Stacy Simon
Frederick,MD
Summary
Accomplished Assistant Director combines cross-functional competencies in operations planning, customer retention and financial management to develop and coach staff while interfacing with executives. Expert in boosting revenue, quality and performance. Successful in executing standard operating procedures to positively impact organizational goals.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Associate Director – Manufacturing Sciences & Technology
AstraZeneca
Frederick, MD
08.2022 - Current
- Directing and overseeing a multidisciplinary team of researchers in a laboratory setting to facilitate continuous biologics manufacturing (drug substance) by conducting in-depth raw material screening, executing investigative procedures, small-scale drug substance manufacturing, and spearheading innovative advancements.
- Implementing transformative initiatives within the laboratory to facilitate a three-fold increase in experimental studies and operational outputs. This includes physical changes in the lab as well as digital solutions and simplifications.
- Providing essential support for yield investigations, with direct applicability to large-scale manufacturing processes.
- Conducting studies for the implementation of new products within the manufacturing operational framework.
- Satellite studies in small-scale bioreactors to support technology transfer.
- Technology transfer in both a sending unit and receiving unit capacity for small-scale bioreactor production models.
- Facilitating early talent development within AZ by mentoring two Global Graduate students, supervising multiple interns, and overseeing one co-op placement.
- Attainment of green lab status for MS&T labs, conferred by the My Green Lab global non-profit, and successful participation in the Freezer Challenge competition.
- Enhancing manufacturing training capabilities by developing and deploying protocols for precise sample handling techniques, and comprehensive pipette training.
- Development of augmented and virtual reality training programs for instrumentation and techniques for company-wide usage.
- Driving the implementation of new process analytics technology to achieve AZ Ops 2030 smart factory goals, including inline and offline spectroscopy, automated sampling capabilities, and improved analytical testing for cell culture process monitoring.
- End-to-end small-scale manufacturing of drug substances in small-scale three-liter bioreactor units, and AMBR250 bioreactor units.
- Implementation of Raman spectroscopy, inline and online predictive modeling for small-scale bioreactors, initiated changes within the manufacturing place to add this capability.
- Deploying digital tools, including LabVoice, Kanbanize, Smartsheets, Genemod, TULIP, and ChemInv, for process optimization and data management purposes.
- Engaging in collaborative efforts with the Supply Chain team to establish secondary sourcing options for raw materials and consumables.
- Conducting pilot programs and integrating emerging technologies onto the manufacturing floor.
- Designing and leading a multi-million-dollar renovation project for all MS&T laboratories.
- Managing the budget—both operational and capital—for the laboratory.
Chief Executive Officer
#BARE, LLC
Hagerstown, MD
02.2020 - Current
- Developed the formulation and design of product lines, ensuring alignment with market trends and customer demands
- Managed the end-to-end product lifecycle, from concept to launch
- Oversee supply chain process, resource optimization, and logistics for cost-effective and timely delivery of products
- Direct financial operations, including budgeting and profitability
- Lead product launch initiatives by setting timelines, coordinating strategies, and managing resources to maximize market impact
Lead Project Manager & Senior Scientist – Global Technical Operations Analytical
AstraZeneca
Frederick, MD
07.2021 - 08.2022
- Directing a compact and diverse team to deliver project management and operational assistance for internal projects and analytical technology transfers, including both analytical (ATT) and process technology transfers.
- Project Manager for analytical method development and technical transfer for the COVID-19 vaccine program, for analytical methodology, and manufacturing upstream processes.
- Leading a team of project managers in analytical technical transfers for over 15 analytical methods to over 50 different Contract Manufacturing Organizations (CMOs), Contract Testing Labs (CTL), and AstraZeneca sites around the globe, working across language barriers and time zone differences.
- Overseeing new information systems programs and technology as the Project Manager, which includes the Critical Reagent Inventory Management System, GQCLIMs digital uplift, and the continuous improvement submission system.
- Project Manager for the electronic lab notebook (eLN) templates program, which included a multi-department rollout.
- Project Manager for instrument procurement, commissioning, and decommissioning for all Global Technical Operations labs, including the onboarding of over 50 new pieces of equipment, and the construction and qualification of a new vaccine lab.
- Executing and reviewing analytical method validation testing, and analytical technical transfers for various methods, such as electrophoresis, titer/protein concentration, and UV-Vis.
- Authored and reviewed global SOPs—a program designed to streamline QC testing across the AZ network.
- Consultant for Lean Labs for the Frederick Manufacturing Center – helping many different laboratories achieve a strategic design for optimized analytical testing.
- Managing and tracking operational expenses and capital expenses for all GTO-A purchases.
