Nastassia C. Folkes
St Cloud,FL
Summary
Highly productive and efficient Senior Scientist and Validation Engineer with expertise in biotechnological techniques, data analysis, and experimental design. Recognized for exceptional critical thinking, problem-solving, and collaboration skills. Achieved success in process development initiatives and team projects.
Overview
12
12
years of professional experience
Work History
LEAD SENIOR PROCESS VALIDATION ENGINEER-PROCESS VALIDATION
PFIZER - OXFORD GLOBAL RESOURCES INC
Rocky Mount, NC
04.2023 - Current
- Lead team of 30+ Engineers in major process validation project (validation of new automated manufacturing facility, five new filling lines and new process validations processes for all products made at the site)
- Subject matter expert for Process Validation activities (commercial aseptic and terminally sterilized Solid Volume Parenteral drug products)
- Provide technical support to manufacturing and quality department for drug product questions (investigations, technical)
- Generate, review and execute PV Protocols, Batch records, data sheets and other GMP documents related to the Validation and Release of commercial drug product batches for sale in multiple markets
- Oversee process validation operations, sampling, scheduling, and ordering and delegate responsibilities
- Implement, initiate and oversee Change Controls and CAPA's and deviations
- Work in close collaboration with regulatory, project management, manufacturing, quality control and quality assurance
PROCESS DEVELOPMENT SCIENTIST III- MSAT PROCESS VALIDATION
LONZA HOUSTON INC - OXFORD GLOBAL RESOURCES INC
12.2021 - 12.2022
- Subject matter expert for CMO Fill Finish and Aseptic Qualifications Programs for Cell & Gene Therapy and Viral Vector Drug Products
- MSAT Process Validation lead for multiple projects, established process parameters and specifications required for the Drug Product fill finish vialing and sealing process
- Managed projects BOM/SAP, SOW changes, timelines and schedules
- Authored technical assessments regarding specification changes for raw materials and implemented process CAPA's and Change Controls (Trackwise)
- Evaluated Vendor notification changes and proactively addressed risks and process issues
- Provide process oversight, analyzed, reviewed and presented key findings and process outputs to internal teams, external clients and company leadership
- Performed technical writing, document creation & review of cGMP Batch Records, deviations, SOP's, Validation Protocols (protocol and report generation, troubleshooting equipment issues)
- Participated in regulatory filling readiness and Audit responses from external clients and FDA
- Assist with CAPEX regarding the Facility and Filler/Sealer equipment enhancements
SENIOR SCIENTIST- UPSTREAM PROCESS DEVELOPMENT
AGC BIOLOGICS INC OXFORD GLOBAL RESOURCES
11.2019 - 11.2021
- Upstream Lead for CMO working with clients to design and optimize CHO cell culture processes and bioreactor operations
- Manage processing timelines, interpret data, provide client updates
- Execute characterization and DOE studies for CHO mammalian cell lines from culture through bioreactor harvest (Stir Tank 2000L, Profusion, Amber 250)
- Optimization of growth media, and production parameters for stable cell lines
- Design experiments, developed scale up strategies, and collaborate with internal teams to improve cell growth and titer (use metabolic data to improve batch and feed media strategies)
- Analyzed and interpreted Process Development and Manufacturing data in order to implement process changes, trended analytical data (JMP, Excel)
- Performed technical writing and review of Protocols and Summary Reports
- Reviewed and approved GMP manufacturing and compliance (Batch Records, Technical assessments & Validation Protocols)
- SME and Trainer on Amber 250 High throughput automated 24 vessel Bioreactor System
SCIENTIFIC & TECHNICAL OPERATIONS SCIENTIST I- PROCESS DEVELOPMENT
ADMA BIOLOGICS
10.2018 - 11.2019
- Subject Matter Expert for Plasma Fractionation/Purification commercial manufacturing process for plasma derived products
- Execute upstream and purification studies (formulation, filtration, UF/DF, Chromatography) and perform analytical lab testing (spectroscopy, pH)
- Author and review regulatory and CMC documentation for GMP products BLA/IND filling and technical literature
- Lead deviation investigations and implemented CAPA's and corrective actions for manufacturing processes
- Author process Risk Assessments and Criticality Reports based on process CMC and report
- Perform review of Extractables and Leachable quality testing and generate internal reports
- Evaluated and analyzed process data, parameters, results and executed documents
ASSOCIATE SCIENTIST-PROCESS DEVELOPMENT, MSAT, MANUFACTURING
GOODWIN BIOTECHNOLOGY INC.
