CURRICULUM VITAE

Abhishek Gaurav Address: Mobile- +91 8141237229 +45 50155440 303, Raviteja enclave, V.NaganhalliEmail- abhigaurav1985@gmail.com Bangalore, India- 560032CAREER OBJECTIVE

Seeking a challenging position in the field of health science to utilize my knowledge & capabilities for the organization growth as well as personal growth and to have a better exposure for continuous learning.

EDUCATIONAL QUALIFICATION:

M. Sc. (Biotechnology) from SRM University, Chennai with 1st class. B.Sc. (Biotechnology) from BRABU Muzaffarpur with 1stClass.

COMPUTER KNOWLEDGE: MS Office, Knowledge of SAP (Production Module).

Project experience: Novo Nordisk A/S Copenhagen area, Denmark ( Basic design phase, ATEX environment)

Shantha Biotech Hyderabad, India (Extended BD)

Syngene International ltd Bangalore, India (Detail design phase)

HLL biotech Chennai, India (Detail design phase)

Novozymes Bangalore, India (Basic design)

TECHNICAL SKILLS:

Quality management system. o User requirement specification.o Risk assessment.o Design qualification report.o Process description.o Process module diagram.o Process flow diagram.o CIP strategy preparation.

o Risk management.o Change control and Deviations (Discrepancy Management).o Equipment Qualification.o Validation.o BPR Preparation, Filling & Review.o SOP Preparation and Revision.o Job Safety Analysis Preparation.

Packed and Handled BPG, Quick Scale Columns with purification system e.g. Akta explorer, AKTA Pilot, AKTA Process (10 mm, 1 inch) and AKTA Bioprocess system (3 mm, 10 mm) using UNICORN software.

Filtration processes involving various filtration modules like NFF and TFF (PALL C10, PALL C5, PALL CM 500, and Cogent M Scale).

Buffers Preparation and Filtrations (1000 L Scale). Integrity Testing of the Filters.

TRAINING EXPERIENCE:

Mice brain vaccine preparation of Japanese Encephalitis and Westnile virus at ICMR NE Region Assam.

Attended training on Filtration techniques from PALL. Training on Current GMP for Biologicals.

EXPERIENCE SUMMARY:

Current Employer: NNE PharmaplanDesignation: Process engineerExperience: January-2016-till today.

Previous Employer: INTAS PHARMACEUTICALSDesignation: Sr.Executive.Experience: Dec.2014- January-2016.

Dr Reddy’s (Biopharmaceuticals)Biologics Development CenterDesignation: Assistant ManagerExperience: March 2012 to Dec.2014

Panacea biotec ltd Lalru Punjab(Vaccine)

Designation: Scientific officer.Experience: Dec.2009 to March 2012.

CURRENT JOB PROFILE Validation of downstream process equipments. Preparation of Required risk assessment and User requirement specification of

equipments. Preparation of Process description. Preparation of Process module diagram. Preparation of Process flow diagram.

CIP/COP strategy preparation. Pressure drop calculation. Process capacity calculation. Utility consumption matrix preparation. Validation protocol preparation. Design qualification report preparation.

PREVIOUS JOB PROFILE:

Bio Bulk Manufacturing: (GCSF & Peg GCSF, Ranibizumab) Quality management system. Solubilization of Inclusion bodies and refolding of denatured Inclusion bodies ex-

pressed in E.coli. Buffer Preparation and Filtration for various steps. Purification of Recombinant therapeutic Proteins expressed in E.coli Sodium Cyanoborohydride preparation & Handling. Pegylation and Purification of therapeutic protein. CIP of in process vessels. Following cGMP Operations. Documentation.

Mammalian Cell Culture:(H1N1 Vaccine & R-MAb, Darbepoietine, T-MAb ) Clarification of Harvested Broth. Buffer preparation at 1000 L scale using MCS (Manufacturing Control System) Purification of Recombinant therapeutic Proteins & Vaccines expressed in Mam-malian Cell Culture. DS & ARM preparation.

Audit experience: U.S.FDA, Health Canada, European audit, DCGI, Iran FDA, Internal audits etc.

OTHER PERSONAL DETAILS:

Birth date : 5th December, 1985 Marital status : Married Languages known : Hindi & English Nationality :India

References: Mr.Jagdeesh Naidu

Sr.Scientist, Hospira ltd Chennai.Mob: 09962777397

Mr. Aslam KhanAssistant Manager, Santha biotech ltdMob: 09876466247

I hereby certify that the information contained in this application is true and correct.

Date – (Abhishek Gaurav)