Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Languages
Work Preference
Timeline
Work Availability
79
Kenneth Blow

Kenneth Blow

Process Development
Towanda,PA

Summary

Accomplished scientist with extensive expertise in the development, implementation, and execution of cGMP and GLP processes. Successfully led multiple projects resulting in significant advancements in biotechnology. Demonstrated proficiency in laboratory practices, manufacturing sciences, process modeling, statistical analysis; process validation, and technology transfer.

Overview

7
7
years of professional experience
2
2
Certification

Work History

Manager Scientist

Sanofi
01.2023 - 05.2023
  • Collaborated closely with R&D to ensure processes for new vaccines are as innovative and standardized as possible to guarantee efficacy, cost-effectiveness, and rapid time to market for quality vaccines
  • Provided expertise in process development, manufacturing sciences, process modeling, statistical analysis, process validation, and technology transfer
  • Developed and improved cell culture strategies and approaches to increase the yield of recombinant antigens
  • Cultured and infected cells with targeted virus strains
  • Harvested proteins after reaching an appropriate viable cell density (VCD) which was monitored using Vi-CELL Blu and Vi-CELL XR instrumentation
  • Weekly processes involved 3L and 15L transparent jacketed Eppendorf bioreactors
  • Centrifuged and analyzed rHA using sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE)
  • Presented data biweekly; conducted root cause analyses (RCA) to explain variability (if any)
  • Installed and commissioned a new series of remote-controlled bioreactors
  • Managed projects including chiller unit temperature control optimization, volumetric oxygen transfer coefficient (kLa) determination, and oxygen transfer rate (OTR) determination

Gene Therapy Associate

Catalent
01.2022 - 01.2023
  • Served as an upstream SME antibiotic production
  • Modified batch records and drafted Standard Operating Procedures (SOPs)
  • Trained operations personnel on new installations and manufacturing processes
  • Resolved production upsets through equipment troubleshooting

Manufacturing Associate II

AstraZeneca
08.2021 - 01.2022
  • Worked in Central Services to support upstream and downstream large-scale manufacturing
  • Autoclaved equipment, prepared buffer solutions, and analytically weighed raw materials
  • Gained experience with business systems including Symphony, PAS-X, SAP, and Trackwise

Manufacturing Associate II

Lonza Group
06.2021 - 08.2021
  • Supported the downstream manufacturing department with endotoxin production
  • Filled and crimped vials with finished product in a cleanroom environment
  • Labeled vials, inspected products for defects, and packaged finished goods for shipping

COVID–19 pandemic layoff

05.2020 - 06.2021
  • Relocated out-of-state to transfer from automotive to biopharmaceutical manufacturing

Engineering Technician II

Corning Incorporated
06.2018 - 05.2020
  • Ensured upstream manufacturing stability during the raw material batching process
  • Managed upstream projects while conducting manufacturing experiments and reporting data
  • Collaborated with Environmental, Health, and Safety (EHS), and Quality departments to ensure compliance with internal and federal regulations; conducted EHS risk assessments, RCAs, and completed corrective and preventative actions (CAPAs) as the raw materials equipment owner
  • Identified and applied upper and lower control limits to mitigate variances in batch weight caused by automated scales
  • Drafted SOPs and trained operations personnel

Pharmacy Technician

CVS Pharmacy
08.2016 - 06.2018
  • Filled medication prescriptions under the supervision of a pharmacist
  • Filtered and translated incoming prescription requests from physicians
  • Communicated with insurance companies as needed to resolve prescription coverage issues

Education

Bachelor of Science - Biology

Louisiana State University
Baton Rouge, LA

Bachelor of Science - Chemistry

Mansfield University of Pennsylvania
Mansfield, PA
05-2013

Skills

  • Team Leader and Subject Matter Expert (SME)
  • Regulatory Compliance; FDA Audit History
  • Qualified Trainer for Aseptic Processes
  • Process Development and Project Management
  • Problem-Solving and Equipment Troubleshooting
  • Root Cause Analysis (RCA) and Risk Assessment
  • Safety Processes; ISO 45001 and ISO 9001
  • Good Laboratory Practice (GLP)
  • Current Good Manufacturing Practice (cGMP)
  • Communication; Soft Skills and Public Speaking
  • Scientific Principles and Methodology
  • Mathematics; Organization; Punctuality

Accomplishments

  • Collaborated with team of three manager scientists in the installation and commissioning of a $1,000,000 remote controllable Eppendorf bioreactor system; effectively doubling Sanofi's developmental capacity for Flublok and Fluzone.
  • Optimized temperature supply capabilities and minimized temperature distribution variability by rerouting glycol distribution pathways between chiller units and thermal jackets.
  • Optimized agitation capabilities by identifying appropriate impeller length, size, and style, and determined the volumetric oxygen transfer coefficients (kLa), and oxygen transfer rates (OTR) for 3L and 15L bioreactors. Successfully brought a section of the bioreactor system online during a scheduled audit with the Biomedical Advanced Research and Development Authority (BARDA), and simultaneously demonstrated bioreactor programmability and remote control capabilities to a team auditors while conducting kLa studies.
  • Collaborated with team of three Manufacturing Science and Technology (MS&T) engineers in the Installation and commissioning of a $250,000 300L New Brunswick Scientific fermentation system and developed supplemental media sterilization, inoculation, cultivation, harvest, and clarification processes.
  • Trained and supervised scientists and manufacturing specialists with GLP and GMP processes.

Certification

  • OSHA-30 Certification - Occupational Health and Safety Administration - March 2022
  • Six Sigma Yellow Belt Certification - Corning Incorporated - February 2020

Languages

English
Native or Bilingual
Spanish
Professional Working

Work Preference

Work Type

Full TimePart TimeContract Work

Location Preference

On-SiteRemoteHybrid

Important To Me

Career advancement

Timeline

Manager Scientist

Sanofi
01.2023 - 05.2023

Gene Therapy Associate

Catalent
01.2022 - 01.2023

Manufacturing Associate II

AstraZeneca
08.2021 - 01.2022

Manufacturing Associate II

Lonza Group
06.2021 - 08.2021

COVID–19 pandemic layoff

05.2020 - 06.2021

Engineering Technician II

Corning Incorporated
06.2018 - 05.2020

Pharmacy Technician

CVS Pharmacy
08.2016 - 06.2018

Bachelor of Science - Biology

Louisiana State University

Bachelor of Science - Chemistry

Mansfield University of Pennsylvania

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Kenneth BlowProcess Development