Dear Sir / Madam,

I would like to introduce myself as Balachander Dappuri, a Biotechnology professional having 11 years of industrial experience. Currently I am working with Syngene International Limited as an Assistant Manager and implementing LIMS (Labware) into Quality control, Biologics. Leading the product support team, executing the batch release (in-process to finished product), stability & reserve sample management. Supervising the QC team in systematic functioning. Herein, I would like to explore job opportunities for myself in your organization and towards this; I am enclosing my curriculum vitae as an attached document.

Kindly spare some time to have a look at my CV and then let me know if my profile fits any of your organizational requirement.

I shall look forward to hear from you at your earliest.

Kind regards,

Balachander Dappuri

CURRICULUM VITAE

Balachander Dappuri,

Flat No-204, 13th Cross

Ananth Nagar Phase-2

Electronic city Mail : admotz@r.postjobfree.com

Bangalore -560100 Mobile : 996-***-****, 798*******

Career Objective

Looking for a challenging professional career in the area of Bio-pharma (Biosimilars / Vaccines), where I can explore my skills and technical experience

Professional Experience:

Currently working at Syngene International Limited as an Assistant Manager in Quality Control Biologics department from May 2019.

Previously worked at Indian Immunological Limited (IIL) as an Executive in Human Biologicals Institute, since January 2017 in the Quality Control Department. Responsible for testing of Biochemical, Immunochemical and Chromatography methods of TT, DT, Pertussis, Hepatitis-B and Haemophilus influenza type b, Pentavalent, Rabies, Hepatitis-A and Typhoid from January 2017 - May 2019.

Previously worked at United States Pharmacopoeia (USP) as “Scientist II” in Analytical R&D of the Biology & Biotechnology Department. Responsible for method development, validation of analytical methods, development of Vaccine Monographs and Reference Standards for biologics from February 2013 – December 2016.

Previously worked at Biological E Ltd, as an “Executive” in the Quality Control Department and worked on testing of Japanese encephalitis vaccine from February 2010- February 2013.

Current Employer:

Syngene International Limited:

Syngene is an internationally reputed contract research and manufacturing organization, which supports R&D programs from lead generation to clinical supplies. Syngene has state-of-the-art research facilities certified with ISO 9001:2008, ISO 14001:2004, and OHSAS 18001:2007. Over the last 25 years, we have successfully offered these services to more than 331 clients including start-up companies, large pharma/ biotech, agrochemical, chemical, nutrition and animal health companies in the USA, Europe and the Asia Pacific including Japan and Australia. Syngene has a strong corporate governance framework with a focus on client satisfaction, quality, safety, ethics and integrity. Our ability to deliver significant value to our customers by leveraging our scientific skills, global mindset and India’s cost competitiveness differentiates us as one of the most preferred partners.

Job responsibilities in Syngene International Limited:

•Co-coordinating and supporting to the team for the preparation and review of QMS documents such as SOPs, IOPs, EOPs, and batch release documents, Protocols etc.

•Responsible for SQDECC (safety, quality, delivery, engagement, cost and compliance) and daily performance is reviewed through visual dashboards installed at shop-floor level.

•Thorough understanding of data integrity requirements.

•Responsible to conduct regular Gemba walks - to provide a framework for detailed interactions at the shop-floor level in order to resolve problems and drive operational improvements.

•Responsible to check and review all the compliance documents on time for equipment and instruments like calibration records / reports and log books.

•Responsible to prepare and review the Method transfer, Method validation and verification protocols.

•Responsible to manage a team by supporting for routine testing operations and release of COAs, observation data sheets along with the analytical data, analysis report on time to QA and customers / clients for batch release.

•Responsible to troubleshoot the technical problems (related to HPLC & CE) and to provide technical guidance to junior staff.

•Responsible to manage all internal and external client audits.

•Responsible for LMS training to the Junior staff.

•Responsible for reviewing of new joiners training records and analyst qualification records.

•Responsible to interface with customers / clients to understand and establish requirements to meet and deliver their needs.

•Ability to independently plan, organize, coordinate, manage and execute assigned tasks.

