999 Main Street • Any Town, NY 99999
999-999-9999 • firstname.lastname@example.org
Kenneth Johnson, Ph.D.
PROCESS DEVELOPMENT SCIENTIST
Management and Biochemical Engineering and Biotechnology
Mammalian Cell Culture and Microbial Fermentation
Recombinant Protein and Vaccine Production, Purification and Characterization
Bio Process Optimization, Scale-up and Tech-transfer
With advanced training and hands on experience on mammalian cell culture, recombinant protein and vaccine production, purification and characterization from bacterial, yeast and mammalian expression systems, experienced, enthusiastic and adaptive process development scientist offers superior bioprocess development, scale up and optimization skills, combined with commitment to conducting research on biotechnology and biopharmaceuticals.
AREAS OF EXPERTISE
- GMP, GLP, and ISO Guidelines, BSL-2 and BSL-3 Trainings
- Design of Experiments (DOE)
- Process Modeling, Monitoring & Statistical Data Analysis Using SAS – JMP 7.0
- Process Optimization, Scale-up, and Validation Studies for Biomanufacturing of Phase I-III Products, including Vaccines, Cell Therapeutics and Proteins
- Mammalian Cell Culture, Cell Transfection and Microbial Fermentation
- Batch and Fed-Batch Stirred Tank Bioreactor Operation and Troubleshooting
- Cell-based Assays for Critical Product Quality Attributes (Alamar Blue and Trypan Blue Stainings for Cell Viability, Hemacytometer and Cedex / Flex Cell Counters for Total Cell Count, Immunofluorescence Assay (IFA) for Vaccine Titer)
- Membrane Filtrations (Ultrafiltration, Diafiltration and Tangential Flow Filtration)
- Protein Analysis and Characterization (HPLC – Agilent 1200 Series with Chem Station, SDS-PAGE, Blue Staining and Silver Staining, Western Blot, ELISA, UV-vis Spectrophotometry, Densitometry Analysis)
- Documentation Systems (Lab Notebooks, SOPs, BPRs, Process Validation, Quality Control, Technical Reports, Technology Transfer, Expense Budgets, Work Orders and Purchasing Systems)
Vice President Research and Development 08/2009 – 02/2010
ABC Inc. Any Town, NY
- Managed R&D budget of $12MM and directed 24 scientists.
- Responsible for the development of the Company’s product internal pipeline and intellectual property .
- Performed annual budgeting, including capital requirements, and implement monthly forecasting and reporting.
- Identified new business opportunities, performed market research, analyzed patent portfolios, and led due diligence activities and participate in M&A activities.
- Negotiated licensing and royalty agreements with pharmaceutical, biotechnology companies and universities.
- Lead and directed competitive intelligence surveillance program.
- Recruited Scientific Board of Advisors.
- Successful in hiring, motivating and retaining quality personnel.
Manufacturing Operations 03/2007 – 01/2009
XYZ Corp. Any Town, NY
- Managed microbial and yeast fermentation, cell culture, transgenic plant and combination drug and device manufacturing facilities. Senior executive and site manager for biotechnology manufacturing facility.
- Brought three manufacturing facilities into GMP compliance.
- Developed and implemented strategic business plans and Cost of Goods models.
- Led successful implementation of multiple technology transfer programs, internal and external.
- Directed facility start-ups from commissioning through validation into manufacturing.
- Led Contract Manufacturing Organizations.
SCIENTIFIC OFFICER 2002 – 2006
BCD Inc. Any Town, NY
- EMP sampling for monitoring of environment while working with culture in biological safety cabinet.
- Performed in-process sampling for wet weight analysis, microbiological control (checking for contamination by slide preparation and staining) and concentration of antigen produced during the process.
- Performed data entry into the WFERMAC software for record keeping and used data for the compilation of the BPR with tables and graphs.
- Developed and implemented Standard Operating Procedures (SOPs), protocols and maintained records and logbooks of all equipments as per current Good Manufacturing Practices (GMPs).
- Evaluated equipment status, solutions, materials and processes by reviewing the pertinent records and Monitored processes to identify opportunities for continuous improvement.
- Coordinated with Quality Control and Quality Assurance for deviations, change control, batch production records and campaign change.
- with equipment, such as Bio safety cabinets, CO2 incubators, Microscopes, pH meters, Autoclave.
Ph.D., CHEMICAL ENGINEERING, 12/2002 GPA: 3.75/4.0
University of California, Davis
B.Sc., CHEMICAL ENGINEERING, 06/1998 GPA: 3.75/4.0
University of Southern California