Simin Zaidi
Bioprocess Development and cGMP Manufacturing Leader
simin.zaidi@stamfordbio.com
Bioprocess engineering leader with extensive cross functional experience in the
Biologics industry. Expertise in bioprocess development, including management of cell
culture and purification development projects and departments for the production of
therapeutic recombinant proteins from mammalian cell culture. Determining strategy
for development of processes while ensuring Regulatory Compliance. Leader in
establishing Process Validation and Technology Transfer procedures. In depth
knowledge of operating under cGMP and implementing Quality Risk Management.
Expertise in process scale up and scale down modeling. Experience taking first
Commercial process for company through Approval and PAI inspections.
Troubleshooting and overseeing cGMP manufacturing investigations (root cause
analysis). Training of teams and personnel. Process change management. Multiple
publications in downstream techniques and processes.
PROFESSIONAL EXPERIENCE
Stamford Bioprocess Technologies – Santa Ana, CA USA
Director, Operations and Project Management February 2011 to Present
o Technical Consulting
o Purification and Cell Culture process development, optimization, characterization and validation
o Procurement of capital equipment for bioprocess facility
o Set up of technical and operational procedures
o Setting up processes in compliance with cGMP
o Developed Biosimilars Development package with detailed optimized timelines, costs and defined
milestones in order to maximize likelihood of success.
Avid Bioservices (fully owned subsidiary of Peregrine Pharmaceuticals) – Tustin, CA USA
Manager, BioProcess Development July 2004 to January 2011
o Leadership, Training and Mentoring
o Management of High level Technical Projects and Technical Personnel (senior
scientists, scientists, engineers, several associates (up to 8-10 direct reports))
o Built and Managed Upstream (Cell Culture) and Downstream (Purification)
BioProcess Development Department
o Scientific Leadership – Design of experiments and guidance of scientific personnel.
Ensuring scientific expertise of staff by staying up to date on latest purification and
cell culture manufacturing technologies.
o Scientific Development leader – Developed all aspects of platform process for the
production of antibodies which incorporated the most up to date technologies to
ensure process robustness and control (e.g. in-process testing).
o Oversaw the transfer of 20 production processes to cGMP (personally performed 6
hands on) for Clinical production
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Simin Zaidi
Bioprocess Development and Manufacturing Consultant
simin.zaidi@stamfordbio.com
o Formalized Technology Transfer methodology for company based on extensive tech
transfer experience (to cGMP manufacturing department/facility)
o One on one training and guiding of Scientists and Engineers in process development
procedures
o Identified need for and oversaw the introduction of DOE (design of experiments)
and FMEA (failure mode effects analysis) methods at Avid
o Process Development Laboratory planning, set up and management, purchase and
overseeing set up of new equipment such as 100L SUB (Single Use Bioreactor), AKTA
Pilot as well as Chromatography Columns (automated) and Purification skid for
manufacturing
o Incorporated process characterization as part of development process
o Process Validation Experience
o Key company leader in Process Validation strategy and execution
o Interaction with EM(E)A and FDA auditors on Process Validation package (no critical
observations)
o Trained client Scientists and Quality personnel on process characterization, risk
assessments and robustness studies.
o Writing process validation protocols and reports
o Designed and oversaw more than 10 virus validation projects to validate
removal/inactivation of virus from mammalian process (Clinical through Commercial
studies)
o Facility, Process and Raw Material risk assessments (Performed Risk assessments
(FMEA, fault tree analysis) on processes and manufacturing facility in support of
NDA Process Validation project)
o Raw material second sourcing
o Determining Critical and Key Process Parameters and Controls
o Individual process validation projects examples:
 Master Validation Protocols and reports
 Data analysis of data from multiple batches
 Determined sampling requirements from conformance batches in support of
process validation efforts
 validation of chromatography column cleaning,
 validation of fed batch cell culture process,
 validation of perfusion culture process
 Buffer and media hold studies
 Media release QC test studies and design
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Simin Zaidi
Bioprocess Development and Manufacturing Consultant
simin.zaidi@stamfordbio.com
o Example Clients and Projects
o Manage projects through interaction with all internal departments and external
clients to maintain commitments (timelines and deliverables)
o Primary technical leader to interact with clients as they take their projects from cell
line through banking, process development and optimization through cGMP scale
production.
