Experience

HealthCube

• Hospitals and Health Care

• Vice President-QA, RA & Product Delivery

  • May 2022 - Present

  Bengaluru, Karnataka, India



Urgo Medical

• Medical Equipment Manufacturing
• 400 - 500 Employee

• Head- QA, RA, Technical and Clinical Research

  • Jan 2021 - May 2022

  Chennai, Tamil Nadu, India Leading the team of 15 members in QA, QC and RA to support domestic, export and tender business operations.Authorized Management Representative Responsible for Class A,B,C and D Biological Medical Device registration with CDSCO and State Licensing Authority. Responsible for Registrations in 30 Countries including LATAM, EMEA, EU,US and APAC. Maintenance of CE certificates under MDD & MDR 2017/745. Managing ISO 7/8 GMP certified manufacturing unit in Chennai, India



OncoStem Diagnostics Pvt. Ltd.

• India
• Biotechnology Research
• 1 - 100 Employee

• Head-Quality & Regulatory

  • Nov 2019 - Dec 2020

  Bengaluru Area, India Responsible for leading quality systems and regulatory requirements for OncoStem Diagnostics, a company that has developed an IP driven IHC based prognostic test-''CanAssist Breast'' for aiding oncologists in treating their patients optimally. Compliance active to date: KPME, ISO 13485:2016, ISO 15189:2012, CAP and CE-IVD. Pipeline: 510(k) USFDA



Pandorum Technologies Pvt. Ltd.

• Senior Manager-Quality, Regulatory & Facility

  • Dec 2018 - Nov 2019

  Bengaluru Area, India • Guide the company on various clinical trials and regulatory paths for combination products (medical device+biologics), Advanced Therapies and Regenerative Medicine (ATMP) products , IVD (Invitro diagnostics) • Support the company in preparing & submitting dossiers to regulatory authorities to obtain market approvals for various geographies-India, USA, Japan, EU, UK, Singapore, South Korea and Canada • To assist the Directors and management in strategy, operations, business development,… Show more • Guide the company on various clinical trials and regulatory paths for combination products (medical device+biologics), Advanced Therapies and Regenerative Medicine (ATMP) products , IVD (Invitro diagnostics) • Support the company in preparing & submitting dossiers to regulatory authorities to obtain market approvals for various geographies-India, USA, Japan, EU, UK, Singapore, South Korea and Canada • To assist the Directors and management in strategy, operations, business development, market research, PR, IP, legal and para-legal matters • To interact and to represent company for statutory relations, audit firms, CROs and potential investors • To plan, build, commission and operate the state-of-the art medical device manufacturing facility • Interact with state, national and international regulatory experts, notified bodies and competent authorities to understand the necessary regulatory requirements & standards for the company’s newer generation IVDs, ATMP/RMTP, combination products (device+drugs/biologics) • Obtain necessary certifications, accreditations, licenses, and permits for the company • Responsible for establishing, implementing and maintaining various Quality management system (QMS) • Responsible for managing the QA/RA team and guiding them in preparation of quality manual and other documents like policies, procedural manuals for users, work instructions, SOPs and training materials related to CLIA, ISO 15189/NABL, ISO 9001,13485, 14644,14971, CAP, GLP, and cGMP standards • Establish, plan and conduct periodically internal audits and perform gap analysis as required • Prepare annual training calendar & competency evaluation programs for the employees • Provide OSHA, HIPPA training to company employees and conduct safety audits • Coordinate regulatory, second/third-party inspections • To work across the company to align new R&D initiatives, IP and support business strategy • Travel (domestic & international) as necessary for the company meetings Show less



