Paresh Pujara

HELLO
I'M PARESH PUJARA

Biopharmaceutical Professional

PROFILE

JOURNEY SO FAR

Paresh Pujara

GET TO KNOW ME...

My name is Paresh Pujara and I am a well-rounded Biopharmaceutical professional.

In my academic background, I have specialized in Microbiology, Biotechnology and Biochemistry. In the earlier phase of my academic life, I developed a strong interest into protein chemistry and protein based drugs to cure/prevent life threatening diseases.

Due to my interest in protein based drugs, I started my career as a Research Associate in the R&D facility of a leading Biopharmaceutical company in India where I worked on recombinant human (rHu) biotherapeutic proteins and its derivatives. It was an awesome opportunity for me to explore protein purification technology development, analytical testing method development, formulation development, technology transfer and scale-up. In my subsequent assignment as a Technology Lead, I managed multiple operations on shop floor and accomplished validation and IPR related activities. Currently, I am working as a Bulk Manufacturing Manager in the world leading vaccine manufacturing company in Canada. In my current role, I am a part of the manufacturing team to build a brand new advanced vaccine manufacturing facility for capacity expansion. It is a unique opportunity for me to experience the genesis of cGMP compliant manufacturing facility and all critical milestones associated with it.

With more than nine years of experience, I clearly feel that Biopharmaceutical manufacturing and development is truly a passion of mine. I love what I do and It is my way of contributing towards better healthcare for tomorrow’s world.

In personal life, I am always up for a good book, camera and hiking trails. I am a great admirer of Mahatma Gandhi who very famously said “Be the change that you wish to see in the world”

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RESUME

EDUCATION

Master of Science in Biochemistry (2011-2013)

University of Saskatchewan, Saskatoon, SK, Canada

Master of Science in Biotechnology (2006-2008)

Ganpat University, Kherva, India

Bachelor of Science in Microbiology (2003-2006)

Gujarat Vidyapith, Ahmedabad, India

EXPERIENCE

Bulk Manufacturing Manager / December 2018 - Present
Sanofi Pasteur Canada

  • Responsible for vaccine bulk manufacturing operation (Upstream and Downstream) in $150M capacity expansion project
  • Enforce strict adherence with company Health, Safety and Environment (HSE) policy and Good Manufacturing Practice (GMP) requirements in manufacturing area
  • Review and approve standard operating procedures, batch records, protocols, reports and technical documents
  • Participate and track department deviations, CCR and CAPAs
  • Respond to facility and equipment maintenance/break-down request and work with technical services to solve the issue
  • Perform risk assessment and root cause analysis
  • Lead biosafety HAZOP assessment and closely manage work place related injuries
  • Develop training strategy and metrics to expedite on the job training of new hire employees
  • Schedule and track daily activities and evaluate team performance
  • Serve as Subject Matter Expert (SME) during regulatory inspections and address queries
  • Understand internal supply-chain system and market demand to meet manufacturing targets
  • Demonstrate leadership to implement 24/7 manufacturing schedule
  • Interview, recruit and reward required talent for the project
  • Project and people management – eam building, conflict resolution and negotiation

Visting Faculty / September 2018 - Present
Academy Of Applied Pharmaceutical Sciences (AAPS) Inc., Canada

  • Teach Course - Micobiology of Cannabis
  • Train aspiring industry professional on Good Laboratory Practices (GLP)
  • Demonstrate hands on experiments in laboratory
  • Explain clean room requirements for biological product manufacturing

Technologist / November 2014 - December 2018
Sanofi Pasteur Canada

Worked as a Technologist in manufacturing team of capacity expansion project of 5aCp vaccine for pertussis.

  • Execute Midstream and downstream purification processes for vaccine manufacturing in GMP environment – Centrifugation, Microfiltration, Ultrafiltration, Chromatography and Salt precipitation
  • Actively participate in validation activities - Equipment, thermal and cleaning validation, Process validation and Environmental monitoring (EM) validation of Grade - D, C and C-1 manufacturing facility
  • Update technical documentations - P&ID, Functional Requirement Specification (FRS) and Detail Design Specification (DDS)
  • Execute process validation protocols - Cycle development and Engineering run batches
  • Prepare comprehensive Training curriculum / Lesson plans for downstream processing department and provide technical training o the production floor.
  • Perform necessary SAP transactions for work order initiation, stock status updates and co-ordinate maintenance activity
  • Routine environmental monitoring and Utility sampling (WFI, PW, Clean steam and compressed air)
  • Design and implement engineering solutions to avoid potential Hazards in manufacturing facility

Project Manager / Technology Lead Consultant /
January 2014 - August 2014
Pacemaker Pharmachem, India

Worked as a Technology Lead in Bulk Manufacturing Support (BMS) Division of Pacemaker Pharmaceutical Ltd., India.

