Phillip Atkinson

Experience

• 

  PPD

  Jan 2004 - Sept 2012

  Managed a team of analytical chemists and acted as principal investigator for analytical drug analysis, overseeing daily operations, ensuring scientific integrity, and GLP compliance while maintaining tight production timelines • Developed team members, increasing their ability to be adept problem solvers effective in both team and individual roles • Facilitated client audits of ongoing analytical drug studies involving various pharmaceutical companies and participated in FDA audits ensuring site regulatory compliance• Developed and maintained key client relationships establishing direct communications and efficient project oversight both internally and externally, while decreasing communication redundancies • Wrote analytical methods and oversaw technical report writing for stability, method validation, and client studies to ensure project integrity and regulatory compliance • Established and managed client programs for analytical analysis of long-term clinical and stability projects• Provided developmental testing for the implementation of electronic notebooks, increasing data integrity and decreasing QC/QA review time Show less Performed the role of project leader overseeing multiple clinical projects and individuals while providing guidance and training for scientists and associate scientists• Performed analytical data review of all stability, validation, and clinical study data to ensure scientific integrity• Established and maintained client communications to ensure that GLP guidelines, SOPs, and best practices were maintained, decreasing the occurrence of procedural deviations • Maintained tight production timelines and data throughput as they evolved per both internal and external influences, increasing productivity and client satisfaction • Developed effective and efficient troubleshooting techniques for analytical drug extraction methods and instrumentation, minimizing downtime and maximizing cost effectiveness Show less

  • Associate Group Leader

    Jan 2012 - Sept 2012

  • Senior Scientist

    Jan 2008 - Dec 2011

  • Scientist

    Jan 2005 - Dec 2007

  • Associate Scientist

    Jan 2004 - Dec 2004
• 

  Boehringer Ingelheim

  Sept 2012 - Dec 2014

  Stability Coordinator

  Managed the active pharmaceutical ingredient (API) stability program, overseeing analytical testing, technical report writing, and program regulatory compliance demonstrating long-term product quality• Managed ~150 active stability studies across 15 products in accordance with ICH, GMP, and DEA guidelines• Routinely investigated/documented atypical results, audit findings, and/or procedural deviations, and implemented corrective actions/preventative actions (CAPAs) for continuing quality improvement• Developed a cross-functional site communication network of subject matter experts (SMEs), significantly reducing discovery and reporting time of atypical events, ultimately reducing corporate and regulatory site compliance risks • Upon hiring, performed a comprehensive program analysis (e.g., regulatory requirements vs. implemented studies) resulting in a 25% reduction in overall studies and significant cost savings• Presented/defended analytical data and addressed inquires in FDA, client, and various regulatory agency audits to demonstrate site regulatory compliance and overall product integrity• Managed multiple outside contractors ensuring integrity of work, maintaining preventative maintenance timelines, and negotiating contracts• Created and maintained Standard Operating Procedures (SOPs) in accordance with evolving regulations, ensuring site regulatory compliance BICI Site Closure Responsibilities• Managed the qualification of a contract research organization (CRO) and subsequent transfer of the BICI’s stability program testing • Managed the qualification of a Boehringer-Ingelheim affiliate site and subsequent transfer of BICI stability program oversight Show less

• 

  PPD

  Jun 2015 - Aug 2016

  Associate Group Leader

  Managed a team of analytical chemists and acted as principal investigator for analytical drug analysis, overseeing daily operations, ensuring scientific integrity, and GLP compliance while maintaining tight production timelines • Developed and maintained key client relationships, establishing direct communications and efficient project oversight to ensure contractual budgets and timelines are upheld• Reviewed and approved laboratory testing data, facilitated QC/QA review, and oversaw technical report writing for client studies to ensure project integrity and regulatory compliance• Developed team members, increasing their ability to be adept problem solvers effective in both team and individual roles • Facilitated client audits of ongoing analytical drug studies involving various pharmaceutical companies and participated in FDA audits ensuring site regulatory compliance• Established and managed client programs for analytical analysis of long-term clinical and stability programs Show less

• 

  Kaléo

  Aug 2016 - now

  Manage Quality Control group providing program guidance and direct report oversight/development• Oversee all Quality Control activities for drug and device constituents at CMOs and CROs (e.g., analytical analysis (development and commercial), data tracking and trending, Full Time Equivalent (FTE) laboratory analysis program, etc.) • Establish, monitor, and review kaléo, CMO, and CRO Key Performance Indicators (KPIs) for Quality Control as part of continuous improvement, risk mitigation, and management review/escalation• Act as Quality Project Manager for development initiatives and coordinate applicable change records (e.g., method transfer/development, alternate supplier qualification, development stability programs, etc.)• Perform and coordinate cross-functional investigations and implement corrective actions/preventative actions (CAPAs) both internally and externally (e.g., atypical, out-of-trend (OOT), out-of-specification (OOS), etc.)• Perform on-site supplier audits ensuring compliance with both kaléo (e.g., Master Service Agreement (MSA) and Quality Agreement (QA)) and regulatory agency guidelines (drug product and device constituent)• Support regulatory agency inspections as subject matter expert (SME) and key backroom support member for audit facilitation Show less Managed the pharmaceutical stability program for developmental and commercial products• Provided supplier oversight for analytical testing (drug product and device constituents)• Worked with suppliers (manufacturing and testing), legal, and finance to establish Statements of Work (SOWs), Purchase Orders (POs), and Stability Protocols for both commercial and developmental stability projects• Initiated and coordinated investigations (internal and external) via Master Control (i.e., atypical, out-of-trend (OOT), out-of-specification (OOS), etc.)• Developed and maintained SOPs for Quality Control program management • Collaborated with drug, device, and manufacturing SMEs on stability study design for developmental projects• Managed stability tracking and trending tools (i.e., Klipfolio, Excel Spreadsheets, etc.) and lead Key Performance Indicator (KPI) review meetings• Prepared Stability sections of Annual Product Reviews (APRs), FDA Annual Reports (ARs), and New Drug Applications (NDAs) Show less

  • Director, Quality Operations

    Nov 2021 - now

  • Quality Control Manager

    Apr 2018 - Nov 2021

  • Stability Program Coordinator / Data Analyst

    Aug 2016 - Mar 2018