Mitra Biotech

• United States
• Biotechnology Research
• 1 - 100 Employee

• Manager-Quality & Regulatory

  • Jul 2011 - Nov 2018

  Greater Boston Area, USA Responsibilities in brief: • Supporting clinical studies and biopharma projects • Overall laboratory operations for scientific operations • New facility set up, cost reduction and lab automation • CLIA, CAP accreditation/certifications, cGMP compliance etc. • Out of State CLIA (RI, PA, FL) licensures • Developing Policy & Procedures and implementing QMS (Quality Management Systems) • Change controls, CAPA and NCR report • Data collection and analysis and continual… Show more Responsibilities in brief: • Supporting clinical studies and biopharma projects • Overall laboratory operations for scientific operations • New facility set up, cost reduction and lab automation • CLIA, CAP accreditation/certifications, cGMP compliance etc. • Out of State CLIA (RI, PA, FL) licensures • Developing Policy & Procedures and implementing QMS (Quality Management Systems) • Change controls, CAPA and NCR report • Data collection and analysis and continual improvement • Risk Management assessment of LDT/IVDs • Laboratory team meeting & training (HIPAA, OSHA etc.) • EQA (External Quality Assurance) and PT (Proficiency Testing) management • Conducting internal audits in the laboratory and facing external regulatory audits • Validation of tests (Digital pathology, molecular tests, live cell-based assays), instruments and process • LIMS (Laboratory Information Management System) • Technical File construction and regulatory dossier preparation • CE marking and IDE (Investigational Device Exemption),510K for USFDA • Customer inquiries and SalesForce tool handling • EDC (Electronic Data Capturing) Technical competencies: 3D co-culture using organotypic inserts, In-vitro assay development (viability, cell death, proliferation, apoptosis, metabolic, cytotoxicity), primary cell line generation, drug repurposing, multiplexing of high throughput assays using automated liquid handler, HUVEC tube formation assay, Serum free adaptation, Isolation of PBNCs, Spheroid & Organoid culture using hanging drop method, Endotoxin assays, EGF/HGF ELISA, chemo-sensitivity and resistance assays in solid and liquid cancers. Show less



Consiglio Nazionale delle Ricerche

• Italy
• Research Services
• 700 & Above Employee

• Scientist

  • Jan 2007 - Dec 2010

  Pisa,Italy Studied HIV-1 viral Integration and its association with its cellular cofactors viz. Trim 28,LEDGF/p75 etc. Core competencies:Transfection with HEK 293-T cells, S35/C14 labeled histone inhibitor acetylation assays, Alpha screen assays, Gene cloning, site directed mutagenesis, In-vitro coupled transcription and translation, SDS PAGE and western blotting, Yeast two hybrid screening, recombinant protein expression, purification with trouble shooting skills, Chromatography:IMAC (Ni-NTA)… Show more Studied HIV-1 viral Integration and its association with its cellular cofactors viz. Trim 28,LEDGF/p75 etc. Core competencies:Transfection with HEK 293-T cells, S35/C14 labeled histone inhibitor acetylation assays, Alpha screen assays, Gene cloning, site directed mutagenesis, In-vitro coupled transcription and translation, SDS PAGE and western blotting, Yeast two hybrid screening, recombinant protein expression, purification with trouble shooting skills, Chromatography:IMAC (Ni-NTA) His, GST, GFP,FLAG tags. Protein-protein interaction studies using pull down assays and co-IP, peptide competition assays,Bradford, BCA,Lowry assays and Autoradiography- phosphoimaging typhoon. Expression analysis by flow cytometry. Show less



Madurai Kamarajar University

• India
• 1 - 100 Employee

• Research Fellow

  • Nov 2005 - Dec 2006

  Madurai Area, India Worked on molecular analysis of mce1A gene of Mycobacterium Leprae. Codon optimization and microarray data analysis using AVADIS. Bioinformatics tools: Vector NTI, Sequencher.



Freelance, self-employed

• Animation and Post-production
• 1 - 100 Employee

• Independent Consultant

  • Jan 2004 - Oct 2005

  Puducherry, India Managed KPO projects in Bioinformatics & Pharmacogenomics