  • Lead project management stream
  • Review documents related to technology transfer and conduct process cost analysis
  • Prepare URS and provide IOQ support for multiple bench-top Instruments
  • Identify the critical process parameters (CPP) and perform worst case studies to create risk assessment matrix
  • Assist Quality Assurance (QA) team to file and investigate deviation related to analytical testing and manufacturing processes
  • Perform Data analysis using statistical tools
  • Support product portfolio management and intellectual property (IPR) teams with technical inputs
  • Coordinate intra-departmental activities to track development of in-house product development projects
  • Implement 5S principle to improve industrial operation efficiency

Research Associate / July 2008 - December 2010
Intas Biopharmaceuticals, India

Worked on development of Bio-therapeutic proteins like Interferon alfa-2b, Erythropoietin and Rituximab in GMP environment as Research Associate in R&D (Downstream Processing) division.

  • Execute purification of recombinant human (rHu) therapeutic proteins expressed in mammalian cell culture and bacterial host using chromatography techniques - Affinity, Ion exchange, Hydrophobic, Reverse phase and Gel filtration. Non-chromatography techniques - Refolding, Protein/Impurities precipitation, Dialysis, Tangential flow filtrations (TFF), Virus inactivation by pH. PEGylation of rHu-therapeutic proteins
  • Support purification technology transfer from R&D to manufacturing facility
  • Assist in submission of the pre-clinical and clinical trial data package of a novel bio-molecule to a regulatory agency
  • Perform molecular weight determination (SDS-PAGE & SEC), isoelectric point determination (IEF), quantification of protein (Bradford method, BCA and spectrophotometry), Purity testing (RP/IEC/SEC-HPLC), isoform profiling (IEC-HPLC, western blotting) and Immunoassay (ELISA) and impurity characterization
  • Perform stability studies of rHu-therapeutic proteins and assisted in non-infringing formulation (NIF) development
  • Analytical method development, qualification and transfer to QC for lot release, stability analysis and in-process analysis
  • Conduct Introductory Good Laboratory Practices (GLP) Training for new hire employees

Executive (Co-Op) / June 2007 - July 2008
Pacemaker Pharmachem, India

Worked as executive in fast paced pharmaceutical industry with following deliverables:

  • Sample management and documentation support to process improvement team
  • Assist documentation team in SOP, protocols, validation report writing
  • Buffer and microbial media preparation
  • Raw material testing and inventory tracking
  • Archive COAs and MSDS for raw material

KEY KNOWLEDGE AREAS

Biopharmaceutical Manufacturing

Statistical Data Analysis

Quality by Design (QbD)

Downstream Processing

cGMP

21 CFR 11 211

Biotechnology

Technology Transfer

Process Validation

Cleaning Validation

Thermal Validation

Equipment Validation

Product Development

Protein Chemistry

Analytical Testing

Process Improvement

Technical Writing

Training

HSE

Project Management

ACHIEVEMENTS

Certificate Courses

  • Successfully completed certificate course on Biotechnology and Intellectual Property (DL-204) from World Intellectual Property Organization (WIPO) Academy (2013)
  • Successfully completed Fast-track MBA (FMBA) in Biotechnology Management from National Institute of Management (NIM), India (2009)

Professional Credential/Certifications - Continuing education

  • Currently pursuing Pharmaceutical GMP Professional Certification (CPGP) from American Society for Quality (ASQ) and project management professional (PMP) from Project management Institute (PMI).

