MANOJKUMAR JAYABAL
Dundalk,Ireland
Summary
Biologics leader with over 12+ years of expertise in process development, technology transfer, and lifecycle management of biologics products. Demonstrated success in executing technology transfers, process validation, and regulatory support in both development and commercial settings. Skilled in driving process improvements, leading cross-functional teams, and translating
Overview
12
12
years of professional experience
Work history
Senior Scientist – MSAT Technology Transfer
WuXi Biologics
Dundalk, Ireland
2024.04 - 2026.06
- Led end-to-end upstream technology transfer planning for commercial biologics programs.
- Conducted process fit-gap assessments, risk assessments, and validation readiness checks.
- Executed PPQ activities and completed manufacturing readiness documentation for transfer packages.
- Provided technical leadership for media preparation, upstream processing, and harvest operations.
- Coordinated mixing studies and delivered manufacturing support during commercial execution.
- Led technical investigations, including root cause analysis, deviation management, and Capa implementation.
- Supported commercial manufacturing campaigns and ongoing lifecycle process monitoring activities.
- Authored and reviewed PPQ protocols, validation reports, and risk assessments.
- Prepared process transfer documentation and GMP technical reports for audit readiness.
- Optimised buffer mixing, delivering €276000 annual operational savings for manufacturing.
- Prepared for HPRA and regulatory inspections through inspection readiness activities.
- Collaborated with manufacturing quality, validation engineering, supply chain, and global MSAT stakeholders.
Associate Manager – MSAT
Biocon Biologics
Bangalore, India
2023.01 - 2024.03
- Led scientists and engineers supporting commercial manufacturing and lifecycle management activities.
- Drove process optimisation and scale-up to achieve 15% productivity improvements.
- Owned investigations resolving critical slow-growth manufacturing challenges affecting supply.
- Directed process monitoring, validation support, and technical assessments for root causes.
- Coordinated technology transfer and commercialisation activities for late-stage and commercial products.
- Represented MSAT in regulatory inspections and technical review forums.
MSAT Lead / Upstream Process Development Scientist
Kemwell Biopharma
Bangalore, India
2017.01 - 2023.01
- Owned technology transfer programmes from client organisations into development and GMP facilities.
- Directed process characterisation, validation, PPQ execution, and commercialisation support.
- Established site’s first CPV programme for commercial biologics product.
- Coordinated client engagement during regulatory inspections, investigations, and manufacturing troubleshooting.
- Drove statistical process analysis and monitoring strategies to improve control and robustness.
- Held accountability for validation protocols, process development reports, risk assessments, and transfer documentation.
Senior Executive / Executive – Upstream Process Development
Biocon Research Limited
Bangalore, India
2014.05 - 2017.01
- Develop upstream processes using CHO and NS0 platforms daily.
- Conduct scale-up and scale-down optimisation, characterisation, and robustness studies.
- Support process transfer readiness and deepen manufacturing process understanding.
Education
M.Tech - Quality Management
BITS Pilani
IndiaB.Tech - Biotechnology
Anna University
IndiaSkills
- MSAT Leadership
- Technology Transfer & Scale -Up
- Upstream Processing
- Commercial Manufacturing
- Process Performance Qualification (PPQ)
- Continued Process Verification (CPV)
- Lifecycle Management
- Regulatory Inspections
- Risk Assessments
- Stakeholder Management
- Cross-Functional Leadership
- Client Management
CAREER HIGHLIGHTS
- Led or significantly supported 6 biologics technology transfers from development into GMP manufacturing.
- Successfully executed and supported 4 PPQ campaigns for commercial biologics manufacturing.
- Supported lifecycle management and commercial manufacturing activities across 6 commercial biologics products.
- Delivered approximately 15% manufacturing productivity improvement through process optimization and successful implementation at commercial scale.
- Led a Kaizen-driven buffer mixing optimization project generating an estimated annual cost saving of €276,000.
- Resolved critical commercial manufacturing slow-growth issues, enabling uninterrupted product supply and maintaining manufacturing continuity.
- Designed and implemented the first Continued Process Verification (CPV) program for a commercial biologics DS manufacturing
- Supported successful HPRA and FDA regulatory inspections through technical leadership, audit preparation, and response management.
- Delivered technical presentations and represented MSAT teams in client-facing discussions across multiple biologics programs.
- Led and mentored scientists while driving cross-functional collaboration across Manufacturing, Quality, Validation, Regulatory Affairs, Engineering, and Supply Chain functions.
CORE Competency
Technical leader recognized for combining deep biologics manufacturing expertise with strong stakeholder engagement, cross-functional influence, and business-focused problem solving. Passionate about building robust manufacturing processes, enabling successful commercialization, developing technical talent, and driving continuous improvement across global biopharmaceutical operations.
Awards & Recognitions
- Outstanding Employee Award – WuXi Biologics (2025)
- Excellence Cup Winner – WuXi Biologics (2025)
- Multiple Performance Excellence Awards across Biocon and Kemwell Biopharma
Timeline
Senior Scientist – MSAT Technology Transfer
WuXi Biologics
2024.04 - 2026.06
Associate Manager – MSAT
Biocon Biologics
2023.01 - 2024.03
MSAT Lead / Upstream Process Development Scientist
Kemwell Biopharma
2017.01 - 2023.01
Senior Executive / Executive – Upstream Process Development
Biocon Research Limited
2014.05 - 2017.01
M.Tech - Quality Management
BITS Pilani
B.Tech - Biotechnology
Anna University