Summary
Overview
Work History
Education
Skills
Timeline
Generic
Tirumal Rao

Tirumal Rao

Biopharma/CDMO
Gdańsk

Summary

Summary of Expertise Profile -Leadership and Managerial Experience A quality driven scientific leader with 20+ years of extensive research and development and quality experience spanning biologics industry of biosimilars and vaccines., mRNA, cell and gene therapy Seasoned in analytical product development with experience of ~15 biosimilars across different stages of development with 2 USFDA approved biosimilars, 9 approved by DCGI India and 15 products analytically researched from inception till launch. Had the experience of working with multi-national and global biotech companies QC department head, experience managing the following: multi-site department of 95 individuals (6 managers over diverse areas), multiple vendor release/stability testing sites, multiple global products, oversight for commercial release/stability activities, sample management, new product initiatives ,incoming component/raw materials, and method validation/transfer. Manage QC department budget and yearly capital expenditures. Quality digitalization and Laboratory information management system (LIMS)- Electronic note book (eLN), Lot management ,Logbook, EMP, stability modules (Vendor-Labware and Biovia). Good Document Management System (GDMS), PLA, Empower3, Chem station, SDS RQ and Soft Max pro etc.

Overview

20
20
years of professional experience

Work History

QC representative

M/s
Gdansk
01.2023 - Current
  • LIR, OOS or OOT, Change Control and Deviation through the Track wise and Quality tracking system (QTS) e-tools, flow of quality managements
  • Vendor management
  • LIMS selection (screen/select consultants, develop user requirements for QC and less regulated departments, lead vendor selection process) and phased build out, performed compliance audits and outline monitoring of contract manufacturing and testing facilities and provide oversight for formal stability studies
  • Experience managing all QC activities of multiple vendor sites as well as internal sites responsible for release/stability testing for multiple commercial products
  • Cross Functional
  • Leadership Experience
  • QC representative on Quality Leadership Team, Biopharma Leadership Team, Parenteral Facility
  • Leadership Team , product CMC and several new product initiative teams
  • QC representative on the following teams: LIMS selection/implementation, material review board, change control review board, technical transfer team, OOS/investigation team, QC Roundtable meetings
  • Regulatory submissions
  • Authored/reviewed CMC sections of Annual Product Reviews, Annual Product Reports, BLA
  • IMPD, RCGM, NDA’s, MAA, and other global filings for multiple products
  • Performed and managed data review for CMC regulatory submissions
  • Documentum experience with workflows related to data review, submission review, and electronic submissions
  • On site, Polpharma biologics https://polpharmabiologics.com/, on multiple Review Boards (RB) including change control RB, deviation&CAPA RB
  • Responsible to manage bioassay lab to release monoclonal antibodies cell-based, ELISA biding and inhibition assays method transfers at different site method validation and Release of clinical and commercial Batches and Qualification of methods for residual process derived components, e.g
  • HCP, HCD and Protein L residuals
  • Review of stability plan, report Method Method Qualification method transfer from R&D to QC, Method validation reports, Specifications and COA’s -Review and approve of stability plans , FUST studies, and reports -Implementing the LIMS and SAP enterprise portal, quality modules with global sites
  • Manner -Review/approve quality events, deviations, OOA and support in investigations and corrective actions -Responsible for the site Quality KPI, RFT (Drug Substance, Drug Product, Stability) and commercial QC analytical method performance -Participate in the recruitment of Quality Control team -Provides strategic leadership, direction and support to the people within multiple departments and ensures that they are qualified; achieve a high level of competence; are motivated; and carry out their duties in a safe
  • Interface/Technical quality activities, and response quarries and to handle regulatory inspection from Global Agencies (FDA, MHRA, EMA, Polish GIF)
  • Participate in the recruitment and budgeting of Quality Control team

Senior Manager/ Head

08.2022 - 12.2022
  • Quality Control compliance, ( Bioassay, Stability, validation) Full time CMO

Head, General Manager

CDMO, M/s Stelis BioSource ltd
09.2021 - 04.2022
  • Stelisbiosource.com/ -Lead QC department (6 manager direct reports, with total staff 98 ) for activities related to end-to-end Quality Control Laboratory Operations (Microbiology, Raw materials, Compliance, Analytical service, Bioassay, Stability) incoming component and data management
  • Represented Quality Control on cross-functional department service of Adeno vector-derived covid19 vaccine and biosimilars -Carried out the method validation, implementation, and oversight of QC Analytical testing programs for all stages of the clinical and commercial AAV viral vector and product lifecycle
  • Direct with Analytical Development to ensure in-house methods are properly developed, validated, and installed in the QC Laboratory, ensuring external testing and all aspects of the method lifecycle are appropriately documented
  • Coordinate and communicate CMC input to the (analytical) development strategy & participate in project teams, manage projects (scope, timelines, budget), and manage CDMOs on behalf of clients.

Head

Istanbul
02.2019 - 09.2021
  • Quality Control and Microbiology for Vaccines and Biosimilars, M/s Nobel Bio, CMO
  • Https://www.nobel.com.tr/en-us
  • Reporting to Corporate Quality Director and Board Executive Member
  • Developed and implemented QC systems (SOPs, databases, trending & metrics) to optimize support of stability and release testing for launch of commercial product
  • Led in the development and validation of Sterility, MLT, Disinfectant efficacy, Water qualification
  • Environment Monitoring, Excipient Efficacy testing
  • Technology transfer at the manufacturing site
  • Carried out and managed development/validation/transfer of several analytical methods for covid vaccine and other biosimilar molecules and precursors for pre-clinical and phase I-III studies
  • Special Achievements: - Set-up all aspect of R&D, Manufacturing, and Quality Control laboratory supporting for the release of clinical and commercial manufacturing batches for vaccines and biosimilars -Successfully released preclinical and clinical batches for the Covid19 VLP based vaccine over a period of 4-6 months.

