Quality Control Development

Rizwan Manzer

** *** ***** **. *******, MA, 617-***-**** ******.******@*******.***

Professional Profile

MBA Post-Doctoral 15+ Years Life Sciences Experience

Scientifically accomplished bio-process professional with a strong

strategic focus and hands-on technical expertise. Author of 12 original

research papers in peer-reviewed journals, with a track record of

significant contribution in both academics and biopharmaceutical industry

settings. Excels at aggregating and integrating scientific and marketing

data to evaluate emerging and novel clinical therapies, and successfully

balances multiple competing priorities to meet scheduling and development

goals at lab and process scale.

. Cell Culture Biology & Processes

. GMP Procedures & Documentation

. Vendor Management & Negotiations

. Drafting IND & Regulatory Submissions

. Technology Transfer & Commercialization

. Early & Clinical Development

. Research Design & Optimization

. Bioreactor Lab Systems & Scale-Up

Professional Experience

Merrimack Pharmaceuticals, Cambridge, MA 2010 - 2014

Principal Bio-Process Scientist

Reported directly to the Vice President of Process Development, led drug

development scientists and engineers in the development of mammalian cell

lines and processes for clinical and potential commercialization. Drove

integration of findings into forward thinking research design, and

collaborated across engineering groups and clinical development teams on

systems-biology driven approach to drug development in oncology

indications.

. Evaluated technology and vendors for outsourced GMP manufacturing and

spearheaded negotiations with a Contract Manufacturing Organization

(CMO) that yielded $100K savings.

. Championed development of proprietary media and new-generation

parental cell lines to achieve significant improvements in process

efficiency.

. Advised scientific and operations executives on scientific viability

of potential targets during long-range strategy sessions and Blue Sky

planning meetings.

. Applied commercialization and industry knowledge to advance scientific

progress in line with business objectives, and presented actionable

insight across multiple therapeutic indications to support future

expansion.

. Designed and documented upstream processes for robust, scalable and

economical transition to a cGMP facility in preparation for late-stage

clinical and commercialization phases.

. Drafted and edited relevant portions of IND filings for regulatory

submission.

National Jewish Health, Denver, CO 2002 - 2010

Senior Researcher

Hired and developed junior staff and collaborated with other investigators

on research and peer-reviewed publication of findings with an emphasis on

acute lung injury caused by bacterial pathogens in rodent models.

. Developed in vivo rodent model of Severe Acute Respiratory Syndrome to

study innate immunity in viral pathogenesis, and devised protocols for

studying sterile inflammatory response of lung epithelial cells

exposed to ozone toxicity.

. Served as the technical lead and supported facility management in

establishing/maintaining compliance with all internal governance and

SOPs.

. Coordinated communication internally and with other active research

teams. Set priorities and managed expectations throughout planning,

execution, and publication lifecycles.

. Served on Technology Transfer workgroups to advance commercialization

efforts of innovative research, and played an instrumental role in

successful licensing agreements.

The Trizetto Group (Healthcare IT Company), Greenwood Village, CO 2008

Business Planning Consultant

Advised the principals of a premier healthcare IT outsourcing firm on

effective product R&D and positioning based on broad market and competitive

analysis. Utilized and leveraged Trizetto's extensive foot print and

knowledge base to develop enterprise solutions.

. Performed technical due diligence for potential transactions. Produced

and presented business cases to senior management.

. Initiated and designed secondary market research efforts while

concurrently providing essential quality control support to primary-

market study of broker and payer perception.

. Authored recommendations and reports for strategic organic and

acquisition-driven growth, and devised frameworks for questioning,

analysis, and management of study data.

University of Colorado Health Sciences Center, Denver, CO 2000 - 2002

Post-Doctoral Fellow

Developed independent research to study the protective role of ALDH3A1

protein in corneal epithelium in response to UV-induced toxicity in vitro

and in vivo mouse models.

. Expressed ALDH3A1 and identified metabolic function of the proteins,

and developed monoclonal antibodies against purified ALDH3A1 protein

for use in human corneal detection.

. Led project to successful identification of two novel genes and gene

sequences and subsequent submission to the NIH Gene Bank.

Institute of Genomics & Integrative Biology, New Delhi, India Summer 2000

Summer Research Fellow

Investigated and implemented research programs in collaboration with

leading Indian biotech, Bharat Biotech International, Ltd.

Education

University of Denver, Daniels School of Business (2006 - 2008)

Master of Business (MBA)

University of Colorado, School of Pharmacy (2000 - 2002)

Postdoctoral Fellow

Aligarh M. University, Faculty of Medicine, India (1995 - 1999)

Doctor of Medicine (MD) Biochemistry

Recent Conferences & Training

Biopharmaceutical Development & Production Week, San Diego, CA (2014)

Healthcare Conferences, Harvard Business School, Cambridge, MA (2012 -

2013)

Bio Process International Conference, Providence, RI (2012)

Bio Boot Camp: Building Life Sciences Business, Colorado Bioscience

Association, Denver, CO (2008)

"The Product Translation Pathway and Related FDA Regulation," BioMARC

Regional Training Center for Product Translation, Colorado State

University, Greeley, CO (2008)

Peer-Reviewed Publications

Funk C. F, Manzer R, Miura T.A, Groshong S.D, Ito Y, Travanty, E, Leete J,

Holmes K.V, Mason R.J. (2009) Rat respiratory coronavirus infection:

Replication in airway and alveolar epithelial cells and innate immune

response. Journal of General Virology.

