Bioprocess Engineer: Upstream Process Development, Conceptual Design, Manufacturing, Technology Transfer

Highly motivated individual possessing time management, problem solving & effectual decision making capabilities.  Successful cross‑functional team member, project lead & innovative contributor with Process Engineering, cGMP and pilot scale cell culture experience supporting development through technology transfer in clinical and commercial manufacturing of both recombinant proteins and cell therapies.  

SELECTED ACCOMPLISHMENTS:

  • Developed & implemented a novel flexible cell culture manufacturing process that increased productivity up to 4x, reduced culture duration by 60%, reduced cost per gram 70% & alleviated cell age impacts for robust performance & product quality; patent application submitted
  • Cell culture subject matter expert for facility fit, design considerations & potential future process capability for single-use production plant for both recombinant proteins & new modalities
  • Cell culture subject matter expert supporting process development & technology transfer of 2 phase III molecules
  • Manufacturing campaign support including Phase I, Phase III, PPQ & commercial support both internally & with CMO
  • Author to cell culture validation protocols & reports for 2 late stage molecules
  • Subject matter expert of novel high throughput robotic system for cell culture. Created novel in process assays, innovative online pH control of Tubespin reactors & contributed to peer reviewed publication
  • Managed clinical dose preparation technical support at 7 clinical sites for stem cell derived oligodendrocyte progenitor cell therapy drug product. Successful treatment of acute spinal cord injury in 5 human subjects
  • Created novel separation procedure for downstream processing unit operation in pilot & cGMP cell therapy manufacturing

 WORK EXPERIENCE:

    Principle Research Associate - Cell Culture & Bioprocess Operations (2020- Present)

  • Cell culture SME for facility fit & design considerations for Single Use Technology (SUT)
  • Led bioreactor equipment considerations: reviewed P&IDs & vendor packages, authored User Requirements (URS), defined acceptance criteria & testing requirements for commissioning & qualification
  • Upstream process considerations for Criticality Assessments (CA), automation & operational readiness
  • Author on User Requirements Brief (URB), led consumables, reagents & equipment to support basis of facility design for new modalities suite in single-use production plant

    • Senior Research Associate - Late Stage Cell Culture (2016- 2020)

  • Designed, tested & implemented novel upstream cell culture process in pilot plant & GMP for Phase I molecule. Increased productivity 2-4x, reduced culture duration by 60%, reduced cost per gram 70%, & alleviated cell age impacts for robust performance & product quality; patent application submitted. Process became new platform for global process development organization. Delivered future process capability for Roche manufacturing network.
  • SME for Phase III cell culture process development from clone selection to manufacturing stage
  • SME for Phase III technology transfer from Roche Germany development to SSF manufacturing
  • Author to cell culture validation protocols & reports for 2 late stage molecules
  • SME for campaign support for commercial production in SSF manufacturing

    • Senior Research Associate - Global Manufacturing Sciences & Technology (2014 - 2016)

  • SME for technology transfer of commercial process to CMO, on-floor support & troubleshooting & contributed to PAS
  • Facilitated risk management & gap analysis, authored report for Process Hazard Analysis (PHA)
  • Facilitated scale down studies with vendor to assess filter sizing for CMO’s equipment
  • Supported the removal of depth filtration from the upstream process, resulting in a more robust process & alignment with Roche manufacturing network. Required execution of stability studies & ensured timely, successful implementation for Engineering & Qualification runs at CMO

    • Research Associate - Late Stage Cell Culture (2012-2014)

  • Subject matter expert of novel high throughput robotic system for cell culture. Created novel in process assays, innovative online pH control of Tubespin reactors & contributed to peer reviewed publication
  • Application of engineering & cell culture expertise to design, perform, analyze, & document experiments on the high throughput system as well as at larger scales in R&D & Pilot Plant settings
  • Created JMP® statistical analysis scripts in order to provide collaborators with real time data analysis of large data sets for high throughput robotic experiments
  • Led improvements in sample handling, robotic movements & wrote complex robotic methods to improve processing time 20-60%
  • Developed & optimized 2 novel metabolite assays & cell count & viability analysis methods for compatibility with high throughput environment
  • Increased throughput of metabolite assays by 33% by development of combined 384 well plate based assay conditions

    Process Engineer – Manufacturing Sciences, Product Development (2011 – 2012)

