Development Process
Resume:
MARY POULHAZAN
*************@*****.***
SUMMARY
I am an experienced cGMP fermentation and cell culture process development
scientist with hands on CHO, hybridoma, E. coli, and Saccharomyces
cerevisiae upstream expertise (an effective and innovative problem-solver
with manufacturing support experience with Pharma and IVD products from
single cell to 10 kL scale).
. Extensive cGMP documentation experience in MPD, BPD, SOP, Raw Material
Specification, development protocol and technical report writing using
ATLAS workflows. Familiarity with risk assessments, change controls,
deviations, CAPAs, FMEA and CPV quality initiatives.
. Leader/SME in fed-batch and continuous bioreactor and fermentor process
troubleshooting, operations and scale-up and technology transfer to
manufacturing of mammalian(up to 500 L) and microbial (up to 10 kL)
processes.
. Direct supervising and training experience; a consummate mentor.
Laboratory management and operations expertise.
. Leader/SME with stable strain selection, optimization, characterization,
expression assay development, validation and master and working cell
banks for pre-clinical and clinical products (QbD).
. Defined Media formulations (QbD), process, and assay development as well
as pre-clinical and clinical product manufacture.
. Experience managing development projects and cross functional groups
(including development, manufacturing and external partners).
. Leader/SME with analysis (JMP by SAS) and presentation of
metabolic/growth/productivity results to all scientific and management
levels.
EXPERIENCE
NOVARTIS, Emeryville, CA
2011- 2013 Consultant
. Leader in upstream and downstream investigation for E. coli expressed
product with internal and external partners. As SME made recommendations
to increase yield by 30-100%.
. Developed a novel defined media for Saccharomyces cerevisiae expressed
diagnostic antigens (QbD).
. Developed and established 1L fermentation model to assess development
efforts of microbial processes.
. As SME on multiple projects authored 50+ reports, SOP's, protocols, and
BPD's on multiple projects and participated with initial FMEA
evaluations, CPV and lifecycle approach.
. Supported analytical efforts to develop a quantitative SDS-PAGE assay for
insoluble recombinant protein.
SOLAZYME Inc., South San Francisco, CA 2009 - 2011
Consultant
. As fermentation SME for group, developed downstream recovery protocols
using existing continuous centrifuge and homogenization equipment that
reduced processing time by 33%.
. Developed formulations for algae based nutritionals. Supported
development efforts to define down-stream process for finished algae
flour that reduced contamination by 40%. Contributed analytical methods
necessary to characterize the process and product.
CELERA, Alameda, CA 2006 - 2009
Senior Scientist
. As SME developed and transferred to partner fed-batch fermentation
processes and cell bank for 11 recombinant enzymes based on original
shake flask model. Used JMP DOE to pre-validate CPP ranges.
. Designed and established a development cell culture facility and banking
system with related documentation for 85 cell lines. Prepared analyses
and presented to external collaborators.
CHIRON, Emeryville, CA 1992 - 2001
Development Specialist II (1997-2001)
. Developed a high density (200 OD) E. coli process that could fit the
constraints of a10 kL yeast fermentor by modeling at 10 L scale. Studies
accurately calculated the heat generation to within 10%.
. Invented process to prevent misincorporation of a non-natural amino acid
into recombinant protein.
. Managed key areas of transfer of E. coli fermentation process from a 10 L
to 10 kL manufacturing facility. Included development of a nutrient feed
strategy that reduced accumulation of toxic metabolic by-products. Wrote
transfer documents and trained manufacturing personnel.
. Designed an E. coli 10 L CO2 concentration model to study CO2
concentrations. Defined CO2 concentrations at which the 10 L and 10 kL
reactors could safely operate.
. Created inoculum build-up medium with GMP documentation and technology
transfer for Saccharomyces cerevisiae process at multiple scales.
Developed a quantitative SDS-PAGE assay for a recombinant protein
expressed in Saccharomyces cerevisiae.
Development Specialist I (1993-1997)
. Improved model for screening and selecting CHO (DG44) cell lines.
Strategies increased titers 25%-300%.
. Designed and built multiple CHO chemostats to model continuous culture
reactor and define operating conditions. Resulted in a more robust
manufacturing process at scale with narrower operating range.
. Adapted earlier hybridoma process to clone and select high producers that
increased titers 25%-50%.
. Authored/executed risk mitigation protocol for a 10 kL recombinant E.
coli process and manufacturing training sessions resulting 100% success
rate (no operator errors).
. Developed models for screening and selecting microbial cell lines that
increased titers 300%.
Development Associate I-III (1987-1993)
. Improved shake flask models for screening and selecting hybridoma cell
line by statistical nutritional analysis of cells/cultures. Resulted in
25-300% increase in titers for over a dozen cell lines.
. Using a QbD type approach redesigned cloning medium and selection
protocol to identify high producer that increased titers 25-50%
ADDITIONAL SKILLS
. Master's Thesis Advisor, Spring 2012 Fresno State University,
Professional Sciences - Biotechnology.
. Small-scale recovery of recombinant products from Insect cell, CHO,
hybridoma, Saccharomyces cerevisiae and E. coli fermentations.
. Excel, Word, PowerPoint, Project, and JMP (SAS) proficient.
. Fluent in French.
EDUCATION
BA, University of California at Davis, Bacteriology
San Francisco State University: Immunology and Medical Microbiology
(Biology Department), FACS Analysis (Graduate Clinical Sciences
Department), and Recombinant DNA Technology (Graduate Biology Department)
UC Berkeley Extension: Molecular Biology and Scientific Writing
University of Minnesota: Animal Cell Reactor Engineering
MIT: Fermentation Engineering
JMP Software: Statistical Data Exploration, ANNOVA and Regression, and
Design (DOE) and Analysis
Lean Six Sigma Training
Crucial Conversation Training Course
PATENTS
Preventing Norvaline and Norleucine Misincorporation in Recombinant
Proteins (WO/2007/103521).
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