HARMESH K. SHARMA, PH.D.

BIOMANUFACTURING EXPERT
A scientist with more than 20 years experience driving revenue and profitability within Life Sciences by resolving complex issues with protein stability and aggregation, and potential problems related to customer compliance and specifications in ISO13485 manufacturing environments. Skilled in downstream process development and their scale-up, evaluating transferred processes from clients, transferring processes from process development to manufacturing and developing formulations for protein products. Can lead teams of scientists and cross-functional project teams by building consensus and fostering a results-oriented environment while creating accountability.

WESTBORO, MA 01581 HARMESHSHARM@AOL.COM(508) 740-3338

Protein Design for Stability Downstream Process Development cGMP, ISO9001 & 13485 Manufacturing Protein Processing to 500L QC of Vaccines and Injectables Validation of Assays and Processes Project Management

SCIENTIFIC EXPERTISE
PROTEIN DESIGN Antigenicity, hydrophobic tendencies, protease susceptibility and chromatographic profiles of HBsAg, RF and coat protein Use of Expasy, Python and MPex tools Antibody production against peptide epitopes and whole proteins Monoclonal by phage display, hybridoma and polyclonal in rabbits and turkeys DOWNSTREAM PROCESSING Removal of cell debris with depth filtration Concentration by salt and PEG precipitation, salting out of IgM, ultracentrifugation and diafiltration. Semi Purification by hydroxyapatite (CHT), IEC on ABx and Monolith resins, gel filtration, Protein A and G chromatography with AKTA-100 and negative adsorption to silica and/or charcoal resins. Protein Processing to 500L scale Batchwise immunoaffinity purification to 200L scale Bioformulation of protein solutions to 200L and process transfer to CRO Made a business case to buy AKTAprocess for large purification PROTEIN/ANTIBODY CHARACTERIZATION VALIDATION OF PROCESSES Functionality by immunoassays & affinity binding, kinetic rates and interferences by Biacore Purity by PAGE, SDS-PAGE, IEF, peptide mapping, Western Blotting, Sephacryl-400 and AUC Detection of small cell growth inhibitors, proteases, nucleases, endotoxins and beta-glucan RO/DI Water System for USP27&30 pharmaceutical water Gaylord shipping containers by thermal mapping using Kaye Validator 2000 COP of mixing tanks, centrifuges, autoclaves, etc. Assisted in the validation of a diafiltration skid equipped with two UFP-10-E-85 columns
CGMP AND REGULATORY

Scaled up and transferred process from Class1 to Class 8 clean-rooms in ISO9001 and 13485 facilities Evaluation of critical raw materials, vendors and testing sites

2 | HARMESH K. SHARMA, PH.D.

HARMESHSHARM@AOL.COM(508) 740-3338

PROFESSIONAL EXPERIENCE
SERACARE LIFE SCIENCES/BBI INC. MILFORD, MA
GLOBAL PROVIDER OF PRODUCTS THAT FACILITATE THE DISCOVERY, DEVELOPMENT AND PRODUCTION OF HUMAN DIAGNOSTICS AND THERAPEUTICS.

2001 TO 2013

PROCESS ENGINEER (2008 TO 2013) Designed, specified and documented processes within this ISO13485 Certified biomanufacturing environment. Presented a comprehensive business case for investing in new technology and equipment, including evaluating vendors and developing budgets. Provided troubleshooting and support to process technicians involved in the everyday manufacturing of biomedical and biopharmaceutical products. Collaborated with manufacturing, R&D, customers and senior management to ensure projects were on track to meet client, company and regulatory requirements. Made a case for HBsAg aggregation as a reason for decrease of its stability in Accurun products (a 1.5 million business). Used bioinformatics tools to illustrate membranous and proteolytic tendencies of the molecule. Investigated the Cal5 stability and recommended the use high quality RF Stock (IgM) and low IgG diluent. Invited to speak at the Society of Chemical Engineering and Biotechnology at Frankfurt, Germany, 2011 on the use of Bia Separations Monolithic Chromatography for IgM purification. Achieved customer requirements in the growth of hematopoietic stem cell-lines by developing a process to manufacture 3 x 1kG lots of human serum albumin in lyophilized form. Achieved strategic market positioning and differentiation by developing and launching Seracon Vitamin D Depleted Diluent (500L process size) with D2/D3 levels of <1ng/mL, the lowest concentration in the market. Troubleshooting silica precipitation in Seracon II (500L batch). Implemented three SOPs. Qualified chemicals from alternative vendors to save manufacturing expense budget Validated RO/DI water system to meet USP27&30 requirements for pharmaceutical water (800gal/day). Validated the COP in the cGMP manufacturing operations by the microBCA method. Exceeded client requirement of products staying frozen for two days in the Gaylord Containers by using thermal mapping of the products in the partial and full containers. Thesis Advisor to a colleague for acquiring M.S. degree in Biochemistry from Hood College, MD. SENIOR PRODUCT MANAGER, PRODUCT ENGINEERING (2001 TO 2008) Identified opportunities to expand product portfolio, in line with customer needs and drive strategic growth: Developed large-scale purification of HBsAg from diseased state human plasma. Validated virus inactivation process in human plasma by heat, Gambro and CUNO technologies. STATE BIOLOGIC LABORATORIES JAMAICA PLAIN, MA
FDA-LICENSED MANUFACTURER OF VACCINES AND BIOLOGICS

2000 TO 2001

QUALITY CONTROL MANAGER FOR ASSAY VALIDATION Directed four scientists for retrospective validation of assays for specifications of human derived blood products as well as vaccines against Respiratory Syncytial Virus, Varicella Zoster, Diphtheria and Tetanus. Two assays were used to FDA Form-483 compliance on Solvent Detergent Inactivation of Viruses. COP of biopharma equipment such as mixing vessels, centrifuges, autoclaves, etc. GENZYME CORPORATION CAMBRIDGE, MA
A GLOBAL PIONEER IN THE DEVELOPMENT AND DELIVERY OF TRANSFORMATIVE THERAPIES FOR PATIENTS AFFECTED BY RARE AND DEBILITATING DISEASES.

1992 TO 1998

PRINCIPAL SCIENTIST (1994 TO 1998) AND SENIOR SCIENTIST (1992 TO 1994) Identified epitopes for HCCR2, HCCR3, HCCR5 and HCCR8 & produced polyclonal for the whole proteins.

EDUCATION
PH.D., BIOCHEMISTRY Indian Institute of Science Bangalore, India

INTERESTS:

RUNNER, CURRENTLY Competed in his eighth consecutive Boston Marathon