Rebecca Carmean
Chesterfield
Summary
Motivated, efficient, and collaborative scientist with 17 years of CRO experience. I serve as a mentor, leading projects as a principal investigator/project manager, and people management. Comprehensive experience cell-based neutralizing antibody (NAb) assay method development and validation, and sample analysis. Seeking opportunities to grow and expand my knowledge in the pharmaceutical industry Excellent presentation development and delivery skills Staff scientist management, supervision, and mentorship Working with cross-functional groups (QC/QA, BD, sponsors). I have analytical method development and validation skills, effective project management skills, strong interpersonal, written, and oral communication and skills and have cultivated trusted relationships with internal and external customers.
Overview
18
18
years of professional experience
Work History
Associate Director
PPD, Part of Thermo Fisher Scientific
01.2021 - Current
- Continued a record of excellent service to the pharmaceutical industry by continuing to perform the duties of a Manager and added additional responsibilities:
- Managed the budget for projects, rate-cards for sponsor specific pricing
- Assisted in the preparation and editing of Standard Operating Procedures (SOPs)
- Collaborated with Quality Control, Quality Assurance, Business Development
- Continuously updated practiced based on FDA guidance
- Consulted with new sponsors for initiating work
- Trained and developed department leaders and management staff for specific projects and ongoing operational needs.
- Assisted senior leadership in managing all aspects of operations.
- Communicated all capacity, sourcing and technology gaps with upper management.
- Prioritized tasks and allocated resources appropriately to keep teams focused and productive.
- Interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
Manager (Research Scientist/Principal Investigator)
Pharmaceutical Product Development, Inc, PPD, Inc
01.2019 - 01.2021
- Continued to perform tasks associated with a Senior Group Leader and added responsibilites:
- Managed and motivated employees to be productive and engaged in work.
- Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
- Planned and budgeted accurately to provide business with resources needed to operate smoothly.
- Reviewed SOPs and all reports generated from principal investigators within my group.
Senior Group Leader (Senior Research Scientist/Principal Investigator)
Pharmaceutical Product Development, Inc, PPD, Inc
01.2013 - 01.2019
- Continued a record of excellent service to the pharmaceutical industry by continuing to perform the duties of a Group Leader with added responsibilities:
- Supervised junior scientists and principal investigators
- Worked with the bids and proposals team to generate pricing, rate cards, and proposal information.
- Interviewing and hiring of new employees
- Scheduling and budgeting of the lab.
Group Leader (Research Scientist/Principal Investigator)
Pharmaceutical Product Development, Inc, PPD, Inc
01.2009 - 01.2013
- Continued a record of excellent service to the pharmaceutical industry by continuing to perform the duties as an Associate Research Scientist
- People leading with direct reports
- Delegated tasks strategically and monitored progress for timely completion.
- Collaborated with cross-functional teams to maintain project progress.
Associate Group Leader (Associate Research Scientist/Principal, Investigator
PPD, Inc
01.2006 - 01.2009
- Established the cell-based assay team in Richmond, VA as the first principal investigator and project lead
- Trained and mentored scientists within the cell-based neutralizing antibody (NAb) assay team
- Communicated effectively and regularly with clients regarding data and project specific requests
- Assisted clients with cell-based neutralizing antibody (NAb) assay method design, validation, and sample analysis.
- Drafted validation plans and bioanalytical plans as per the current FDA guidance for GLP studies.
- Instituted the first cell-based NAb assay performed under Clinical Laboratory Improvement Amendments (CLIA) guidelines at PPD.
- Reviewed data and monitored data trending in accordance with standard quality assurance practices
- Performed assay troubleshooting as needed in order to ensure vertical success of the assay
- Collaborated with management and fellow Principal Investigators, and quality groups to ensure quality data is delivered to sponsors.
Education
Doctor of Philosophy - Microbiology and Immunology
VCU
Richmond, VABachelor of Science - Biology
Washington College
Chestertown, MDSkills
- Usage of software including but not limited to : Laboratory information management systems (LIMS), ECM, BioVia CISPRO, IDBS, plater-reader software, GraphPad, Microsoft series
- Development, Validation, and Sample Analysis of Cell-Based NAb assays
- Process Improvement and Project Management
- Coaching and Mentoring
- Analytical Thinking and Assay Troubleshooting
- Staff Scheduling and Budgeting
- Team Leadership
Accomplishments
- Myler, H et al., Neutralizing Antibody Validation Testing and Reporting Harmonization. AAPS J. 2023 Jul 8;25(4):69. doi: 10.1208/s12248-023-00830-5. PMID: 37421491.
- Neutralizing Antibody Reporting Harmonization (white paper in progress)
- MacLean R.C., Leu K., Jolicoeur P., Tacey R., Green J., Schatz P. Validation of a cell-based assay for the quantification of Hematide™-specific neutralizing antibodies in clinical serum specimens. Presented at: 2009 AAPS National Biotechnology Conference. Seattle, WA, USA, 21–24 June 2009.
- MacLean R.C., Jolicoeur P., Tacey R., Nelson III, O, Bourdage J.S., Fuerst T.R., Fusco P.C. Development and Validation of a Cell-Based Assay for the Detection of Valortim® in New Zealand White (NZW) Rabbit Serum Samples. Presented at: 2012 AAPS National Biotechnology Conference. San Diego, CA, USA, 21–23 May 2012
- Garshick (MacLean) R.M., Lilolia C. Bioassay Challenges, podcast, 2020; https://www.ppd.com/resource/ppd-laboratories-bioassay-challenges/
- Garshick (MacLean) R.M., Crowe M. AAV Assay Development & AAV Cell-Based Neutralizing Antibofy Assay Development, tech talk, 2021; AAV Assay Development & AAV Cell-Based Neutralizing Assay Development (pathfactory.com)
Affiliations
- American Association of Pharmaceutical Scientists
- Quality Assurance Professional of Good Laboratory Practices
- Computer Systems and Validation Committee
- Validation Center of Excellence Member
- Operational Oversight Committee
- 5S Team Lead
Timeline
Associate Director
PPD, Part of Thermo Fisher Scientific
01.2021 - Current
Manager (Research Scientist/Principal Investigator)
Pharmaceutical Product Development, Inc, PPD, Inc
01.2019 - 01.2021
Senior Group Leader (Senior Research Scientist/Principal Investigator)
Pharmaceutical Product Development, Inc, PPD, Inc
01.2013 - 01.2019
Group Leader (Research Scientist/Principal Investigator)
Pharmaceutical Product Development, Inc, PPD, Inc
01.2009 - 01.2013
Associate Group Leader (Associate Research Scientist/Principal, Investigator
PPD, Inc
01.2006 - 01.2009
Doctor of Philosophy - Microbiology and Immunology
VCU
Bachelor of Science - Biology
Washington College
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