Veena A. Pai Raiker
Pune
Summary
Having a successful career by leveraging my real time experience in the Biotechnology/Life sciences domain. I believe I have a deep customer understanding in my area, which in turn can help any organization in delivering immense customer value.
Overview
21
21
years of professional experience
Work History
Head, Project Management
Enzene Biosciences Ltd.
11.2017 - Current
- Spearheading a team of 8 Project Managers for tracking and timely deliverables of all verticals in the Company (Biosimilars, Biologics, Clinical, CDMO/CMO, Launch management)
- Handling around 20 client projects (biologics) at various stages from early research to commercial including integrated projects (R&D to GMP inclusive of supply chain, operations and delivery) successfully leading to positive client relationship outcome. Directly responsible to ensure customer satisfaction and effectively manage alliances with key accounts
- Contributed towards launch of 7 biosimilar products in domestic markets and 2 product submissions in global territory (EMA & USFDA)
- Implemented IPECC model with all framework and the required documentation along with Change management processes for Project Management
- Expertise in strategic planning, risk assessment and mitigation strategies to minimize potential issues during project execution
- Partner with Finance and Procurement to ensure accurate forecasting, tracking and compliance with company policies
- Collaborating closely with CEO’s Office & Senior Leadership Team to align project objectives with company initiatives, ensuring that efforts contributed to overall business growth
- Responsible for monthly MIS to management and Board for accurate information
- Implemented metric visualization on dashboard for insights into the success of the project
- Directly involved with Proposal Team to develop timelines based on RFPs and expectations received from clients
- Collaborate effectively across diverse cultural environments and manage operations across multiple global timezones
- Program & Alliance Management
- Technical SME, Program Management
- Quality Control (Jan 2020 – Jul 2022)
- R&D (Nov 2017 – Dec 2019)
Principal Scientist
Lupin Limited (Biotech)
07.2008 - 12.2016
- Independently set up R&D mammalian cell culture lab (Class 10000 with biosafety cabinets) along with validation of the same as per ICH guidelines. Performed equipment and vendor evaluation followed by complete qualifications.
- Set up a system to track maintenance and proper functioning of the equipment along with the clean room lab. Responsible for keeping the lab and the systems audit-friendly.
- Developed routine release and characterization cell based assays for more than 10 therapeutic products derived from microbial and mammalian sources to elucidate mechanism of action and to demonstrate comparability to innovators product
- Formats developed - Proliferation, Cell death, Ligand neutralization, Signal transduction, Complement dependent cytotoxicity (CDC), Antibody-dependent cell cytotoxicity (ADCC – Classical and Reporter gene assays), inhibition of virus-induced cytopathic effect, cell differentiation. These assays were developed using various detection methodologies like absorbance, fluorescence, luminescence, TRF/HTRF
- Developed precise (
- Transferred an assay protocol (higher S/N ratio) for inhibition of proliferation assay to United States Pharmacopoeia, India
- Participated in qualification of NIBSC reference standard for PegGCSF and Etanercept establishing assay consistency from global point of view.
- Facility Management
- Research Activities
Executive Scientist, Cell Culture Dept.
Yashraj Biotechnology Limited
05.2005 - 04.2008
- Independently setting up an R&D mammalian cell culture facility along with a manufacturing facility designed as per US-FDA standards.
- Initiating research projects for cell-derived antigens and polyclonal as well as monoclonal antibodies for diagnostic purposes.
- Writing Grant Proposals and Execution of new Projects.
- Facility Management
- Research Activities & Others
Education
Ph.D. - Applied Biology (Immunology)
University of Mumbai
Mumbai, India05.2005
M.Sc. - Lifesciences-: Biotechnology
University of Mumbai
Mumbai, India05.1999
B.Sc. - Microbiology-: Biotechnology
University of Mumbai
Mumbai, India03.1997
Skills
- Multifaceted and result driven professional with around 20 years of experience in various commercial (Project Management & Alliance Management), quality and research activities in biologics industry Experience of working with international clients (Sponsors) from various geographies on different pharma & biological projects
- In-depth understanding of technical domain along with sound administrative duties Ability to take on challenges with confidence with proven experiences in turn-around of key projects from red (worse) to green (excellent) status
- Very strong analytical skills with sharp eye for details and exact know-how to navigate through difficult problems and come up with a solution Knowledge of softwares for Project & Alliance Management (Zoho, Smart Sheets, MS Office) and for technical domain (Parallel Line Analysis) A penchant for solving problems with high logical thinking
- Strong scientific writing skills including regulatory write-ups and research papers to achieve clarity on projects Excellent teaching/training capabilities with focus on example driven projects and thesis Successful deliverables in track record time and faced client and regulatory (national and international) audits successfully
- Robust understanding of people and teams; ability to connect with people from different backgrounds and across levels with ease and confidence; excellent verbal and written communication skills including presentation skills
- 10 Professional publications in national and international peer reviewed scientific journals including one international patent
Languages
English
Hindi
Marathi
Konkani
Timeline
Head, Project Management
Enzene Biosciences Ltd.
11.2017 - Current
Principal Scientist
Lupin Limited (Biotech)
07.2008 - 12.2016
Executive Scientist, Cell Culture Dept.
Yashraj Biotechnology Limited
05.2005 - 04.2008
M.Sc. - Lifesciences-: Biotechnology
University of Mumbai
B.Sc. - Microbiology-: Biotechnology
University of Mumbai
Ph.D. - Applied Biology (Immunology)
University of Mumbai
AWARDS/HONOURS
Invited Speaker at 8th International Bioprocessing India Conference (Dec, 2022) Title: Establishing physico-chemical & functional comparability for a biosimilar Mab: A Case Study, Expert member in United State Pharmacopoeia’s Expert Panel (2016) for contributing in writing a general chapter on Fc Receptor Assays., Invited Speaker at Emprove Seminar Series (June, 2015) at Bangalore, India. Title: “Bio-Characterization of Biosimilars”., Invited Speaker at United State Pharmacopoeia’s 6th Bioassay Workshop (June, 2014) at Rockville, Maryland. Title: “Inter-lab transfer of bioassays: Potential pitfalls, risk analysis and solutions”., “Partners in Progress” (awarded in 2011) by Lupin Limited, India., Senior Research Fellowship (2001-2004), Department of Atomic Energy, Government of India., Junior Research Fellowship (1999-2001), Department of Atomic Energy, Government of India.
PUBLICATIONS/PATENTS
Can be provided if required
Details
- Date of Birth: 19th September 1977
- Marital Status: Married
- Date: 12th Nov 2025
Hobbies and Interests
Reading, Listening to music