10.2012 - 11.2017
- Author and execute Process Development Cell culture & Media Optimization, DOE and Characterization studies (CHO, Hybridoma, Melanoma cells)
- Perform small scale Bioreactor upstream operations (up to 200L, Stir tank and Profusion harvest of monoclonal antibodies and recombinant protein)
- Perform downstream processing operations (Protein A purification, Titer analysis)
- Investigated process deviations and generated CAPA's and change controls for process improvements
- Project Management and CMO Subject matter expert for Process Development Cell Culture projects, worked closely with external clients and cross functional teams to drive timelines
- Track and trend data in laboratory notebook and databases
- Support the technical transfer of manufacturing process from development to scale up and commercial manufacturing
- Technical writing of GMP SOP's, batch records, summary reports, deviations for executed studies/batches
- Supervised commercial large scale media prep team and Aseptic filling qualification training
Education
MASTER OF BUSINESS ADMINISTRATION - International Business
BARRY UNIVERSITY
05.2021
MASTER OF SCIENCE - Medical Biotechnology
BARRY UNIVERSITY
06.2018
BACHELOR OF SCIENCE - Biology,Chemistry
BETHUNE-COOKMAN UNIVERSITY
06.2011
Skills
- Drug Product Development
- Bioreactor Operation Experience
- Client-Facing CDMO Expert
- Effective Problem-Solving Skills
- Project Coordination and CRM Proficiency
- Expertise in cGMP Testing and Release
- GMP and Aseptic Technique Expertise
- Risk Management Expertise
- Extensive Technical Writing
- Regulatory Filing Experience
- Strong Communication Skills
- Deadline-Driven Project Execution
- Collaborative Team Leadership Experience
- Systems experience (GLIMS, SAP, Trackwise, JMP, QMS, Vault, Ariba, MCD, MSB, PDOCS)
- Process Validation
- GMP compliance
- Process Validation
- Process Improvement
- Risk Assessment
Timeline
LEAD SENIOR PROCESS VALIDATION ENGINEER-PROCESS VALIDATION
PFIZER - OXFORD GLOBAL RESOURCES INC
04.2023 - Current
PROCESS DEVELOPMENT SCIENTIST III- MSAT PROCESS VALIDATION
LONZA HOUSTON INC - OXFORD GLOBAL RESOURCES INC
12.2021 - 12.2022
SENIOR SCIENTIST- UPSTREAM PROCESS DEVELOPMENT
AGC BIOLOGICS INC OXFORD GLOBAL RESOURCES
11.2019 - 11.2021
SCIENTIFIC & TECHNICAL OPERATIONS SCIENTIST I- PROCESS DEVELOPMENT
ADMA BIOLOGICS
10.2018 - 11.2019
ASSOCIATE SCIENTIST-PROCESS DEVELOPMENT, MSAT, MANUFACTURING
GOODWIN BIOTECHNOLOGY INC.
10.2012 - 11.2017
MASTER OF BUSINESS ADMINISTRATION - International Business
BARRY UNIVERSITY
MASTER OF SCIENCE - Medical Biotechnology
BARRY UNIVERSITY
BACHELOR OF SCIENCE - Biology,Chemistry
BETHUNE-COOKMAN UNIVERSITY
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