Manager

Analytical R&D, M/s Pfizer
Chennai
02.2015 - 01.2019
  • Www.pfizer.com/ -Develops platform methods and characterize the biophysical methods for protein and process related impurities (SEC, CEX, RP-HPLC, Peptide mapping, CZE, NR&R CGE,CEX ,SoloVPE -UV spectroscopic, HCP,HCD and N-glycan) and transfer to global stockholders
  • Leadership role to review and approve the LIMS- ELN and stability modules data through the LIMS e-tools
  • Successful Implemented Pfizer Quality system harmonization (LIR, OOS or OOT, Change Control and Deviation) through the Quality tracking system (QTS) e-tool -Authorship/reviewer/approver in CMC analytical section (characterization, method development / qualification / validation, specification, comparability, and stability) in IND filing, yearly update and BLA submissions (FDA, EU and JP)
  • Established statistical Data analysis with various Software’s like Gene 5 software, Empower 3, PLA software and 32 karat etc presenting technical data in concise reports
  • Special Achievement
  • Awarded two certificates of achievements and bonuses for Global Quality integration/ harmonization and LIMS implementation.

Manager, QC representative, Scientific officer

D M/s Zydus Cadila, Vaccine Technology Center
Ahmedabad
09.2010 - 01.2015
  • Zyduscadila.com -AD and, , 3 Associate Scientist direct reports, with total staff 15) for activities related to product method development, technology transfer, and investigational trouble-shooting and data management
  • Developed cell culture methods for Thermostable vaccines (Measles, Mumps, Rubella Varicella, Seasonal flu & Rota vaccines) -Established the characterization of Viral seeds, MCB and WCB -Developed methods- Invitro and in vivo assays, CCID 50, Plaque Forming Units(PFU),SRID, Imuno-histochemistry, ELISA, Hyper sera (Mice& Rabbit), Iso-enzyme (cell identity),Immunogenicity screening assay for Pre-clinical& Clinical(Phase-I,II,III) -Developed and implemented QC systems (CQA, SOPs, specifications, QMS trending & metrics) to optimize support of stability and release testing of clinical products Responsible to plan for resources such as manpower, Capex for the lab and the training needs for the team Procurement of International reference materials (USP,NIBSC&EDQM) and Development of internal reference standardisation activities for areas of responsibility including budget, recruitment, development and staff performance
  • Special Achievement
  • Awarded two promotions of achievements for HPV 16&18L1, MMRV preclinical, clinical approvals and Validated method is currently used virus titres assay/impurities release of clinical materials

AD/QC- Senior Executive

M/s Zeno tech laboratories, Sun Pharma
Hyderabad
10.2009 - 09.2010
  • Sunpharma.com/about-us/ -Performed bioassays assays (cell based and ELISA) and impurities ( HCP,HCD, Protein A)
  • Achievements:
  • Successfully managed and trained Bioassay lab of 7-8 members skilled in various techniques for handling cell line and assay like UMR-106, UT-7, NFS-60, WISH and HuVec for the c-AMP bioassay, reporter gene assay, proliferation, cytopathic assay and antiproliferation assay development for the therapeutic proteins
  • Transfer assay from R&D to QC

QC-Executive

Intas Bio pharmaceuticals Limited
Ahmedabad
08.2007 - 10.2009
  • Www.intaspharma.com/ -Executed the daily operations of QC Electrophoresis and chromatography labs (ELISA, HPLC and Gel Methods for GCSF, PEG-GCSF, RituxiMab / rHu EPO

QC-Senior Officer

M/s Human Biological Institute
Ooty
10.2006 - 07.2007
  • Www.indimmune.com/ -Vaccines- Performed Sterility, EMP, bioburden, endotoxin, ELISA, and microbial identifications

QC- Executive

Biological - E Limited
Hyderabad
10.2005 - 10.2006
  • Responsible for regular product QC testing, stability release testing, microbiology testing of recombinant vaccine (Hepatitis B) as per WHO TRS786.Vaccines - Day to day analysis of QC chemical and microbiology labs, primarily bioburden, endotoxin, cell culture, cell bank and microbial identification testing.

Education

Business of Science - Development

M.Sc - Biochemistry

Sri Acharya Nagarjuna University Campus
01.2001 - 1 2003

B.Sc - Botany, Zoology, Chemistry

Sri Acharya Nagarjuna University
01.1997 - 1 2000

Skills

Business growth and retention

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Timeline

QC representative

M/s
01.2023 - Current

Senior Manager/ Head

08.2022 - 12.2022

Head, General Manager

CDMO, M/s Stelis BioSource ltd
09.2021 - 04.2022

Head

02.2019 - 09.2021

Manager

Analytical R&D, M/s Pfizer
02.2015 - 01.2019

Manager, QC representative, Scientific officer

D M/s Zydus Cadila, Vaccine Technology Center
09.2010 - 01.2015

AD/QC- Senior Executive

M/s Zeno tech laboratories, Sun Pharma
10.2009 - 09.2010

QC-Executive

Intas Bio pharmaceuticals Limited
08.2007 - 10.2009

QC-Senior Officer

M/s Human Biological Institute
10.2006 - 07.2007

QC- Executive

Biological - E Limited
10.2005 - 10.2006

M.Sc - Biochemistry

Sri Acharya Nagarjuna University Campus
01.2001 - 1 2003

B.Sc - Botany, Zoology, Chemistry

Sri Acharya Nagarjuna University
01.1997 - 1 2000

Business of Science - Development

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