Manager Manufacturing

PARIMAL SHETH PhD MBA

*** ***** **** ***; Columbia, MO 65202 (H) 573-***-****, (C ) 901-***-****. ************@*****.***

QUALIFICATIONS

Scientist with over 12 years’ experience in Cell culture, Fermentation, Protein Purification Processes, Cloning and Expression, RTPCR, MABs. Research in the area of Physiology, Mast cells, proteases, Tight Junctions and Oxidative stress, Signaling, Over 5 years’ experience in Operations and Manufacturing Management in ISO- GMP environment. Tech Transfer, Product Development, Inventory control, stocking and Distribution of Partnered Products, materials management Operations, Laboratory Operation. Process Improvement, Lean Six Sigma. Training, mentoring and, Quality System Compliance.

OBJECTIVE

I am detail oriented, hands on, a motivational mentor, possess strong interpersonal and data analysis skills. Provide rigorous scientific based program leadership. I take the extra steps required to overcome hurdles and achieve organizational goals while keeping abreast of new technologies. Seeking a position in Manufacturing or Laboratory Operations to manage and lead projects in the areas of IVD- Life-Science, biologics, Reference laboratories, Project Management, Process Development, or Research in the areas of drug discovery and signaling.

PROFESSIONAL SUMMARY

Currently working as Director – Laboratory and Quality System at IMMVAC Inc, Earlier as freelance Consultant in Life Science business, troubleshooting and setting up processes in Life-Science and IVD manufacturing, compliance and Tech training, at present working at Meridian Life Science Inc. on a consultation project. As Nights Operations Manager (IV) at IDEXX reference Labs. Overseeing lab operations with 6 direct and over 86 indirect reports. The job function involved, process improvement, General operations, recruiting, and meeting financial goals. To oversee operations of Parasitology, Hematology, chemistry, serology and cytology; I have Improved operational processes to increase gross margins, decreased operating expenses and meeting turnaround time. Implemented Lean six sigma and 5S in all areas. Previously at Meridian Life Science Inc.. with over 5 years as Director of manufacturing with 7 direct reports and a team of 26 manufacturing reports working on native and recombinant viral antigens, Antibody purification, Monoclonal Antibody production in a GMP environment. I have expertise in rec proteins and antigens, cell biology and process development Immunoassays, IVD intermediates and kits. I am an experienced research professional with more than 8 years of academic and 7+ years of industrial experience in the areas of cell and molecular biology, Immuno-chemistry, proteins chemistry, and managing the GMP environment, ISO and QSR systems. I am trained in Six Sigma and lean manufacturing.

SKILLS

Operations Management: Manufacturing & Production Control, Production Planning, Inventory control Stocking and Partner product Distribution & Client Service, Lean Manufacturing and 5S (Green Belt ).

Reference Laboratory Operations. Training and mentoring, Project Management

Quality system and Control : ISO – GMP compliance, Document Control and Batch record Review,

OSHA- ICH, IRB, CAPA, OOS and Risk analysis and Mitigation, Root cause analysis, Actionable Cause Analysis, Design Control (QbD), Validation methods.

Technical Process skills: Assay Development, ELISA, Upstream process development –Cell culture & Fermentation, Protein purification, Process Scale up, Cloning & expression, PCR, RTPCR, Monoclonal and Recombinant Antibodies, Assay Blockers and Formulation, Immunology. Primary Cell culture, Viral culture and purification.

MAJOR ACHIEVEMENTS

Lean manufacturing, Increased production from 6.8M to 24.8 m per year. Improved gross margin from 37% to 52 %.

Improved margin and Operating income through continuous improvement and tracking, Inventory reduction and control, scrap control and Process improvement.

Implemented training program for technicians, that brought robustness in operations, strengthen Quality system and decreased deviations, CAPA, and OOS.

Successfully completed Three tech transfers projects

Successfully transferred Partnered Products (over 4000 products from 500+ Partners) distribution business from MLS- ME to MLS- TN.

Successfully completed Consolidation Project for two manufacturing facilities merging in one without impacting customers.

Developed 12 new products in native antigen area transferred from R&D to manufacturing level

Started contract manufacturing of monoclonal antibodies through cell culture. Set up several antibody processes.

