Download PDF

Executive Summary

Experienced Ph.D. Biopharmaceutical leader with extensive experience in Gene of Interest Cloning & Expression Optimization, Microbial Fermentations, Protein Chemistry, Purification, Protein Folding, Characterization, Upstream & Downstream Process Development (Research to Commercial), Scale Up, Technology Transfer & cGMP Cell Bank & Drug Substance manufacturing & monitoring, improvements, solutions and Project Management.

Professional Achievements

  • Project Management:
    • Managed teams successfully for methods & process transfer and completed methods & process validation program (BioVectra, 2016-’17)
    • Manufactured GMP cell banks & released and Co-ordinated Analytical testing at third Party CMOs (BioVectra, 2000-Present)
  • Drug Discovery:
    • Isolated microbial strains for the discovery of new therapeutic agents (1993-‘94)
    • Expressed hepcidin like fish peptides in heterologous system, isolated, characterized and proved therapeutic property (NRC, 2004-‘07)
    • Synthetic molecules tested in-vitro & in-vivo for antimicrobial and anti-inflammatory activities (NATCO, 2002-‘03).
  • Cell Line Development:
    • Designed, constructed vectors and cloned hepcidin encoded genes in coli (NRC, 2004-‘07)
    • Cloned glycosyltransferase enzymes (JadS, UrdGT2) encoded genes in bacterial system (Dalhousie University, 2008)
    • Developed 10-fold high expression industrial strain for antibiotic production (Ph.D. 1997-2002)
  • Process Development:
    • Developed media using DOE, process with immobilized cells and continuous process for antimicrobial production (Ph.D. 1997-‘02)
    • Developed production media using DOE for Ansamitocin P3 production (KAIST, 2003-’04)
    • Developed processes for Biosimilar products (NATCO, 2002-’03)
    • Developed upstream & down-stream processes for microbial APIs and r-proteins in coli (BioVectra, 2008-Present).
  • Tech Transfer & Scale-up:
    • Tech transferred & scaled-up three cytotoxic microbial API processes to 1000L & 15000L (2008-Present).
    • Tech transferred & scaled-up five r-protein coli processes to 1000L & two native protein biologics to 10,000L scale (2008-Present).
  • Process Validation & Regulatory Support:
    • Process transferred and supported process validation for two biologic processes (BioVectra, 2016-’17)
    • Supported CMC and validation documentation for two biologic products (BioVectra, 2000-’17)
    • Designed Process Characterization Plan for CMO project (Phase III, BioVectra, 2016-’17)
  • cGMP Manufacturing & Engineering Support:
    • Manufactured cGMP cell banks, characterized and release tested (BioVectra, 2000-’17)
    • Manufactured & Lead the team for manufacturing clinical products (BioVectra, 2000-’18)
    • Written Batch records, QC procedures, Equipment training & cleaning docs, Investigated CAPAs (BioVectra, 2009-Present)
    • Sourced Process Equipment & Supported Qualification (BioVectra, 2010-Present)
    • Outstanding Achievement Award, Manufacturing Support (BioVectra, 2013)
  • Business Support & Capital Management:
    • Attend Conferences, networked and connected supply chain key personnel in the Industry with BD group for new business opportunities (BioVectra, 2000-Present)
    • Proposed business model, got approval and build Pilot 200L scale GMP suites (BioVectra, 2016-’18)

Work experience

2015Till Date
BioVectra Inc.

