Engineering Development

CHRISTOPHER GAUGHAN

Union City, CA ***** 732-***-**** ***********@*****.***

CELL AND PROTEIN PRODUCTION: BIOREACTOR SPECIALIST

Bench Scientist experienced with in-depth purification and detailed characterization of recombinant proteins and monoclonal antibodies. Valuable contributions to protein engineering, industrial applications of chromatography, fluorescent and bioluminescence imaging, immunologic assays for investigation of cell surface entities, and the fabrication, scale-up and validation of protein chemistry on engineered conjugates with targeted cross linking. Pioneer of processes that expedite go-to-market timelines, achieve cost savings, and result in extensive business development opportunities. Excellent interpersonal and communication skills leveraged to manage efficient, compliant lab environments and a work ethic that ensures project completion to high quality standards within critical timeframes.

Areas of Expertise

Research and Development:

Expression of Recombinant Proteins in Multiple Vectors, Mammalian Cell Transfection, Immunoglobulin modification (ADC), Cell Culture, Resolution Of Complex Protein Lysates, Protein Chemistry, Fluorescent imaging, Tissue Homogenization, Western Blotting

Downstream Manufacturing:

Chromatography Packing/ Selection, Bioreactor Operation, Serum-Free Growth, Bioassay Development and Validation, Monoclonal Antibody Platforms, kLa sensors

Upstream/Downstream Methods Development:

Chromatography: Gel Filtration (SEC)/IMAC, Protein A,G/IEX/HIC/ÄKTA FPLC, PCR, qPCR, ELISA Development/Optimization, prototyping, ICH validation of process development

Quality Control:

Protein Lyophilization and Stability Testing, Maintenance and testing of Enzyme Activity after Procedural Operations (e.g. Concentration/ Chemical Modification)

Analysis and Reporting:

Root Cause Analysis, Statistical Analysis, Technical Writing, Peer-Reviewed Publication, Reviewer of manuscripts, Quality Assessment

Laboratory Management:

Process Optimization, Risk Management, Cost Savings Initiatives, Project Leadership, Technician Supervision, Six Sigma Methodologies

Professional Experience

INDEPENDENT RESEARCH CONSULTANT, San Francisco, CA & NJ 7/2015 – Present

Consultant

Partner with scientists and researchers to devise strategies for risk management, statistical analysis in line with clients’ goals, requirements, and limitations. Leverage diverse research experience to develop unique and comprehensive processes, guidelines, and programs that facilitate research accuracy, particularly related to protein production and cell expansion. Experienced in bioreactor design, manufacture and use.

Key Achievements:

Delivered >$15K in cost savings to a start-up by validating the fill volume of monoclonal antibody vials as a function of solution viscosity/concentration.

Facilitated the design of next-generation anchorage-dependent cell bioreactors by identifying parameters affecting scaffolds seeded with stem and primary cells for expansion in an experimental bioreactor format. Developed means for pO2 detection to optimize cell growth.

Achieved bioreactor scale-up with improved mixing resulting in higher yield of cultured mammalian cells.

ZYMERA, INC., San Jose, CA 10/2012 – 7/2015

Staff Scientist

Designed and executed enzyme expression and purification in line with company objectives by leading project planning, developing Standard Operating Procedures (SOPs), and authoring technical reports. Managed the performance training of a lab technician to ensure accurate execution of research and laboratory procedures. Developed data visualization models and related collateral to present results to the executive team.

Key Achievements:

Cut $25k per gene in annual licensing fees by collaborating with the CMO to produce ip-free expression vectors.

Increased throughput and expedited time-to-market for Respiratory Syncytial Virus Vaccine through validation of the ultra-sensitive, automated ELISA viral plaque counting system.

ZYMERA, INC., Key Achievements, continued:

Facilitated the creation of a new product line by developing multi-protein-complex nanoparticle imaging probe to target cell surface markers in human cells and enable deep tissue penetration.

Grew the company’s enzyme portfolio by producing and scaling up recombinant protein/antibody production from bench scale to bioreactor format to produce proprietary light-producing enzymes.

Enhanced flow-through and output of product while reducing support staff workload through the implementation of an improved protein purification schema.

MEDIMMUNE/ZYMERA INC., Mountain View, CA 10/2011 – 10/2012

National Science Institute Industrial Post-Doctoral Fellow

Selected for a post-doctoral fellowship at this cGMP-compliant facility to enhance vaccine production by strategizing and executing initial validation of an experimental, ultra-sensitive, high-throughput assay used in viral infection detection in VERO cells.

Key Achievement:

Increased throughput of vaccine development by collaboration cross-functionally on the troubleshooting and validation of a plaque-counting assay to increase throughput during vaccine development.

3D BIOTEK, North Brunswick, NJ 9/2010 – 9/2011

Senior Scientist (Contract)

Led a cross-functional, multi-disciplinary team in the development of new biomimetic coatings for anchorage-dependent cell growth.

Key Achievements:

Achieved adherence and growth of mammalian cells in a serum-free medium by via validation of biomimetic coating coverage on polypropylene scaffolds, meeting FDA regulations for cell growth.

Recognized as a resource and mentor to demonstrate techniques and provide scientific explanations of principles behind assays and other techniques for laboratory technicians and research personnel.

RUTGERS BIOMEDICAL ENGINEERING HPLC OPTIMIZATION, Piscataway, NJ 1/2008 – 1/2010

Visiting Scientist

Planned, directed, and executed research of skin reactions to various irritants by developing protocols for HPLC separations of small molecules/peptides in reverse phase C-18 and performing process verification on HPLC protocol.

Key Achievements:

Optimized HPLC separations via iterative testing and assessment to eliminate ghost-peaks, improve peak sharpening and separation, resolve crude antibody mixtures, and identify and address critical quality attributes.

Education & Credentials

Ph.D. in Chemical and Biomedical Engineering, RUTGERS UNIVERSITY New Brunswick, NJ

Thesis: Design and Fabrication of a Self-Assembling Hydrogel for use as a Tissue Engineering Scaffold

Designed genes, expressed and purified self-assembling proteins with tailored properties to manufacture a hydrogel-based tissue-engineering scaffold for spinal cord regeneration.

Simulated aggregation of 28 amino acid alpha helices for the thermodynamic study of theoretical protein-protein aggregation.

Bachelor of Science in Chemistry, Magna cum Laude SUNY UNIVERSITY AT ALBANY Albany, NY

Member, American Institute of Chemical Engineers

ASQ cGMP Certification: Will Take Exam February 2017

Recent Publications & Contributions

Gaughan, Christopher L. "The present state of the art in expression, production and characterization of monoclonal antibodies." Molecular diversity (2015): 1-16. DOI 10.1007/s11030-015-9625-z.

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