Developed and scaled up process for fermentation, expression and purification of recombinant antibody from E.coli host.(>100 gm/Lot)

HANDS-ON TECHNOLOGIES AND RELATED EXPERTISE

Operations and Quality: Laboratory operations and process control, recruiting, Optimization and improvement of processes, Planning and budgeting inventories, Implementation of lean and 5S concept to attain continuous improvement, Preparation of SOPs, Training and mentoring, Safety (OSHA) and ICH compliance and training. Cost saving through Process and Overtime control, inventory and scrap control. Through Scientific intervention making process more robust and cost effective. Quality, ISO GMP compliance, Cross functional Team talks with QA,QC and Regulatory department For testing and Documentation, Training and Audits, QbD, QRB and CAPA team member. Helped with Validation of equipment and Processes.

Upstream Processes: Cell Culture and maintain cell line and primary cells, cell banking and Cryo-preservation. Worked with primary and established epithelial cell lines, fibroblasts, reticulo-endothelial cells, and insect cell lines. gene expression manipulation and silencing by Anti sense and Si RNA, use of dominant negative, constitutively active gene constructs and TET On/OFF System. Immuno chemical staining, confocal microscopy and flow cytometry,

Recombinant proteins Cloning and Expression of protein and protein domains: PCR cloning and expression of tagged protein in E.coli, and insect cell lines, yeast vectors, maximizing expression, fermentation (2 – 1500 Lit), and scale up. Purification of Monoclonal antibodies from Ascites as well as cell culture route. Prepared cell bioreactors up to 35 lit capacities for suspension cells.

Assay Development Enzyme assay development, protein kinase and phosphatase assays. Protease assays, ELISA development for Mucins, Directed manufacturing of Veterinary kits, Manufacturing of Different immunoassay platform intermediates for IVD –Life-science business.

Protein Characterization & Site-directed mutagenesis protein purification from bacterial/insect cell mass and tissues, conventional and FPLC-based (AKTA FPLC) methods, protein characterization -Western blotting, SDS and native PAGE, MALDI, protein- protein interaction, immuno-precipitation and pull-down assays, enzyme assays and ELISA, and setting-up protein crystallization arrays.

Software: MS Office, DNA sequence management software, software with dedicated functions like confocal microscopy, flow cytometry, RTPCR, HPLC and FPLC utility software, statistical and graphic software.

Career Achievements

Published 14 full papers in reputed journals and 20+ abstracts presented in various symposia as oral or poster presentations.

PROFESSIONAL HISTORY

Director – Laboratory and Quality (July 2015 – Onwards)

Consultant : March 2014 – June 2015)

Nights Operations Manager (IV) (June 2013 – Mar -2014)

IDEXX Laboratories Inc. 6100 East Shelby Dr. Memphis 38141.

Overseeing operations of a reference Laboratory. The job functions include Improving operations process,, logistics, technology upgrade, Training, tech transfer, recruiting, meet deadlines, meet financial goals. Have 6 direct and over 86 indirect reports.

Director of Manufacturing (Jan 2008 – June 2013)

Meridian Life Science, Inc., 5171, Wilfong Rd, Memphis TN 38134

Directing manufacturing activities in the area of native and recombinant antigens, contract manufacturing and new product development. I have 7 direct reports with a staff of 16 technicians. Our group is responsible for $10+M antigen manufacturing activities, including Manufacturing activity for Native and Recombinant viral antigens and other IVD platform intermediates for leading diagnostics companies.

1.Manufacturing activity for Polyclonal and monoclonal antibody, IgG purification, Development of Blockers and conjugate formulations for IVDs

2.Quality system compliance, GMP- ISO compliance, audits,

3.Process development for contract manufacturing

4.Tech Transfer From R&D to Manufacturing,

5.Tech support and trouble shooting for customers through client services, sales and marketing department. Partnered Product Distribution and stocking decisions

6.New product development and customization of antigens, Antibody antigen pairing,

7.Continuous process improvement with Six Sigma.

Implemented Six Sigma project in my current position and have improved margins on all products by 10 -15 % over our earlier margins. This was achieved by going lean on workforce and increasing efficiency of manufacturing processes by scientific intervention and process improvement. Training and cross training of workforce and inventory management. I have been instrumental in tech transfer and implementation of the recombinant protein project, Consolidation of manufacturing and distribution business.

Developed and customized six new products that are currently being put through design control.

Rectified the toxo plasma antigen process and it is now a highly robust and controlled process.

Improved margins on all native and recombinant antigens through lean manufacturing and process de-bottlenecking.

Successfully carried out complete tech transfer for recombinant protein from Vybion Inc. to Meridian Life Science and similarly transferred veterinary product lines from Meridian Life Science to a company in California.

Other positions held at Meridian Life Science Inc.

