Profile of Tirumal Rao

CURRICULUM VITAE

Y.Tirumal Rao

Part-1, Plot No.-26, Swethanjali society, Opp- Sachin Towers, Andhnagar,Ahmedabad.-

380015,INDIA,Passport No: K7068372,Phone:+917*********,Email: acenmo@r.postjobfree.com

CAREER OBJECTIVE

Seeking a challenging position in the field of Vaccine and Biopharmaceuticals where I can

efficiently contribute my skills & effort for the growth of organization as well as myself.

Quality Professional:

1

I have Over 11 years of Analytical development (R&D), Technology transfer and Quality

Control department experiences in the biotechnology industries. I have worked on Viral,Recombinant Vaccines and Biosimilar with dozens of successful audits under my belt.

ACADEMIC PROFILE

M.Sc in Biochemistry from Sri Acharya Nagarjuna University Campus secured first Rank,

Andhra Pradesh. (2001-2003)

B.Sc in Botany, Zoology, and Chemistry from Acharya Nagarjuna University secured 68% of

marks, Andhra Pradesh. (1997-2000).

HANDS ON ANALYTICAL INSTRUMENTS:

Particle size analyzer - q-Nano (Make:IZON),Liquid chromatography systems (HPLC&UPLC

(Make-Agilent and Shimadzu),Flow Cytometer (FACS caliber) Make :BD Gel doc image

analyzers (Make-BIO-RAD& UVP),Protein i12 for IEF systems (Make- Biorad, IEF-Phast

system (GE Health care),PCR-Thermal Cycler, Q-PCR (BIO-,RAD, Step oneplus -Applied

bio-system),Spectroscopy methods(UV,-Vis,Fluorescence), Micro plate reader

&Washer,(Make-Molecular device -190, Thermo fisher and Shimadzu),SDS-PAGE

Westernblot,DNA(Casting,Blotting,RunningGradientunits),Make:Biorad,ATTO,

Thermofisher,Osmometer, Conductivity Meter,PH meter, Analytical Balance, Microbalance and

water bath .(Make: Advance instruments, Mettler Toledo, Sartorius)

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Profile of Tirumal Rao

Professional Experience

Employer: M/s Zydus Cadia, Vaccine Technology Center (VTC) Changodar, Ahmedabad,

INDIA, Duration: Sep, 2010 to Till date, Designation: Manager (Head-Analytical R&D)

Organization profile: Zydus Cadila is a fully integrated, global healthcare provider, with

strengths all along the pharmaceutical value chain.. Zydus is the only Indian pharma company

to launch its own patented NCE – Lipaglyn, the world’s first drug to be approved for the

treatment of diabetic dyslipidemia. .

Current Job profile

2

To provide the technical leadership to analytical method development (ADL) team of

Cell culture, Immunology & Biophysical sections

To develop analytical methods of Viral vaccines (Measles,Mumps,Rubella Varicella,

Seasonal flu & Rota vaccines) and Recombinant vaccine candidates (Hepatitis-B, Human

papiloma (HPV16,18,6,11L1), Malaria(MSPFu24,PFf2&CSP).

Lead and guide the analytical and bio analytical team To establishes goals and

objectives for the members of the Analytical and Bio analytical group including evaluations

To Bridge of R & D, Mfg, QA, QC and Regulatory team for Analytics operations.

To prepare and maintenance of documents related to quality control and technology

transfer

To ensure proper maintenance of documents and record related to the group activities

Develop validated protocols for analytical methods (SDS-PAGE, Western Blot,

ELISA, HPLC(RP&SEC),Cell based-CCID50,PFU&Immno fluorescent,Invivo

bioassay,Host cell DNA, HCP).

To develop new assays and analytical/bio analytical methods for the characterization

and evaluation of intermediate and final products

Ensure timely completion of all the projects assigned,growth and development of group

members

Design of stability studies – Freeze thaw cycle, Forced Degradation, Reconstitution

time point of use stability studies as per ICH and USP.

Cell Bank Preparation, Chacterization & Maintenance: -

Cell Bank Preparation – MCB & WCB

Cell Bank Chacterization – Phenotypic & Genotypic Chacterization

Issuance, Consumption, Routine monitoring & maintenance of cell bank

Preparation of SOP & Data sheets for cell banks.

Profile of Tirumal Rao

Identify and Managing outsourced methods

Preparation and Review of Preclinical and Clinical (Phase-I,II&III) dossiers .

Supports equipment/software/method validation and performs re/validation when

necessary and preparation of capex budgets for AR&D department and ensure indenting

and procurements.

Managing of animal testing activities for Technical Development projects

Establishment of Specification in compliance with Regulatory filing for clinical lots

Procurement of International reference materials (NIBSC&EDQM) and Development

of internal reference standards.

Experience -1

Employer: M/s Zenotech Laboratories Ltd, Hyderabad, INDIA. Duration:Oct, 2009 to

Sep,2010,Department: R&D-ADL, Designation : Sr.Executive.

Job profile Handled

3

Planning and development of analytical methods for In process, DS and DP of rHu-

GCSF,PEG-GCSF,GM-CSF&Mabs (Rituxi Mab,Herceptin,Etanercept)

Analysis of Intermediate & Finished Product ( API & Formulation ) :-

Protein Content: - U.V @ 280 nm & Bradford Method.

