amanda sanders

* Collaborating as part of an interdisciplinary team to deliver high quality and accurate data used in FDA/EMEA new drug applications * Responsible for a variety of outsourcing activities to transfer studies to contract research organizations (CROs) * Utilized electronic notebooks for paperless record keeping (21 CFR Part 11 compliant) * Conducted sample analysis in a GLP laboratory to support pharmacokinetic and drug metabolism studies for new biological compounds * Developed and validated new analytical methods for the quantitation of novel therapeutics, biomarkers, and biosimilars

* Logistics and technology transfer expert for the department * Scientific authority and manager for high throughput ELISA analysis * Responsible for organizing and streamlining documentation practices (SOPs, records, etc.) * Supervisor of other staff

During my time at PPD I was promoted from Associate Scientist to Scientist to Senior Scientist. My project management responsibilities outside of the lab were equally important. I met tight timelines, juggled multiple projects, trained and managed junior employees, and built lasting client relationships. Working at a CRO gave me exposure to dozens of different biotech and pharmaceutical companies as clients. I mastered working in a FDA regulated (GLP-compliant) laboratory which requires an strict attention to detail and meticulous documentation practices. My focus in the lab was bioanalytical assay development and validation in support of pre-clinical and clinical trials.

* SME for clinical project management on biomarkers * Creating new processes for the implementation and incorporation of biomarker testing within our clinical trials * Manager of the clinical specimen coordinator group (responsible for clinical specimen tracking) * Three direct reports * Established new roles and responsibilities for group to improve efficiency and interactions with other departments * Leading projects on: * Streamlining clinical study documentation for sample collection and processing * Review and flow of incoming scientific data from vendors * Lead contact and relationship manager for several testing vendors (outsourced work)