Manufacturing Manager (Jan 2010 – Jan 2011),

Manager, Cell Culture and Vet. Kit Production (Oct 2008 - Jan 2010),

Investigations Manager (Jan 2008 - Oct 2008)

RESEARCH EXPERIENCE

Research Associate (Aug 2007 – Dec 2007)

Department of Physiology University of Tennessee Health Science Center, Memphis

Duties:

Managed lab resources, ordering, helped PI with manuscript, reports and presentations, trained graduate students, performed troubleshooting and equipment maintenance.

Developed new project in the area of barrier function and permeability in retinal vascular endothelial cells.

Cloning in AAV and Expression- Transient and stable, Banking Viral libraries.

Achievements:

Standardized the culturing of micro vascular endothelial cells on porous supports.

Standardized the barrier function models for these cells and collected preliminary data establishing changes in junction protein following different bioactive molecule treatments and hypoxia.

Research Lab Specialist (April 2006 – Aug 2007)

St. Jude Children’s Research Hospital, Department of Oncology Memphis TN 38104

Project:

Studied the structural and functional aspect of cytoskeletal proteins with reference to focal adhesion complexes. This involved cloning, expressing, purifying, and crystallizing human cytoskeletal protein complexes for crystal structure determination and functional assays.

Other Duties:

Managed lab resources, ordering, helped PI with budgeting, training junior members, troubleshooting, and equipment maintenance.

Instructor- Research (April 2004 - April 2006)

Post-doctoral Fellow (Aug 2002 - April 2004)

Department of Physiology University of Tennessee Health Science Center, Memphis TN 38163

Projects:

Signaling pathways regulating tight junctions and barrier function in epithelial cells (Caco2, MDCK).

Effect of Oxidative stress and alcohol feeding on Barrier function of intestinal epithelial cells and study of protective mechanism, probiotics and growth factors.

Studying the regulation of tight junctions in intestinal epithelial cells (Caco 2, IEC6) and bile duct epithelial cells (NRC-1) and role of protein phosphatase and protein kinases in regulation of barrier functions.

Techniques Employed:

Cell culture, Cell transfections and Gene silencing (Si RNA, anti-sense oligo transfections)

PCR cloning and expression of GST-fusion proteins

in vitro protein-protein interaction (pull down assays), immunoprecipitation, immunoblotting

confocal microscopy Enzyme assay development,

MALDI TOF and limited proteomic analysis

Other Duties:

Managed lab resources, ordering, helped PI with manuscript, reports and presentations, training graduate students, troubleshooting and equipment maintenance.

Research Fellow (May 2000 - July 2002)

University of Southampton Southampton General Hospital, Southampton, Hampshire, UK

Project

Postdoctoral research of mast cell tryptase and other proteases and their role in asthma and inflammation

a) Worked on role of mast cell Tryptase and regulation of tryptase activation ex vivo

b) Studied role of mast cell enzymes in regulation of mucin secretion in bronchial epithelial cells (A549, H292, 16HBE). Role of PARs in mucin secretion and up-regulation of MUC genes. Development of ELISA assay for Mucin (muc5AC)

Senior Lecturer (Jan 1990 - May 2000)

St. Xavier’s College Department of Biochemistry Ahmedabad, Gujarat, IND

Teaching Biochemistry and Biotechnology at an undergraduate level.

Supervised research in the area of plant tissue culture and trained students on mocked or simulated industrial units in plant biotechnology.

Research Officer (Aug 1987 - Jan 1990)

Cadila Laboratories Ltd Cell and Molecular Biology (R&D Div.) Ahmedabad, Gujarat, IND

Research officer in Cell and Molecular Biology Division in the Research and Development section. Supervised a team of five members working on:

Cloning and expression of insulin and bovine Growth Hormone (bGH),

Immunodiagnostic products (mainly Elisa-based)

Protoplast fusion and strain improvement of antibiotic producing streptomyces strains

Optimization and scale up of Rifamycin fermentation conditions

EDUCATION

PhD (1996) Biochemistry Gujarat University- School of Sciences Ahmedabad, Gujarat IND

Major: Biochemistry (enzymology)

Thesis Title : Purification and characterization of Tryptases from different vertebrate skin.

MBA (1997) B.K. School of Management Ahmedabad, Gujarat IND

Major: Marketing, Operations and Production management.

M.Phil (1986) University of Poona Pune, Maharashtra IND

Major: Zoology (Genetic Engineering)

M.Sc (1983) Faculty of Science, M.S. University of Baroda Baroda Gujarat IND

Major: Biochemistry

CERTIFICATION

1.Lean Six Sigma Green Belt Certificate (Smarter Solutions Inc.)

2.ISO – Root Cause Analysis and CAPA

3.Creative Problem Solving and Actionable Cause Analysis

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