Electrophoresis: - SDS - PAGE, Silver Staining, Commassie Staining.

Immunodetection: - Western Blotting.

Isoform Distribution: - Capillary Zone Electrophoresis, Iso Electric Focusing.

Peptide Mapping: - For Drug Substance by RPHPLC.

High Molecular weight & Dimmer Content: - For Drug Substance by HPLC.

Host Cell Protein: - HCP ELISA.

Host Cell DNA: - Hybridization method, RT - PCR Based method.

Preparation of Technology transfer documents (TTD).Performing analytical method

validation as per FDA&ICH guidelines.

Experience -2

Employer: M/s Intas Biopharmaceuticals Ltd, Location: Ahmedabad. Gujarat, INDIA.

Duration: 2007 Aug to Oct 2009, Analytical Department (QC), Designation: Executive.

Organization Profile: Intas is a leading, vertically integrated global pharmaceutical

formulation development, manufacturing and marketing company headquartered in India.

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Profile of Tirumal Rao

Intas commercialized 11 biologic products and continues its R&D efforts in chronic disease

areas such as Oncology (Cancer), Rheumatology, Auto-Immune, Nephrology, Ophthalmology

and Plasma derived product based therapies.

Job Profile Handled

4

Effectively lead of In process, DS, DP and stability batches of rHu-GCSF, PEG-GCSF,

EPO, Parathyroid hormone (PTH) and Rituxi mab

Protein Content: - U.V @ 280 nm,BCA, Bradford Method, RPHPLC method.

Electrophoresis:- SDS - PAGE, Silver Staining, Commassie Staining.Immunodetection:

- Western Blotting. Isoform Distribution: - Iso Electric Focusing.Peptide Mapping: -

RPHPLC method.High Molecular weight & Dimmer Content: - SEC-HPLC method.Host

Cell Protein: - HCP ELISA,Host Cell DNA: - QPCR.

Stability Studies & Biosimilar Chacterization :-

Preparation of stability protocols as per ICH guidelines.

Analysis of stability study samples – Drug substance & Drug Product.

Preparation & compilation stability study summary sheets.

Participation in Forced Degradation, Freeze thaw cycle study.

Participation in Chacterization – Biosimilar Chacterization for EMEA filing rHu-

GCSF,EPO

Validation & Calibration:

Analytical method validation-Protein content,SDS – PAGE, Host Cell Protein, Host Cell

DNA,HPLC (RP,SEC)

Participation in Equipment qualification (IQ, OQ, PQ) activity – Supporting role.

Participation in Equipment calibrations – Internal & External Party - Supporting role.

Preparation & review of SOP, STP, SPC, GTP, TDS, ATDS, stability protocols.

Preparation & checking of COA for Intermediate & finished Product – Involved in

batch release activity.

Handling OOS, Change control, Deviation, File note.

Performing of Trend analysis& trouble shoot analysis, Execution of work for analytical

related regulatory queries. Checking up the analytical records and raw data for accuracy and

authenticity.

Active role in Preparation and Handling of Customer & Regulatory audits. authority

(EMEA), WHO -GMP AUDITS, GCC (Gulf control council), MCC (Medical control

council)

Profile of Tirumal Rao

Experience-3

Employer : M/s Human Biological Institute. (a division of Indian Immunological Ltd.,

Hyderabad.) Location: Ooty. Tamil Nadu, Duration :Oct 2006 to July 2007, Department

: Quality Control Designation : Officer- 1

Organization Profile: Indian Immunologicals Ltd. (IIL) was setup by The National Dairy

Development Board (NDDB) in 1982 with the objective of making Foot and Mouth Disease

(FMD) vaccine available to farmers at an affordable price. The technology for FMD vaccine

manufacture was obtained from M/s. Wellcome Foundation Limited, United Kingdom. The

plant in Hyderabad today has a capacity to make 250 million trivalent doses of FMD vaccine

Job profile Handled

5

Responsible for cell culture analysis of Quality control department For Rabies Vaccine.

Analysis and Release of bulk and final product vaccines as per WHO,I.P. E.P

Preparation of COA- Intermediate & Finished product.

Experience-4

6

Employer: Biological - E ltd, Location: Shamirpet, Hyderabad (A.P), India. Department

: Quality Control (Vaccine division), Duration :2003 to Oct2006, Designation: Executive

Organization profile: Biological E limited is a biotechnology company, headquartered in

Hyderabad, India. It specialises in the areas of low-cost vaccine production.

Job Profile Handled

7

Responsible of Physico-chemical analysis for Recombinant (HepatitisB) vaccine.

Purity test by SDSPAGE and western blot for bulk antigen samples

Release of In-vitro relative potency of sterile filter bulks, final blends, final vaccines

PERSONAL PROFILE

Father : Sri. Y.V.Ramanaiah

Date of Birth : 10/08/1980

Location : Onglole, AndhraPradesh,India.

Civil Status : Indian, male, married.

DECLARATION

I hereby declare that the particulars of information and facts stated above are true, correct and

complete to the best of my knowledge and belief.

(Tirumal Rao)

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