Director, Process Development & Technical Support - Biotech

  • A pilot scale facility business model was proposed, Capital budgeted for FY 2017 and received approval. As a team leader, worked with engineers to build pilot scale GMP bioprocessing clean rooms, procured equipment for upstream & harvest (200L fermentor, Disc-stack centrifuge & high-pressure homogenizer) & downstream (AKTA Pilot, K-Prime 40-I, TFF units, Single use buffer/product holding tankage) for 200L fermentation scale and supported qualification (Nov 2016 – On-going).
  • Led the Technical team in 2013, transferred the process to 15KL manufacturing scale on time, with improved product titers for the success of a project which contributed $25 million revenue in FY 2015.
  • Attended the conferences, built network with clients, and get connected to the internal business group to source the pipeline projects. 
  • Responsible for biotech projects technical evaluation, process facility fit assessment, predictive risk analysis, process and analytical transfer, scale-up to manufacturing scale. Nine projects including five recombinant & native therapeutic proteins and four small molecule potent compound projects were tech transferred to BioVectra manufacturing facility within nine years period.
  • Leading the upstream, downstream process & analytical teams for improved product quality, productivity, and efficient process/analytical transfer to the manufacturing & quality units. Designed scale-down models at 1L & 10L scales for efficient upstream & downstream process transfers to GMP production scale.
  • Interfaced with engineering, and manufacturing teams in designing of equipment or implementing new technologies for improved productivity, quality and manufacturing cycle time.
  • Responsible for troubleshooting production scale process issues and CAPAs by designing scale-down model experiments, executing, and generating scientific data to implement corrective and preventive actions.
  • Responsible for in-house or external manufacturing of GMP cell banks, characterization & release testing
  • Responsible for setting SMART goals for biotech process development & tech transfer scientists to meet the business goals which include project deliverables on time within budget, and process improvement through implementing new technologies.
  • Responsible for implementing safe workplace within the department implementing appropriate engineering controls, procedures and trainings to protect from bio-hazardous and potent compounds.
20162017
BioVectra Inc.

Project Manager & Director, PD&TS-Biotech

  • Led a $7 million value process validation program for two biotech products. Led the cross-functional teams, successfully transferred the process on time at lab & manufacturing scales, methods validated, coordinated to prepare the CMC & Quality documentation and completed the validation batches.
  • Projects handled:
    • Two natural enzymes expressed in fungal strains, harvested by disc-stack centrifuge & depth filtered and purified by differential membrane cut-off TFF and spray dried/crystallized. Process & equipment changes were effectively implemented during process validation based on data obtained from the scale-down models study. Supported schedule 2 filling to Environment Canada for approval to manufacture >1000L fermentation volumes.
20102014
BioVectra Inc.

Manager, Biotech Process Development

  • Led the biotech process development group (Ph.D. & MSc level scientists) and oversee GMP production activities for the manufacturing of drug substances for phase 1 & 2 trials in the absence of Director of Biotech operations.
  • Assisted business development groups in costing biotech projects and preparation of technical proposals for CMO/CRO/Government funded projects.
  • Responsible for internal regulatory documentation in place as part of R&D requirement and Prepared CMC sections as per client request.
  • Defined performance metrics, assessed the individual team member’s performance at defined intervals & recommended for improvements.
  • Acted as Biosafety Officer and coordinated with Canadian Government Regulatory Authority (PHAC) and applied for Containment level facility permits & cell line permits for importation.
  • Projects handled (2008-2014):
    • r-antibody fragment expressed in E. coli: Developed the process at lab scale and scaled up to 500L scale fermentation and following purification to produce 30 grams clinical batches. The down-stream process steps include; cell harvesting, cell rupture, IBs isolation, IBs solubilization, refolding, IEX chromatography (AEX & CEX), UF/DF and lyophilization.
    • Protein-Protein conjugation: r-antibody fragment conjugated to a natural plant protein using bifunctional linker, and purified (through IEX & TFF) to produce clinical batches.
    • r-protein, hormone-antagonist expressed in E.coli: Successfully tech transferred the process from client to in-house, process confirmed at lab scale, redesigned purification steps to reduce the endotoxin levels, scaled-up and manufactured clinical batches at 1000L scale successfully. The process steps include; cell harvest, Cell lysis, IBs Isolation, refolding, UF/DF, pH precipitation, UF/DF, IEX chromatography, and Lyophilization.
    • His-tagged soluble r-protein expressed in E. coli: Tech transferred to BioVectra and scaled-up to production scale. The Process steps include; cell harvesting, cell lysis, centrifugation, affinity chromatography purification, UF/DF and lyophilization. Successfully ran GMP clinical batches and supplied product for clinical trials.
    • Diagnostic r-protein expressed in E. coli: Identified issues in vector construction and host cell system selection. Redesigned the vector and host system, and selected stable clones for improved expression and supplied purified recombinant protein from 10L batch.
    • Band 4 Potent API from filamentous bacteria: Tech transferred from client to in-house, process confirmed at lab scale, scaled-up to 1KL scale GMP batches. Coordinated with engineering group for equipment change to fit the process. The challenges faced are contamination issues and time lines to deliver the product due to long production cycle and slow-growing micro-organism. Assessed process, equipment and operational aspects and identified root cause for contamination control.
    • Band 4 Potent API from filamentous bacteria: Tech transferred, scaled the process on EDC values to 1000L and 10KL scale and manufactured MCB, WCB GMP cell banks & characterized. Challenges during tech transfer were low titers with lack of micronutrients and finding appropriate scaling factor.
    • Band 4 potent API from marine bacteria: Tech transferred, scaled-up to 1000L scale GMP batches. Supported raw material evaluation and cell banks annual testing to support the GMP activities.
20082009
BioVectra Inc, Canada