  • Member product development engineering team, responsible for technical proficiency of uhESC derived cellular drug product preparation in a Phase I Clinical Trial & animal studies, upstream & downstream process development, manufacturing & technology transfer
  • Responsible for technology transfer, protocol & documentation management, supply chain management of clinical grade material, troubleshooting & indirect management of 25 operators at 7 cross continental clinical sites
  • Corrective & Preventative Action (CAPA) & subject matter expert for drug product processing to collaborate between clinical site cell processing operators & Study Execution Team (SET) members for successful administration of drug product to patients
  • Created novel separation procedure, executed data analysis, supporting documentation, formal reports &performed technology transfer of downstream processing unit operation to Pilot Plant & GMP manufacturing personnel
  • Performed JMP® statistical analysis on multiple data sets to facilitate real time updates of production data to management, drive process changes in manufacturing, identify trends in production & reduce clinical dose preparation factor leading to inventory & supply chain stability of drug products
  • Led design of experiments (DOE) for end stage drug product filtration, resulted in optimized drug product, increased viable cell yield & streamlined quality/analytical methods for screening end stage product
  • Served as technical expert & author of training manuals, GLP & GMP protocols, interactive guides & presentations during training of personnel & technology transfer cross-departmentally in Geron & externally with line extension collaborators

    • Development Associate I - Manufacturing Sciences, Product Development (2009-2011)

  • Member of Pilot Plant team & manager of supply chain materials for pilot plant operations; specialized in cell culture, troubleshooting & optimization of uhESC manufacturing processes & end stage cellular drug products
  • Completed execution & planning production of large scale manufacturing of 2 pilot grade cellular drug products
  • Forecasted & managed Pilot Plant materials for manufacturing of 2 cellular drug products
  • Tracked & analyzed trends of NOVA BioProfile® data of cell culture nutrients & metabolites- led to the development of production decisions based on analysis of cell culture growth
  • Contributed to Lean Six Sigma time & motion studies to develop tools, placement of large equipment & refine processing techniques to improve ergonomics, decrease processing time & ultimately increase efficiency of operators by 25%
  • Designed experiments (DOE) to optimize: fill & finish procedures of cellular drug products, seeding density of cell cultures during differentiation & selection, operator use of improved container closures, custom biocontainer prototypes

    Research Assistant- Polyclonal Antibody Production (2007-2008)

  • Member of Polyclonal Antibody production team providing support for the purification & analysis of polyclonal antibodies

PROCESS ENGINEERING & MANUFACTURING

  • Data Tracking & Trending
  • Root Cause Analysis
  • Technical Writing
  • Process Flow Diagrams
  • P&ID Review
  • Criticality Assessments
  • Commissioning /Qualification
  • Ph1-3, PPQ , Commercial & Engineering Campaigns
  • Facility Fit/Gap Analysis
    • Technology Transfer
    • Bioreactor Scale Up(Pilot & GMP)
  • Mass Transfer/kLa
  • Batch Record Review
  • Filter Sizing
  • Validation Studies
  • Single Use Technology

LABORATORY

DIGITAL

  • Aseptic Technique
  • Mammalian Cell Culture (Flask, Tubespin, Ambr15 & 250, 2L & pilot scales)
  • High Throughput Robotics
  • Perfusion techniques
  • Assay development
  • Dose Preparation of Cell Therapy Drug Products
  • JMP® Design of Experiment
  • JMP® Data Analysis
  • JMP® Scripting
  • Biomek FXP & NXP scripting
  • HTML scripting

EDUCATIONAL EXPERIENCE:

B.S Nutritional Science, Minors: Biotechnology & Biology - California Polytechnic State University, San Luis Obispo CA       

Cal Poly Graduate Nutrition Lab - Protein purification & western blot analysis on rat cardiac, lung, & muscle cells in order to test the varied degree of transcription factor gene expression in young & aged cells

Senior Project “Effect of Docosahexaenoic Acid & Eicosapentaenoic Acid on Gene Expression & Regulation of Cellular Inflammatory Molecules”

 PROFESSIONAL DEVELOPMENT:

  • SAS/JMP® Engineering Statistics & Data Analysis, Design of Experiments using JMP® Software- Thomas A. Little Consulting
  • Cellular Bioprocess Technology- University of Minnesota
  • SAS/JMP® Modeling Multidimensional Data – SAS Institute Inc.
  • Berlitz German Language Level 1-2 classes

 PEER REVIEWED PUBLICATIONS:

AB Bos, JN Duque, S Bhakta, F Farahi, L Chirdon, JR Junutula, PD Harms, AW Wong (2014). Development of a semi-automated high throughput transient transfection system.  Journal of Biotechnology 180: 10-16. 

Lindsay Helmuth's Resume.pdf Lindsay Helmuth's Resume.pdf
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