Manzer R, Dinarello C.A, McConville, G and Mason R.J. (2008) Ozone exposure

of macrophages induces an alveolar epithelial chemokines response through

IL-1?. Am J Respir Cell Mol Biol. 38(3):318-23.

Mossel E.C, Wang J, Jeffers S, Edeen K.E, Wang S, Cosgrove G.P, Funk C.J,

Manzer R, Miura T.A, Pearson L.D, Holmes K.V and Mason R.J. (2008) SARS-

CoV replicates in primary human alveolar type II cell Cultures but not in

type I-like cells. Virology. 1; 372(1):127-35.

Wang J, Edeen K, Manzer R, Chang Y, Wang S, Chen X, Funk C.J, Cosgrove G.P,

Mason R.J. (2007) Differentiated Human Alveolar Epithelial Cells and

Reversibility of their Phenotype in Vitro. Am J Respir Cell Mol Biol.36

(6): pp. 661-8.

Wang J, Wang S, Manzer R, McConville G and Mason R.J. (2006) Ozone induces

Oxidative Stress in rat alveolar type II and type I-like cells. Free

Radic Biol Med., 40(11):pp.1914-28.

Manzer R, Wang J, Nishina K, McConville G and Mason R.J. (2006) Alveolar

epithelial cells secrete chemokines in response to IL-1? and

lipopolysaccharides but not to ozone. Am J Respir Cell Mol Biol.,

34(2):pp.158-66.

Jeyaseelan S, Manzer R, Young S.K, Yamamoto M, Akira S, Mason R.J and

Worthen G.S. (2005) TIRAP is critical for early lung immune responses

against E.coli LPS and Viable E.coli. Journal of Immunology,

175(11):pp.7484-95.

Jeyaseelan S, Manzer R, Young S.K, Yamamoto M, Akira S, Mason R.J and

Worthen G.S. (2005) Induction of CXCL5 during inflammation in the Rodent

Lung Involves activation of alveolar epithelium. Am J Respir Cell Mol.

Biol., 32 (6):pp.531-9

Ahmad S, Ahmad A, Manzer R, Mason R.J and White C.W. (2005) Lung epithelial

cells release ATP during ozone exposure: Signaling for cell survival.

Free Radic Biol. Med., 39(2):pp.213-26.

Pappa A, Estey T, Manzer R, Brown D and Vasiliou V. (2003) Human aldehyde

dehydrogenase3A1(ALDH3A1): biochemical characterization and

immunohistochemical localization in the cornea. Biochem J., 376(Pt 3):

pp.615-23.

Manzer R, Qamar L, Estey T, Pappa A, Petersen D.R and Vasiliou V. (2003)

Molecular Cloning and baculovirus expression of the rabbit corneal

aldehyde dehydrogenase (ALDH1A1) cDNA. DNA Cell Biol., 22(5): pp.329-38.

Manzer R, Pappa A, Estey T, Sladek N, Carpenter J. F and Vasiliou V. (2003)

Ultraviolet radiation decreases expression and induces aggregation of

cornea ALDH3A1. Chem Biol. Interact., 143-144: pp.45-53.

Technical Skills

Project Management and Communication: Preparation and presentation of

scientific presentations, mentorship of junior scientists, tech transfer.

Tissue Culture: Mammalian adherent and non-adherent cell culture for

primary and immortalized cell lines transient and stable transfection,

preparation of protein extracts, immunoprecipitation. Cell line

development: clone selection, cell banking, batch, fed-batch,

concentrated fed-batch process development. Process Scale-up (3L

Sartorius, GE Wave with Wave POD, Thermo Fisher SUB controlled by DeltaV

mounted Finesse controller)

Molecular Biology: Bacterial transformation, mammalian cell transfection,

Genomic DNA isolation, cloning and generation of plasmid constructs,

generation and isotopic labelling of DNA probes, single and multiplexed

qPCR, RNA Isolation, RT-PCR, electrophoretic mobility shift assay (EMSA),

Flow Cytometry (FACS)

Protein Chemistry: Protein expression, protein purification, protein

assay, affinity column chromatography, HPLC, Fortibio assay, SDS-PAGE,

western blotting, ELISA, enzyme assay.

Microscopy: Immunofluorescence, H& E

Bioinformatics: Data analysis, BLAST, primer design, Microsoft office,

Prism, JMP, ChemStation.

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