Industry Awards

  • GenBio-Next Award (2010) by Intas Biopharmaceutical Ltd. India for conducting independent research study to evaluate commercial potential of a novel Bio-theraputic molecule
  • Recognition award (2015) by Sanofi Pasteur Canada for troubleshooting problems and successfully commissioning Alfa-Laval B-TUX centrifuge

Academic Awards

  • Original research poster presentation award at 3rd Plant Metabolism Conference 2012, Banff, AB
  • Scholastic performance award (recognition of high academic achievement in graduate program- MSc.)2008 and 2009, Ganpat University, India
  • Young Innovator (Science) award 2007 for presenting research on development of novel pH indicator from natural sources, Kadi University, Gujarat, India
  • Shree Rajendrabhai Desai Memorial award 2006 (Gold medal - recognition of highest academic achievement in undergraduate program- BSc.), Gujarat Vidyapith, Ahmedabad, India.

Research Papers

  • Barber, C.J., Pujara, P.T., Reed, D.W., Chiwocha, S., Zhang, H., and Covello, P.S. (2013). The two step biosynthesis of cyclic peptides from linear precursors in a member of the plant family Caryophyllaceae involves cyclization by a serine protease-like enzyme. J. Biol. Chem. 288, 12500-12510.
  • Shah, M.C., Shilpkar, P.G., Pujara, P.T., and Shah, A.J. (2008). Extract of Clitoria ternatea L. flowers: natural universal pH indicator. Bioscience Reporter. 6 (2), 375-378.
  • Shah, M.C., Shilpkar, P.G., Shah, A.J., Pujara, P.T., and Zaloirya, P.V. (2006). Assessment of drinking water quality of various railway stations on Ahmedabad to Khedbrahma train route in Gujarat, India. Pollution Research. 25 (3), 549-552.

Book Chapter

  • de Costa F., Barber C.J.S., Pujara P.T., Reed D.W., Covello P.S. (2016). Purification of a Recombinant Polyhistidine-Tagged Glucosyltransferase Using Immobilized Metal-Affinity Chromatography (IMAC). In: Fett-Neto A. (eds) Biotechnology of Plant Secondary Metabolism. Methods in Molecular Biology, vol 1405. Humana Press, New York, NY

Characterization of peptide cyclase 1 (PCY1), a serine protease-like enzyme involved in cyclic peptide biosynthesis in plants.

In general, proteins/peptides are linear but surprisingly some proteins/peptides have circular structure. Cyclic peptides are small group of peptides with a circular backbone. A very little was known about the biosynthesis of these peptides in nature. The research project was aimed to decode the molecular mechanism in biosynthetic pathway and characterization of the key enzyme involve in cyclization of procedure.
Skills: Homology modeling, protein purification, chromatography, mass spectrometry (LC-MS), Surface plasmon resonance (SPR)

Pegylation of recombinant human (rhu) therapeutic protein molecules

PEGylation is the process of attaching the strands of the polymer PEG to molecules, most typically peptides, proteins, and antibody fragments, that can improve the safety and efficiency of many therapeutics. Multiple drug candidates were developed for commercial market with increased serum half-life and improved pharmacokinetics.
Skills: Protein chemistry, PEGylation, HPLC, Chromatography (FPLC), Dialysis, Ultrafiltration and Nanofiltration

Functional domain recognition of olfactory marker protein (OMP) by block analysis

Olfactory marker protein (OMP) is a cytoplasmic protein found in mature olfactory receptor neurons and also involved in signal transduction. Research project was conducted to understand the functional domains of the OMP and its role by various protein-protein interaction methods.
Skills: Protein-protein interaction, protein sequence analysis, 3D structure assessment, Bioinformatics

Novel universal pH indicator development from natural source.

Ever wondered why pH indicator display different color at different pH? This intriguing question started a research project to understand the chemistry of pH indicator and development of universal pH indicator from natural source. After careful screening procedure, five flower extracts were chosen for the project and the results were summarized and published. This work presented at multiple scientific conference and won awards.
Skills: Acid-base titration and Spectrometry

Physiochemical and Biological analysis of potable water collected from railway stations.

It all started with a simple question asked by a friend 'is it safe to drink water on railway station?' An widespread sampling was done and a team of four young undergraduate students conducted thorough chemical and biological analysis of all samples. The data was complied and tested by statistical methods to draw conclusion. This work got lot of attention in local community and helped to create awareness in public health and welfare.
Skills: Microbiology MPN method, Analytical chemistry, Statistical analysis

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