•To provide line clearance for manufacturing operations and to ensure online documentation. Responsible for working closely with cross functional senior management and establishing and maintaining Quality system to assure compliance and to meet company business needs.sks.

•Leading Bioassay lab.

LIMS Specialist (Labware 7):

•Responsible for Implementation of LIMS in QC.

•Experience in Labware Modules like LIMS Stability, LIMS Instrument module, LIMS Inventory module, Lot and Sample Management.

•Configuring and integrating instruments with Labware LIMS systems for calibration and preventive maintenance activities.

•Implementing tables like Item code, Product, Analysis, Components, Sample plan, Instruments and Inventory.

•End to End Product configuration knowledge.

•Analysis configuration with components (calculations & thorough knowledge of variations).

•Static data creation, review and approval of master data (Product specifications and Test methods in LIMS).

•Lot creation for testing of the samples.

•Review of Analytical results accurately in LIMS.

•Review of Tests, Samples and Lots (Routine analysis data); Lot Approval, Disposition and Release in LIMS.

•Responsible for troubleshooting of routine issues.

•Responsible for training to the Quality control team members related to LIMS application and relevant SOPs.

•Responsible for executing tasks and producing deliverables as outlined in the project plan.

•Responsible for effectively and accurately communicate relevant project information to the end users.

•Responsible for contributing to overall project objectives and specific deliverables.

•Responsible for review of relevant SOPs and coordinate with team members to revise the SOP if required.

•Acting as SME for technical aspects related to functionalities for application.

•Responsible to configure (creating workflows, analytical test methods and analytical specifications) and support LIMS analysis, test lists and other LIMS static data as needed.

•Knowledge of Labware sample life cycle.

Trackwise Specialist (Trackwise):

•Responsible for Trackwise creation, execution and closure of Change control, Deviation, OOS and CAPA. Assisting and supporting to resolve laboratory incidents, OOS, Complaints, Discrepancies and CAPAs.

•Assisting, supporting and participating in nonconformance’s / discrepancies (incident, deviation), out of specification to ensure that the root cause (well versed with RCA tools) is appropriately identified, and robust CAPA taken. Preparation, Reviews and approves investigation and CAPA reports to ensure that documentation is complete and consistent to meet the regulatory requirements.

•Ensure implementation of CAPA and its effectiveness review.

Previous Employer:

Indian Immunological Limited (IIL):

“Indian Immunological Limited” is involved in research and manufacturing of various human vaccines and Animal Vaccines. Indian Immunologicals was setup by The National Dairy Development Board (NDDB). IIL started manufacturing human vaccines in 1998 at the specific request of the Government of India. IIL is the second company in the world and first in India to launch the purified Vero cell rabies vaccine (PVRV) with the brand – Abhayrab. IIL supplying DTP, TT, Hepatitis B to the Government of India and got license for manufacturing of Pentavalent.

Projects handled in IIL–

Handling and monitoring testing methods of DTP (Diptheria, Tetanus & Pertussis), Pentavalent (DTP, Hepatitis B & Haemophilus influenza type b), Hib, Typhoid Polysaccharide, Typhoid conjugate vaccine, Hepatitis A & B, Chikungunya & Rabies

Job Responsibilities in Quality Control Department (Biochemistry & Instrumentation):

•Method Validation done for Pentavalent by Ion Chromatography (DIONEX) for total and free polysaccharide determination.

•Method Validation of Molecular size distribution, DMAP and free protein content was done for PRP & PRP-TT by HPLC.

•Testing of Typhoid Polysaccharide (total and free Vi-Ps) by HPAEC_PAD method using Ion Chromatography (DIONEX), and Molecular size distribution by SEC-HPLC, Free TT, 2-Phenoxy ethanol, O-acetyl content, CTAB, EDAC, ADH, Protein content and Nucleic acid for Production batches.

•Involved in technology transfer from R&D to QC for Typhoid testing methods like Vi Polysaccharide content by HPAEC-PAD (Dionex), Free protein estimation by SEC-HPLC, Molecular size distribution by SEC-HPLC, 2-PE, O-acetyl content, CTAB, EDAC, Protein content (BCA and Micro-BCA), and Nucleic acid .

