Stephanie L. Redus
Keedysville,Maryland
Summary
Project management professional with track record of delivering high-impact projects in diverse environments. Adept at driving project timelines and ensuring quality outcomes through strategic planning and execution. Highly collaborative, adaptable, and committed to team success and client satisfaction.
Overview
31
31
years of professional experience
Work History
Project Manager
Federal Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD)
Silver Spring, Maryland
03.2020 - 07.2025
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Collaborated closely with senior management to align project objectives with strategic OGD initiatives, ensuring that efforts contributed to overall success.
- Excellent interpersonal relationship skills and ability to collaboratively lead teams in a cohesive environment
- Developed strong relationships with stakeholders through regular communication updates, fostering trust and confidence in the team''s ability to deliver results.
- Initiated development, created documentation, implemented and monitored the Novel Complex process for challenging and complex Abbreviated New Drug Applications (ANDAs).
- Served as Project Manager for the Scientific Research Council (SRC), managed meetings, tracked topics for discussion, summaries and facilitated as needed.
- Chaired the SharePoint (SP) Coordinating Committee and OGD Awards Committee.
- Represented OGD at the CDER SharePoint Board, and communicated issues, and changes.
- Facilitated final issuance of final decisions across offices in CDER.
- Developed requirements, created, tested, implemented and monitored an electronic automated Carpe Diem Awards system to recognize OGD Staff.
- Mentored and trained OGD Staff to leverage SharePoint for managing projects.
- Created >50 SharePoint sites, >100 SP site pages, >100 libraries.
- Created site architecture in SharePoint (8-10 sites) to leverage permissions, topics, owners and compartmentalize information when necessary for OGD.
- Developed requirements, created, tested, implemented and managed an electronic SharePoint Request Tool for OGD staff, to track turn around times, assignment and completion.
- Created, coordinated review and finalization Standard Operating Procedures, Work Instructions, forms (paper & electronic), and Internal OGD Manual of Policies & Procedures (MAPPs).
- Level II FAC-P/PM and Level III FAC-COR
- Delivered exceptional customer satisfaction by proactively addressing client concerns and meeting or exceeding expectations throughout the engagement process.
- Established effective communication among team members for enhanced collaboration and successful project completion.
- Coordinated with cross-functional teams to resolve project issues and mitigate risks.
- Monitored project performance to identify areas of improvement and make adjustments.
- Negotiated and managed third-party contracts related to project deliverables, includes statement of work (SOW), deliverables, and independent government cost estimates.
- Enhanced overall project success by conducting thorough post-project evaluations and incorporating lessons learned into future efforts.
Sr. Regulatory Health Project Manager
Federal Drug Administration (FDA), Center for Tobacco Products (CTP)
03.2012 - 03.2020
- Performed strategic planning, scheduled and facilitated meetings, prepared issue-based agendas and official records of meetings with internal and external customers.
- Served as a contact point for communications concerning tobacco product applications and other submissions, ensuring compliance with all legal, regulatory and policy requirements.
- Worked to resolve any conflicts on projects, and ensure timely completion of activities and objectives.
- Demonstrated independent initiative and judgment in problem solving and effectively planning, managing, facilitating and completing assigned projects.
- Drew upon knowledge of the Food, Drug and Cosmetic Act, regulations and policies.
- Mentored and trained junior-level staff regarding FDA/CTP policies and procedures applicable to the regulation of tobacco products.
- Center for Disease Control (CDC) liaison for CTP, Office of Science and managed and facilitated Interagency Agreements.
- Effectively used databases, and computer software applications to accomplish work activities.
- Excellent organizational skills, oral and written communication skills.
- Excellent interpersonal relationship skills and ability to collaboratively lead teams in a cohesive environment.
- Coordinated cross-functional teams and resolved conflicts, maintaining a positive work environment throughout the tobacco application lifecycle.
- Implemented continuous improvement initiatives to optimize tobacco application management and outcomes while maintaining cost effectiveness.
Laboratory Technician II
Frederick Memorial Hospital
01.2012 - 05.2014
- Performed analysis under Joint Commission on Accreditation of Healthcare Organizations (JACHO) regulations.
- Read various types of Microbiology cultures, performed work-ups for identification, and reported results.
- Performed a variety of immunological assays and QC.
- Maintained instrumentation, interpreted results and worked independently.
- Performed testing and quality control using approved laboratory procedures and instrumentation.
- Contributed to a safe working environment by consistently following established safety procedures and guidelines within the lab setting.
Select Agent Manager
United States Army Medical Research Institute of Infectious Disease (USAMRIID)
03.2007 - 12.2011
- Prepared, updated, & managed Select Agent Registration for >40 Principal Investigators(PIs) in accordance with 7 CFR Part 331, 9 CFR Part 121, 42 CFR Part 73, AR 50-1 & AR 190-17
- Provided guidance and support to >500 staff in regards to the Select Agent Program (SAP)
- Prepared and managed interstate and import permits from US Department of Agriculture (USDA)
- Coordinated export licenses with the Department of Commerce(DOC) and import/export for CITIES compliance.
- Developed a training program & delivered training to >500 users to maintain regulatory compliance.
- Interfaced with CDC, and USDA for select agent registration.
- Prepared and coordinated inspections with external agencies.
- Created, updated and managed SOPs according to 42 CFR Part 73, 7 CFR Part 331, 9 CFR Part 121, AR 50-1, and AR 190-17.
- Developed and assisted with BSAT Inventory Audit Program in Bio-safety Levels 2, 3 and 4 to ensure regulatory compliance.
- Prepared, sent, tracked and managed shipping, BSAT transactions & registration documents.
- Certified in Biomedical Material transport.