Scientist, Pharma Products, R&D

  • Executed process development & process confirmation functions, tech transfer, scale-up, production support and change control activities. Ensured that all operating procedures (BPRs) are in compliance with relevant regulatory guidelines. Key performance index’s met for projects/operations as agreed with the Director of R&D.  Coordinated with the supply chain to procure raw materials, with QC and Analytical for the preparation of in-process and final QC documentation, and with QA for approval of all quality documentation.
  • On-site monitored & supported scale-up production upstream & downstream runs. Supported as required for Equipment IQ/OQ/PQ at production scale.
Feb 2008Apr 2008
Dalhousie University, Halifax, Canada

Postdoctoral Researcher

  • Cloned glycosyltransferase enzymes (JadS, UrdGT2) encoded genes in bacterial system with GST tag, expressed and purified to study their substrate specificity towards various sugar nucleotide diphosphates to synthesis Jadomycin analogs
Dec 2004Dec 2007
Institute for Marine Biosciences, NRC, Halifax, NS Canada

NSERC Visiting Fellow

  • Developed processes (from cloning to purified product) for recombinant therapeutic fish peptides containing 8 cysteines (fish hepcidins) using bacterial systems. Designed, constructed and evaluated various vectors to express peptides. Optimized expression, purification and refolding of peptides into active state with correct disulfide bond connectivity. Collaborated within NRC to characterize peptides by MALDI & ESI mass spectrometry and NMR studies. Evaluated these peptides for their therapeutic potential as antimicrobial agents using MIC assays (CLSI methods).
  • Collaborated with Dr. David Jakeman at Dalhousie University for testing new antimicrobials.    
Aug 2003Jul 2004
KAIST (Korea Advanced Institute of Science and Technology), Taejon, South Korea

Postdoctoral researcher

  • Applied statistical design of experiments (DOE); Placket-Burman design for screening media components and central composite design (CCD) and response surface methodology (RSM) for optimization of production medium of anasmitocins (AP-3) and improved the titers by ten fold.
  • Developed an optimized process for A. pretiosum wild strain and a deletion mutant strain at 5L scale to produce AP-3.
Jun 2002Jul 2003
Natco Pharma Ltd. Hyderabad, India

Scientist

  • Identified Technologies, collaborated with Universities, & National Research Institutes and transferred the technologies to the Industry. Identified market demand biosimilar products and proposed business proposals.
  • Designed & executed microbial, cell culture and downstream process development, and scale-up activities for biosimilars. Guided and assumed responsibility for all analytical, test and process development, project and organizational innovation for new product development. Ensured that all operating procedures are in compliance with relevant regulatory guidelines.
  • Projects executed: Developed lab scale process for Streptokinase from microbial, & Urokinase from mammalian cell culturing and scaled-up API intermediate from yeast to 500L scale.
Dec 1995Feb 1997
NET College of Pharmacy, India

Lecturer

  • Taught B.Pharm undergraduates on various courses; Industrial microbiology and pharmaceutical engineering principles for unit operations in the pharmaceutical manufacturing process.