PROFESSIONAL EXPERIENCE - Amazon S3 by xiaoyounan

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									                                             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
o   Purification Development, Scale Up and Technology Transfer to cGMP manufacturing
o   Virus Validations through Phase III
o   Cell culture development
o   Initiation and revision of controlled documents and SOPs for use in cGMP manufacturing
o   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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