o Example clients (only non-confidential listed)
 Roche (Phase I),
 Halozyme Therapeutics (Phase I through Commercial, and post approval
changes),
 Catalyst Biosciences/Wyeth (Phase I)
 Affitech (Phase I),
 DTRA (US Department of Defense’s Threat Reduction Agency),
 Mesoblast (Phase I and Pre-IND, IgG and IgM),
 Peregrine (Phase II),
 Salk Institute (Phase I)
 XTL Biopharmaceuticals (Phase I, 4 different antibodies)
 Wilex AG (Phase I through Commercial)
o Writing and review of technical protocols, reports, SOPs, and cGMP batch records, Regulatory
submissions
o Execution of technical investigations in support of cGMP manufacturing and analytics
o Troubleshooting processes – technical and operational (varied from successful microbial control
investigations, through successful process and analytical method troubleshooting)
o Experience with cell culture and purification of processes involving; cell lines: CHO, NS0 and other
hybridomas, proteins: huIgG, muIgG, chIgG, IgM, enzymes, Factor VII, product uses: therapeutic,
injectable, IgG to select stem cells for therapeutic use and protein for device.
o Scale Up and Transfer of over 20 processes to manufacturing ( 6 hands on)
Process Development Engineer, May 2002 to July 2004
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Purification Development, Scale Up and Technology Transfer to cGMP manufacturing
Virus Validations through Phase III
Cell culture development
Initiation and revision of controlled documents and SOPs for use in cGMP manufacturing
Project Management for first Clinical to Commercial project for Avid Bioservices (includes timelines,
status reports and weekly meetings involving all Avid departments), process technology transfer,
scale up to cGMP and process validation for first commercial process at Avid. Key participant in PAI
inspection for this project.
CRC Foodscience Australia (CSIRO) – North Ryde, NSW, Australia
Biotechnologist, June 1998 to December 1998
Plant Cell Culture process development and optimization (suspension culture, stirred tank bioreactors
for production of emulsifier). Technical reports and presentations.
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Simin Zaidi
Bioprocess Development and Manufacturing Consultant
simin.zaidi@stamfordbio.com
EDUCATIONAL BACKGROUND, COURSES AND CONFERENCES
Bachelor of BioProcess Engineering (with Honors) – 1996
University of New South Wales, Kensington, NSW, Australia
Engineering thesis project – identification and development of process to produce enzymes
capable of breaking down yeast cell walls from bioreactor culture of Trichoderma harzianum.
Final year Internship with Burns Philp R&D, North Ryde, Australia, optimizing yeast cell culture
production process.
IBC 3 Day Course – Process Validation, San Diego
IBC Conference, Process Validation, San Diego
BPI Conference –Upstream and Downstream Development 2006, San Francisco
ACS Conference, Anaheim
Company Training on Six Sigma concepts and tools, 2009
EXAMPLE PUBLICATIONS, PRESENTATIONS AND POSTERS
Biologics This Decade – Part 1- New Pharma Magazine, March 2012 issue
Developing an IND Enabling Purification Process for Commercialization, Sartorius Stedim’s Downstream
Technology Forum, Oct. 14, 2010, San Diego, CA
Hydroxyapatite as a Capture Method for Purification of Monoclonal Antibodies,
P. Gagnon, S. Zaidi, and S. Summers, IBC World Conference and Exposition, San Francisco, Nov. 6-9,
2006. Awarded Best Poster, Recovery and Purification
Dissociation and Fractionation of heavy and light chains from IgG monoclonal antibodies – P. Gagnon,
S. Zaidi et al, Journal of Chromatography A, 1218 (2011) 2402 -2404
Chromatographic behavior of IgM:DNA complexes – P. Gagnon, F.Hensel, S.Lee, S.Zaidi, Journal of
Chromatography A, 1218 (2011) 2405-2412
A ceramic hydroxyapatite based purification platform: simultaneous removal of leached protein A,
aggregates, DNA, and endotoxins, BioProcess International, 4(2) 50-60. P. Gagnon, P. Ng, C. Aberrin, J.
Zhen, J. He, H. Mekosh, L. Cummings, R. Richieri, S. Zaidi, 2006
Improved Monoclonal Antibody Production Through Re-Engineering Development Processes. –Poster,
Jeanette Doerr, Richard Archer, Connie Chang, Kristifer Garcia, Cristy Bautista, Claudia Guevara, Simin
Zaidi, Tom Tomzynski, Francis Aoalin, Scott Summers, Eva Fong, Steven King and Ronald T. Aimes
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Simin Zaidi
Bioprocess Development and Manufacturing Consultant
simin.zaidi@stamfordbio.com
A high speed monolithic assay for IgM quantitation in cell culture produiction and purification process
monitoring, Pete Gagnon, Richard Richieri, Simin Zaidi, Roy Sevilla, Alexander Brinkman, Third Wilbio
Conference on Purification of Biological Products, September 24-26, Waltham, MA USA
A comparison of microparticulate, membrane, and monolithic anion exchangers for polishing
applications in the purification of IgG monoclonal antibodies, Pete Gagnon, Richard Richieri, Simin
Zaidi, Franics Aolin, IBC International Conference and Exposition, October 1-4, Boston, MA, USA
Numerous presentations to clients and company employees (topics such as company capabilities,
technical projects, training seminars and operational processes (eg tech transfer).
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