•Responsible for calibration of HPLC.

•Responsible for product related complaints.

•Handling of the Quality Management tools like Change Control, Deviations, CAPA and Out of specification (OOS).

•Preparation of Protocols and Reports for Validation of Analytical techniques.

•Preparation of documents like SOPs, STPs and PSF & Summary protocols.

•Responsible for preparation of COA and Batch release.

•Responsible for reviewing the Raw Data Sheets of test methods.

•Responsible for preparation of monthly report.

•Protein estimation using Lowry method, Coomassie method and BCA method.

•SDS-PAGE for proteins (Hepatitis B and Adult Bovine Serum).

•Responsible for CSV activities in QC.

Previous Employer:

United States of Pharmacopeia (USP):

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide.

Projects handled in USP–

Successful Completion of monographs for Hepatitis B, Hib-TT, Tetanus, Diphtheria, Pertussis (whole cell) bulks, DTwP, Pentavalent vaccines, Meningococcal A polysaccharide and Meningococcal A Conjugate vaccine.

Successful completion of Reference Standard development for Hepatitis B antigen by SEC-HPLC, SDS-PAGE and ELISA (Abbott Architect Platform).

USP-NF projects: Monograph modernization of Lactase and Trypsin.

Collaborative RS study for Interferon beta-1A, rAlbumin, Collagenase –I & II, Insulin Pork, Goserelin Acetate and Goserelin Related Compound A Biosimilars Handled: Filgrastim and Pegfilgrastim.

Successful completion of Reference Standard development for Pegfilgrastim by SEC-HPLC, RPHPLC, Peptide mapping, Protein Content, and SDS-PAGE (Silver Staining and Coomassie).

Job responsibilities in USP:

•Involved in method validation studies related to TT, DT, Pertussis (whole cell),Hepatitis B, Haemophilus influnzae type B, DTwP, Pentavalent, Meningococcal A polysaccharides and conjugate vaccine monographs.

•Developed and validated the method for estimating the total and free Polysaccharide content in Meningococcal A conjugate vaccine and Meningococcal A Ps by Phosphorous assay.

•Developed and validated the method for estimating the O-acetyl content, nucleic acid and protein content in Meningococcal A Ps bulk by spectroscopic method.

•ELISA by Abbott Architect platform for Hepatitis B antigen.

•Operation & validations on DIONEX HPAEC-PAD for total and free polysaccharide determination.

•Operation & validations on Waters HPLC (RP, SEC) for various purity determinations in vaccines.

•Developed and validated the method for assigning opacity units for Pertussis bulk by spectroscopic method.

•Developed and validated the method for estimating the residual formaldehyde in TT,DT, DTwP & Pentavalent vaccine by spectroscopic method.

•Executed the assay for determining the polysaccharide molecular size and distribution by HPSECUV/MALLS/RI.

•Performed molecular size distribution by LPLC (AKTA prime) for Meningococcal A polysaccharide.

•Involved in collaborative studies for developing USP-vaccine Reference Standard of Hepatitis B and Meningococcal A Polysaccharide in a collaborative study involving USP and NIBSC.

•SDS-PAGE for proteins (Hepatitis B).

•Lf test by Ramson assay for TT and DT.

•Slide agglutination test for Pertussis, DTwP and Pentavalent.

•Identity test for PRP by Wellcogen kit.

•Protein estimation using Lowry method, Coomassie method and BCA method.

•Responsible for reviewing the collaborative study protocols and planning for execution of the protocol to develop the USP-vaccine Reference Standards.

•USP-NF activity: Monograph modernization

•Collaborative studies with USP-Rockville and other labs for establishment of Reference Standards.

•Peptide mapping and Glycan analysis of monoclonal antibodies.

•N-terminal analysis for various protein samples.

•Protein secondary structure determination by Circular Dichroism (CD) spectrometry.

•Capillary electrophoresis (Reducing and Non-reducing) for Immunoglobulin G (IgG)

•Executed the assay for determining the low molecular weight impurity in IgG by HPSECUV/MALLS/RI.

•Executed the assay for Collagenase – I & II using Low Pressure Liquid Chromatography (LPLC)

•Establishment of Virology lab.