- Participated in Biosurety Board meetings.
- Delivered exceptional customer service by proactively addressing concerns and fostering a positive experience throughout all interactions.
- Streamlined internal processes for improved efficiency and productivity within the agency.
- Consistently met compliance requirements for the agency by promptly completing mandatory continuing education courses and staying current on industry regulations.
Quality Assurance Specialist
National Biodefense Analysis Center (NBFAC)
09.2003 - 03.2007
- Created and Implemented Training Program to meet ISO 17025 requirements with over 100 Standard Operating Procedures (SOPs), Work Instructions (WIs), with >50 personnel.
- Prepared presentations and participated in Management Reviews for ISO 17025.
- Assisted with Corrective Action, Preventative actions and root cause investigations.
- Administrator of equationASP by Prism eSolutions, assisted with design, beta testing and implementation of Laboratory Information Management System (LIMS) documentation database and MIDEO photo documentation system.
- Provided microbiological support for set-up, interpretation and identification of bacterial cultures for biological threat agents using classical and automated methods.
- Performed molecular analysis and ELISA testing on bioforensic samples.
- Permitted to ship forensic samples/Select Agents in accordance with IATA regulations.
- Competent in Biosafety levels 2 & 3 and provided training to newly assigned team members.
- Spearheaded team training initiatives, equipping staff with essential skills to excel in their roles.
Laboratory Technician
United States Army Medical Research Institute of Infectious Disease (USAMRIID)
08.1999 - 09.2003
- Document Control Manager, led team for implementation of SOPs, acted as liaison to the Quality Assurance Unit, distributed and maintained all operational SOPs.
- Authored over 50 new SOPs and revised older SOPs, assisted with A2LA accreditation.
- Performed tasks in Biosafety levels (BSL) 2 and 3, completed BSL-4 training.
- Received and processed environmental samples with completed chain of custody documentation.
- Performed identification of biological threat agents (BTA) using classical and automated methods, Electrochemiluminescence (ECL), ELISA and PCR testing of environmental samples.
- Evaluated and validated current and new diagnostic technologies for the isolation and identification of microbial organisms.
- Cultured and characterized over 100 strains of biological threat agents including Bacillus anthracis, Francisella tularensis, Yersinia pestis, Burkholderia mallei, Burkholderia pseudomallei.
- Operated basic laboratory equipment such as balances, pH meter, colorimeter, spectrophotometer, autoclave and evaporator.
- Documented information by maintaining daily logs and equipment record books.
Laboratory Technician II
Frederick Memorial Hospital
05.1998 - 08.2004
- Performed analysis under Joint Commission on Accreditation of Healthcare Organizations (JACHO) regulations.
- Duties included phlebotomy, reporting results for the following: chemical analysis of serum, plasma, urine, CSF, and various other body fluids; performing pH analysis, osmolality, urine toxicology, thyroid profiles, and viral hepatitis testing.
- Maintained instrumentation, interpreted results and worked independently.
- Maintained a high level of accuracy in test results by following strict quality control procedures.
Medical Laboratory Journeyman
United States Air Force
06.1994 - 03.1998
- Maintained daily, weekly, monthly, and annual Quality Control in USAF medical lab.
- Wrote and implemented new procedures in Microbiology and Blood Banking.
- Performed ABO/RH, antibody detection, cross match, and issuance of blood and blood products.
- Responsible for FDA, AABB & CAP inspections for Blood Banking.
- Performed analysis in Microbiology, Chemistry, Urinalysis, Hematology and Blood Banking.
Education
MC Project Management - Project Managment
The George Washington University
District Of Columbia01.2016
Master of Science -
National Graduate School
Boston, MA05.2009
BS in Applied Science and Technology - Clinical Laboratory Science
Thomas Edison State College
Trenton01.2008
Certified Medical Laboratory Technician - undefined
American Society of Clinical Pathology
01.1997
Associate in Applied Science - undefined
Community College of the Air Force
01.1996
Medical Laboratory Specialist - undefined
82nd Medical Training Group, USAF
01.1994
Apprentice Medical Laboratory Specialist -
82nd Medical Training Group, USAF
01.1993
Skills
- Critical thinking
- Problem solving
- Leadership
- Communication
- Microsoft Office/Smartsheets
- Active listening
- Adaptability
- Organization
- Trainability
- Project management
- Project planning and development
- Customer relations
Timeline
Project Manager
Federal Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD)
03.2020 - 07.2025
Sr. Regulatory Health Project Manager
Federal Drug Administration (FDA), Center for Tobacco Products (CTP)
03.2012 - 03.2020
Laboratory Technician II
Frederick Memorial Hospital
01.2012 - 05.2014
Select Agent Manager
United States Army Medical Research Institute of Infectious Disease (USAMRIID)
03.2007 - 12.2011
Quality Assurance Specialist
National Biodefense Analysis Center (NBFAC)
09.2003 - 03.2007
Laboratory Technician
United States Army Medical Research Institute of Infectious Disease (USAMRIID)
08.1999 - 09.2003
Laboratory Technician II
Frederick Memorial Hospital
05.1998 - 08.2004
Medical Laboratory Journeyman
United States Air Force
06.1994 - 03.1998
Certified Medical Laboratory Technician - undefined
American Society of Clinical Pathology
Associate in Applied Science - undefined
Community College of the Air Force
Medical Laboratory Specialist - undefined
82nd Medical Training Group, USAF
MC Project Management - Project Managment
The George Washington University
Master of Science -
National Graduate School
BS in Applied Science and Technology - Clinical Laboratory Science
Thomas Edison State College
Apprentice Medical Laboratory Specialist -
82nd Medical Training Group, USAF
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