Sneha Saggurthi
Burtonsville,MD
Summary
Highly motivated and skilled GxP professional with demonstrated experience in the biotech industry. Efficient at resolving challenging problems and driven to deliver exceptional outcomes to better the business as well as the community at hand.
Overview
12
12
years of professional experience
Work History
Lead Training Specialist
Catalent Pharma Solutions
01.2023 - Current
- Project Manager for buildout and launch of Maryland Training Center.
- Developed, tested, and implemented fast-track training programs to target business needs and CAPAs across various departments.
- Developed targeted training for appropriate cleanroom behavior, aseptic practices, and contamination control in alignment with business strategy.
- Technical subject matter expert (SME) in upstream and downstream manufacturing processes in addition to training for internal, client, and regulatory audits.
- Participated in 3 regulatory FDA audits including one PAI inspection. Provided site-wide training in preparation for audit.
- Monitored training data and effectiveness through metrics analysis and tracking KPIs. Developed training matrices for various departments.
- Facilitated learning through various adult learning principles including classroom instruction, on-the-job training, and instructor-led training.
- Lean Six Sigma Greenbelt
Training Specialist
Catalent Pharma Solutions
01.2022 - 12.2023
- Serviced 4 GMP production sites simultaneously which scoped about 1300 employees at given time.
- Provided onboarding and ongoing compliance, regulatory, and technical training across multiple departments.
- Participated in front-room and back-room activities for client and internal audits.
- Curricula and content creation and optimization in LMS to align with departmental and job-specific roles.
- Performed manufacturing activities to support upstream, downstream, and buffer prep activities when short-staffed for mammalian and microbial production.
- Continuous Improvement lead for 2 GMP production sites.
- Project Lead for Deviation Remediation project from Aug22-Jan23. Supervised 22 contractors on deviation workstream.
- White and Yellow Belt Certification
Manufacturing Associate III
Vigene Biosciences, A Charles River Company
09.2021 - 11.2021
- Qualified in Grade B Gowning.
- Supported GMP operations in upstream, downstream, and fill finish in grade B production areas for phase 1 manufacturing.
- Supported plasmid production in research-grade laboratory environment.
Manufacturing Associate II
Catalent Pharma Solutions
12.2020 - 09.2021
- Qualified Trainer.
- Allstream experience in both suspension and adherent cell lines for GMP commercial and clinical production.
- Allstream experience for fermentation and plasmid production.
Manufacturing Associate I
Catalent Pharma Solutions
11.2019 - 12.2020
- Performed upstream manufacturing activities for commercial production from thaw to TFF1.
- Participated in PAI Inspection
- Experienced in set-up and use of single-use bioreactor systems; including PALL iCELLis 500 units.
- Experience with Trackwise, Blue Mountain Regulatory Asset Manager (BMRAM), and creating and editing documents in EDMS.
Lab Assistant
Pediatric Psychology Lab At UMBC
08.2016 - 05.2017
Sterile Processing Department Tech
Medstar Georgetown University Hospital
06.2012 - 07.2015
Education
Bachelor of Science - Psychology
University of Maryland - Baltimore County
Baltimore, MD12.2018
Bachelor of Arts - Biology
University of Maryland - Baltimore County
Baltimore, MD12.2018
Skills
- Project Management
- Lean Six Sigma - Greenbelt
- Gene Therapy - AAV Production
- Contamination Control
- Adherent Cell Expansion
- Suspension Cell Expansion
- Microbial Fermentation
- Single-Use Bioreactor Systems
- Aseptic Techniques (Grade A-D)
- GMP, GLP, and GDP Knowledge and Implementation
- Quality Management Systems (Trackwise)
- Adult Learning Principles
- Training Needs Analysis
- Learning Management Systems (ComplianceWire and MasterControl)
Timeline
Lead Training Specialist
Catalent Pharma Solutions
01.2023 - Current
Training Specialist
Catalent Pharma Solutions
01.2022 - 12.2023
Manufacturing Associate III
Vigene Biosciences, A Charles River Company
09.2021 - 11.2021
Manufacturing Associate II
Catalent Pharma Solutions
12.2020 - 09.2021
Manufacturing Associate I
Catalent Pharma Solutions
11.2019 - 12.2020
Lab Assistant
Pediatric Psychology Lab At UMBC
08.2016 - 05.2017
Sterile Processing Department Tech
Medstar Georgetown University Hospital
06.2012 - 07.2015
Bachelor of Science - Psychology
University of Maryland - Baltimore County
Bachelor of Arts - Biology
University of Maryland - Baltimore County
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