Bioanalytical Lab Associate Scientist II – Global Technical Operations Analytic
AstraZeneca
Frederick, MD
04.2020 - 07.2021
- Laboratory testing and method development (HPLC, electrophoresis, Immunoassay, DSC, UV-Vis, Compendia)
- Support device investigations and returns including auto-injectors and automatic pre-filled syringes
- Global Technical Operations Lean Champion Consultant
- Method Validation testing and analytical technical transfer
- Authored and reviewed Global SOPs
- Program Manager for analytical method development and technical transfer for the COVID-19 vaccine program
- Includes leading a team of project managers in ATT’s for over 15 analytical methods to over 50 different CMO’s, CTL’s and AZ sites around the globe
Bioanalytical Lab Associate Scientist I – Global Technical Operations Analytic
AstraZeneca
Frederick, MD
09.2019 - 04.2020
- Laboratory testing and method optimization (HPLC, electrophoresis, Immunoassay)
- Support device investigations and returns including auto-injectors and automatic pre-filled syringes
- Global Technical Operations Lean Champion
- Method Validation testing and analytical technical transfer
- Project Manager for internal method validation and external analytical technical transfer for multiple products to multiple sites
Research and Development Associate II – Physicochemical Labs
AstraZeneca
Frederick, MD
09.2018 - 09.2019
- Analytical method development for novel drugs using technologies including: capillary gel electrophoresis, chromatography, reversed-phase chromatography, capillary isoelectric focusing, differential scanning calorimetry, and immunoassays
- Technical writing
- Presentation and explanation of findings
- Lead lab coordinator for six sigma and lab management team
Analytical Technology Associate II – Global Technical Operations Biophysical Lab
AstraZeneca
Frederick, MD
09.2018 - 09.2019
- Author protocols, SOPs and reports for analytical technical transfers
- Support team members with internal/external investigations
- Routine and platform testing (PAB, SoloVPE, Bioanalyzer, HPSEC, Compendia, Lateral Flow, Total Protein, RP-HPLC, TOC, Bioassay)
- Working with cell banks and on the Ready-to-Use cell project
- Implementation of new technologies
- Familiarity with Agilent and GE Sievers Technologies
- Have worked in both GMP and GLP regulated labs
- Protein chemistry experience
- Implementation of JIRA project tracking and ChemInventory systems
- Critical Reagents Qualification, maintenance, and shipping
Workstream/Project Coordinator – Global Technical Operations/Analytical
AstraZeneca
Frederick, MD
12.2015 - 09.2018
- Organize and lead project meetings and provide meeting agendas, and minutes
- Maintain and organize project documentation within SharePoint sites
- Facilitate document coordination from draft to approval
- Assign and drive completion of action items; maintain action, risk, decisions, and change logs
- Monitor and prepare upcoming schedule tasks and adhere to the project timelines
- Familiarity with GMP documents and procedures
- Review and author analytical technical transfer protocols
Education
B.S. - Biology
West Virginia University
Morgantown, WVM.S. - Biotechnology
Northeastern University
Boston, MAM.B.A - Master Business Administration
Maryville University
St. Louis, MOPhD - Biochemistry and Molecular Biology
University of Miami
Miami, FLSkills
- Hiring and training
- Key relationship development
- Recruiting, interviewing, and mentoring
- Public speaking
- Crisis management
- Professional networking
- Technical Transfer
- Cellular and Molecular Biology
- Spectroscopy
- Protein chemistry
- Critical thinking
- Database coordination
- MS office
- Collaboration
- Developing solutions to complex
- Data analysis
- People, project and program management
- Key relationship management
- Technical implementation
- Strategic leadership
- Work Planning and Prioritization
- Fiscal oversight
- Performance evaluations
- Product management
- Financial leadership
- Staff scheduling
- Diversity and inclusion initiatives
- Project management
- Verbal and written communication
Certification
- Notary Public, 01/01/21 - Present
- Learning Tree PMI Project Management Certification
References
References available upon request.
Timeline
Associate Director – Manufacturing Sciences & Technology
AstraZeneca
08.2022 - Current
Lead Project Manager & Senior Scientist – Global Technical Operations Analytical
AstraZeneca
07.2021 - 08.2022
Bioanalytical Lab Associate Scientist II – Global Technical Operations Analytic
AstraZeneca
04.2020 - 07.2021
Chief Executive Officer
#BARE, LLC
02.2020 - Current
Bioanalytical Lab Associate Scientist I – Global Technical Operations Analytic
AstraZeneca
09.2019 - 04.2020
Research and Development Associate II – Physicochemical Labs
AstraZeneca
09.2018 - 09.2019
Analytical Technology Associate II – Global Technical Operations Biophysical Lab
AstraZeneca
09.2018 - 09.2019
Workstream/Project Coordinator – Global Technical Operations/Analytical
AstraZeneca
12.2015 - 09.2018
- Notary Public, 01/01/21 - Present
- Learning Tree PMI Project Management Certification
B.S. - Biology
West Virginia University
M.S. - Biotechnology
Northeastern University
M.B.A - Master Business Administration
Maryville University
PhD - Biochemistry and Molecular Biology
University of Miami
Similar Profiles
Germaine HeinGermaine Hein
Senior Master Data Analyst (MDM) at AstraZenecaSenior Master Data Analyst (MDM) at AstraZeneca
MOHAMED HAMDYMOHAMED HAMDY
Medical Advisor, CVRM TA – New Launches at AstraZenecaMedical Advisor, CVRM TA – New Launches at AstraZeneca
Sreenivasan SSreenivasan S
Cluster Business Lead - South at AstraZenecaCluster Business Lead - South at AstraZeneca