Previous Employer:

BIOLOGICAL E.LIMITED

•“Biological E. Limited” is involved in research and manufacturing of various human vaccines and pharmaceutical products. Biological E has been prequalified as a JE and Pentavalent (Reconstituted & Liquid) Vaccine supplier by the WHO.

•Japanese encephalitis vaccine is a Purified inactivated viral vaccine (JE-PIV).

Job Responsibilities in Quality Control of Japanese encephalitis (JE) vaccine:

•Involved in the technology transfer from process Development to cGMP manufacturing.

•Tested five consistency JE production batches & three commercial Batches.

•Prepared cell and seed banks for Vero cells and JE virus.

•Performed aseptic media simulation studies for DS/DP final process filtration.

•Prepared documents like SOPS, LCRS, and PSF & Summary protocols.

•Revival, Passaging, Preparation of 6-well plates for Plaque and PRNT Assays

•Cell Lines Handled: Vero, MRC-5, ST-cells, BT-Cells, LLCPK1, and MDBK & HeLa.

•Plaque assay for enumeration of virus

•Plaque Reduction Neutralization Test (PRNT)

•Haemagglutination Assay

•Adventitious virus testing for JEV

•SDS-PAGE, Western Blot & Protein Estimation by Bradford Assay

•Knowledge of cGMP.

•21 CFR part part 11 and computer system validation (CSV)

Equipments Handled:

•MALLS / RI (Multi Angle Laser Light Scattering and Refractive index), Wyatt Corp (Software: Astra)

•Dionex-ICS 5000 / 5000+ (Software: Chromeleon 6.8)

•Waters HPLC-2695 with PDA, RI, UV/VIS, Fluorescence Detectors (Software: Empower 3).

•Agilent HPLC – 1260 (Software: Chromeleon 7.2 SR 5)

•Protein Simple - Maurice

•Shimadzu HPLC prominence (Software: LC Solution)

•Capillary Electrophoresis with UV and PDA – PA 800 / PA800 Plus-Beckman Coulter (Software:

32 Karat).

•Lambda UV / Vis Spectrophotometer - Perkin Elmer & Shimadzu.

•Versa Doc system-Bio-Rad(Software: Quantity One & Image Lab)

•Circular Dichroism – JASCO J-815 (Software: Spectra manager)

•Protein sequencer – Shimadzu PPSQ-31A

•Low Pressure Liquid Chromatography (AKTA Pure) (Software: Unicorn)

•FTIR – Perkin Elmer

•AKTA Prime (Software: Unicorn)

Achivements:

•One of the key contributors to the WHO-prequalification audit for manufacturing of JEV in 2012.

•One of the leading team members in CDSCO audit for manufacturing of JEV in 2011.

•One of the key contributors to the CDSCO audit for manufacturing license of Pentavalent vaccine in 2017.

•Got excellence award for LIMS implementation in Quality control, Biologics of Syngene in 2020.

Extracurricular Activities:

•Successfully completed German Language Course –Junior-I, Junior-II, Senior-I from Ramakrishna Math, Hyderabad

•Pursuing MBA from Indira Gandhi National Open University(IGNOU), New Delhi

Audits:

•US-FDA

•EMA & MHRA

•WHO

•DCGI

•ISO 9001:2008 & ISO 17025:2005

Education:

Course : M.Sc. Microbiology

Percentage of marks : 74

University : Osmania University, Hyderabad

Strengths:

•Hard working & Quick learner

•Team Player

•Good analyzing skills and ability to work independently.

Computer Skills:

•Operating Systems : Windows & C Language

•Microsoft Packages : MS-Office.

•Quality Management Software System : LIMS (Labware), MetricStream, Trackwise,

Nugenesis, Oracle ERP & EDMS (Electronic data management system)

Personal Profile:

Father's Name : Durgaiah

Date of Birth : 13.08.1986

Marital status : Married

Languages Known : English, Telugu, Hindi and German

Declaration:

I hereby declare that the information given above is genuine to the best of my knowledge and belief.

Place : Bangalore (Balachander Dappuri) Date :

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