Dikshya Upadhyaya
Rochester,MN
Summary
Results-driven Biochemist and Biomanufacturing Engineer with over 10 years of experience in fermentation technology and cGMP manufacturing. Expertise in CAR-T process development, master and working cell bank generation, and technology transfer from R&D to clinical manufacturing. Proficient in large-scale fermentation management, batch record development, and SOP authoring, ensuring adherence to FDA and ISO quality standards.
Overview
18
18
years of professional experience
Work History
Advanced Biomanufacturing Engineer III
Center for Regenerative Biotherapeutics
Rochester, MN
10.2023 - Current
- Support CAR-T therapy manufacturing on the CliniMACS Prodigy, including aseptic processing, cell expansion, transduction, and final formulation under cGMP.
- Led expansion of neonatal mesenchymal stem cells (MSC) and creation of Master Cell Bank (MCB) and Working Cell Bank (WCB), ensuring sterility, traceability, and regulatory compliance.
- Created and reviewed batch records, SOPs, and production documentation, supporting clinical-grade manufacturing and regulatory submissions.
- Conduct environmental monitoring (viable and non-viable) in cleanrooms to maintain ISO-classified conditions and product integrity.
- Collaborated with process development teams to streamline biomanufacturing workflows, ensuring smooth transfer of processes to manufacturing.
- Maintain and passage mammalian cell cultures, ensuring optimal growth and viability through strict aseptic technique.
- Participate in cross-functional initiatives to improve documentation systems, traceability, and GMP compliance.
- Mayo Clinic
Process Science Manager
Kerry
Rochester, MN
06.2023 - 10.2023
- Drove process improvements that increased fermentation yield and consistency across large-scale production.
- Led and developed team of scientists and technicians in fermentation and upstream process optimization to enhance performance.
- Partnered with R&D, QA, and manufacturing to ensure data integrity and adherence to global quality standards.
- Authored and reviewed technical protocols, risk assessments, and training materials to facilitate seamless process transfer.
Process Scientist
Kerry
Rochester, MN
07.2019 - 06.2023
- Supervised 30,000-gallon fermentation systems, enhancing process efficiency and shortening cycle time.
- Designed and executed process development and scale-up studies under cGMP for enzyme and culture manufacturing.
- Championed site for two product processes, achieving combined annual volume of ~2 million pounds.
- Delivered on-floor technical leadership and investigation support for deviations and CAPAs, ensuring compliance with quality standards.
- Developed and implemented data collection infrastructure for fermentation analytics and batch documentation.
Inoculation Lab Coordinator
Kerry
Rochester, MN
06.2017 - 06.2019
- Maintained culture collection of over 200 strains; optimized aseptic propagation and cryopreservation techniques to ensure strain viability.
- Isolated and optimized microbial strains to enhance product yield and consistency.
- Led root-cause investigations and implemented corrective actions using RCA and FMEA methods to address issues in microbial processes.
Fermentation Scientist
Elanco (a Division of Eli Lilly)
Gaithersburg, MD
01.2016 - 05.2017
- Optimized 30 L fermenters for enzyme production under cGMP, enhancing process efficiency.
- Conducted inoculation, harvest, and growth kinetics studies to enhance enzyme activity and increase cell biomass.
- Utilized Ambr250 mini bioreactor systems for fermentation optimization and media screening, streamlining experimental workflows.
- Prepared and maintained detailed batch records, run sheets, and process reports to ensure traceability.
Research Assistant
ARCTECH Inc.
Chantilly, VA
03.2008 - 07.2012
- Collaborated with U.S. Geological Survey on field study in Wyoming to assess bio-based remediation processes, advancing environmental restoration efforts.
- Optimized 1 L bioreactors, enhancing methane yield and facilitating technology transfer for pilot testing.
- Developed anaerobic microbial technology for biogas generation using novel microbial consortia, contributing to sustainable energy solutions.
Education
M.S. - Biotechnology
Johns Hopkins University
Baltimore, MD05-2015
M.S. - Energy Policy and Climate
Johns Hopkins University
Baltimore, MD05-2014
B.A. - Biochemistry
Hamline University
St. Paul, MN01-2008
Skills
- Cell & Gene Therapy Manufacturing
- CAR-T Cell Processing
- MSC Expansion & Banking
- CGMP Manufacturing
- Aseptic Techniques
- Process Optimization
- Design of Experiments (DoE)
- Process Scale-Up
- Technology Transfer
- Batch Record & SOP Creation
- Root Cause Analysis
- Quality & Compliance
- Protein & Enzyme Assays
- MFCS
- Agilent ChemStation
- JMP
- R
- Mathematica
- Windows
- Statistical Analysis
- Leadership
- Cross-functional collaboration
- Problem solving
- Process improvement
- Meticulous attention to detail
- SOFT
- TITLE21
Additional Information
Experienced in cGMP documentation, including Master Batch Record (MBR) development, review, and revision control., Strong cross-functional collaboration between Process Development, Quality, and Manufacturing teams., Calm, detail-oriented, and effective under pressure in regulated cleanroom and pilot-scale environments.
Awards
- Norma Johnson Scholarship
- 3M/Ronald Mitsch Scholarship (for excellence in Chemistry)
Timeline
Advanced Biomanufacturing Engineer III
Center for Regenerative Biotherapeutics
10.2023 - Current
Process Science Manager
Kerry
06.2023 - 10.2023
Process Scientist
Kerry
07.2019 - 06.2023
Inoculation Lab Coordinator
Kerry
06.2017 - 06.2019
Fermentation Scientist
Elanco (a Division of Eli Lilly)
01.2016 - 05.2017
Research Assistant
ARCTECH Inc.
03.2008 - 07.2012
M.S. - Biotechnology
Johns Hopkins University
M.S. - Energy Policy and Climate
Johns Hopkins University
B.A. - Biochemistry
Hamline University