Ashleigh Rosier
Glen Allen,VA
Summary
I am a dependable hardworking project manager with over ten years of experience in the clinical research organization industry . My expertise lies in large molecule immunoassays. I am fully committed to achieving timelines and assisting sponsors to get their drug compound on the market.
Overview
10
10
years of professional experience
Work History
Group Leader
PPD
Richmond, VA
01.2023 - Current
- Manage a team of ten scientists and managers directly supporting their career growth and providing mentorship
- Manage ~60 PK, ADA, Nab, sample analysis, and validation bioanalytical studies in support of clinical trials for biosimilar and antibody-drug conjugates
- Serve as a principal investigator and key client contact to support all bioanalytical studies
- Serve as a key member of the company’s interview panel
- Prepare study protocols, project status reports, final study reports, and other project-related technical documentation
- Design experiments and participate in technical troubleshooting
- (Electrochemiluminescent, ELISA, TECAN, and Gyrolab platforms)
- Review, interpret and analyze data for technical quality and compliance to protocols, methods and SOPs
- Review laboratory investigations and deviations
- Lead client and FDA audits
- Organize, schedule and supervise laboratory resources for group's project activities and update project status
- Prioritizes project activities with internal functional groups to support sponsor timelines
- Responds to client questions and needs, coordinates client communication and leads client technical meetings
- Pursues new business opportunities with client base and assists in preparation of proposals
- Prepare and implement SOPs and company operational policies.
Associate Group Leader
PPD
Richmond, VA
04.2019 - 01.2023
- Manage a team of six scientists directly supporting their career growth and providing mentorship
- Manage ~80 PK, ADA, Nab, sample analysis, and validation bioanalytical studies in support of clinical trials for biosimilar and antibody-drug conjugates
- Serve as a principal investigator and key client contact to support all bioanalytical studies
- Serve as a key member of the company’s interview panel
- Prepare study protocols, project status reports, final study reports and other project-related technical documentation
- Design experiments and participate in technical troubleshooting
- (Electrochemiluminescent, ELISA, TECAN, and Gyrolab platforms)
- Review, interpret and analyze data for technical quality and compliance to protocols, methods and SOPs
- Review laboratory investigations and deviations
- Organize, schedule and supervise laboratory resources for group's project activities and update project status
- Responds to client questions and needs, coordinates client communication and records meeting minutes.
Senior Scientist
PPD
Richmond, VA
09.2017 - 03.2019
- Served as the lead scientist on all high throughput sample analysis and validation projects
- (Electrochemilumiscent, ELISA, TECAN, and Gyrolab platforms)
- Routinely reviewed and evaluated data and laboratory notebooks for regulatory compliance
- Authored and reviewed sample analysis and validation reports ensuring accuracy of the data and overall study quality
- Served as a principal investigator for over fifteen GLP and non-GLP studies
- Communicated directly with clients to ensure smooth progress through studies
- Managed laboratory staff, equipment, and resources.
Scientist
PPD
Richmond, VA
05.2016 - 09.2017
- Served as a lead scientist managing validation and sample analysis progress within the lab
- Handled all biotinylation and ruthenium conjugation procedures
- Validated PK and immunogenicity (ADA and NAb) assays
- Utilized BEAD, SPEAD, and ACE methodologies for immunogenicity
- Became proficient at operating Gyrolab platform for assay validation and sample analysis purposes
- Successfully managed RIA assays
- Served as a radioactive material handler and trainer
- Served as a lead CLIA analyst
- Managed data to help with table formation and QC review on sample analysis and validation projects
- Served as a trainer for junior analysts.
Associate Scientist
PPD
Richmond, VA
04.2015 - 04.2016
- Perform complex sample analysis procedures to quantitatively measure pharmaceutical compounds while developing skills to troubleshoot potential assay issues
- Prepared controls in a variety of biological matrices for PK and ADA assays using both manual and TECAN liquid handling techniques
- Worked closely with the development team to troubleshoot assay performance issues
- Participated in peer review of completed data and laboratory notebooks.
Assistant Scientist
PPD
Richmond, VA
07.2014 - 04.2015
- Performed PK and immunogenicity sample analysis procedures in support of large molecule drug development
- Followed analytical methods and SOPs for ELISA and Electrochemiluminiscent assays
- Prepared buffers needed to perform sample analysis
- Became proficient with GLP documentation practices and LIMS usage.
Education
Master of Science (M.S.) - Pharmaceutical Sciences -
University of Florida
Gainesville, FL12.2021
Bachelor of Arts (B.A.) - Biological Sciences -
Rutgers University
New Brunswick, NJ05.2013
Associate of Science (A.S.) - Biology Sciences -
Ocean County College
Toms River, NJ05.2011
Skills
- Microsoft Word
- Microsoft Excel
- Microsoft Powerpoint
- Nitro Pro
- Adobe Pro
Timeline
Group Leader
PPD
01.2023 - Current
Associate Group Leader
PPD
04.2019 - 01.2023
Senior Scientist
PPD
09.2017 - 03.2019
Scientist
PPD
05.2016 - 09.2017
Associate Scientist
PPD
04.2015 - 04.2016
Assistant Scientist
PPD
07.2014 - 04.2015
Master of Science (M.S.) - Pharmaceutical Sciences -
University of Florida
Bachelor of Arts (B.A.) - Biological Sciences -
Rutgers University
Associate of Science (A.S.) - Biology Sciences -
Ocean County College