-op for the product development team for solvent and emulsion based adhesives. Assisted with testing in the quality control laboratory for release of marketed product and performed testing for product developement with Research Chemists.