AMIT KUMAR SRIVASTAVA
Slough
Summary
Senior MSAT leader with over 20 years of expertise in biologics manufacturing, technology transfer, and product lifecycle management. Proven track record as a technical decision maker, delivering independent scientific judgment on process changes and validation strategies that enhance quality compliance and ensure supply continuity. Extensive experience in leading regulatory inspections and managing change control while advising senior leadership across mammalian and microbial platforms.
Takes on challenging new role harnessing interpersonal skills, collaboration and problem-solving. Driven to deliver high-quality service and consistent results.
Overview
25
25
years of professional experience
6
6
years of post-secondary education
1
1
Certification
Work history
Senior Principal Scientist – MSAT
Lonza
Slough
2019.05 - 2026.05
- Provide site-level MSAT leadership as subject matter expert and for technology transfer, process scale-up (Lab scale, pilot to GMP scale), complete planning for PPQ campaign (Protocols, Various studies to support PPQ, Reports), and commercial manufacturing.
- Exercise scientific judgement on process changes, validation approaches (leading discussion with customers on strategy), process risk assessments control strategy, and product lifecycle decisions.
- Lead MSAT engagement during regulatory inspections and customer audits, including preparation, technical defence, and response approval.
- Serve as MSAT change assessor, governing risk-based change implementation impacting quality, safety, and supply.
- Lead complex cross-functional technical escalations, deviation investigations, and systemic CAPA implementation.
- Approve validation strategies, PPQ reports, CPV/APR narratives, batch records, and critical GMP documentation.
- Mentor MSAT scientists and influence technical decision quality across Manufacturing, Quality, Engineering, and Regulatory teams.
Senior Manager (Upstream Lead) – Manufacturing Science & Technology
Syngene International Ltd.
Bengaluru
2016.09 - 2019.04
- Served as MSAT lead for upstream process scale up of mammalian cell culture (10 L-2 kL SUB) and microbial fermentation (20 L - 200 L SS) processes.
- Defined bioreactor design space (kLa, mixing, heat transfer) enabling first-time-right commercial execution.
- Led technology transfer of eight products from lab to GMP manufacturing with full risk ownership.
- Senior technical interface for global clients during governance and regulatory interactions.
- Drove cross functional collaboration across Development, Manufacturing, Quality, and Engineering to resolve scale up and manufacturing challenges.
- Eliminated chronic contamination failures (100% → sustained zero) and received Individual Contributor Award.
Manager – Manufacturing Technology & Process Analytics
Dr. Reddy’s Laboratories – Biologics
Hyderabad
2015.01 - 2016.01
- Led commercial MSAT support, CPV implementation, and capability analysis for biosimilar products (3 commercial products, mAbs).
- Implemented continuous process monitoring and capability (Cpk) analysis to identify trends, risks, and improvement opportunities
- Provided lifecycle improvement leadership across upstream and downstream interfaces.
Manager – Manufacturing Technical Services
Dr. Reddy’s Laboratories – Biologics
Hyderabad
2012.05 - 2015.04
- Led technology transfer of two biosimilar mAb products from laboratory to pilot scale (3 L to 200 L).
- Delivered scale-up of fed-batch mammalian cell culture to 1 kL production scale, meeting quality and productivity targets.
- Led deviation investigations, CAPA, and change control to sustain GMP compliance.
- Established scale-down models to support investigations, process understanding, and raw-material qualification.
- Authored and reviewed process validation, campaign review, and investigation reports.
- Key Achievement: Awarded Stellar Award for significant reduction in process variability and improvement in product titers
Deputy Manager – Manufacturing
Dr. Reddy’s Laboratories – Biologics
Hyderabad
2007.07 - 2012.05
- Manufacturing team lead for bacterial fermentation and mammalian cell culture operations across multiple production trains.
- Performed process characterization and capability analysis to improve robustness and define operating ranges.
- Supported global and local regulatory audits, including technical responses and shop-floor explanations.
- Drove contamination reduction initiatives, achieving a sustained reduction from ~36% to ~2% across commercial batches.
- Mentored manufacturing teams to strengthen GMP execution and operational discipline.
Production Executive, Manufacturing
Shantha Biotechnics Ltd. (Sanofi Group)
Hyderabad
2006.08 - 2007.07
- Supported cell culture, fermentation, and downstream processing for recombinant Hepatitis B Surface Antigen (HBsAg) expressed in Pichia pastoris.
- Conducted root-cause analysis of contamination and operational issues, reducing batch failure rates from 24% to 11%.
- Trained and coached shop-floor teams to improve operational consistency and compliance.
Process Superintendent – Manufacturing
United Breweries Ltd. (BGIL)
Baramati
2001.06 - 2004.06
- Managed fermentation and distillation plant operations, ensuring safe, efficient, and consistent production.
- Management Representative for ISO 9000, leading internal and external audits.
- Delivered operational efficiency improvements, including reduced energy and steam consumption and improved ethanol recovery
Education
M.Tech - Bioprocess Technology
UDCT (ICT)
Mumbai, India 2004.07 - 2006.06
B.Tech - Chemical Engineering
HBTI
Kanpur, India 1997.07 - 2001.05
Skills
- MSAT Strategy, Governance & Technical Decision Making
- Cross-Functional & Executive Stakeholder for Global Harmonization across sites
- Global Technology Transfer (Clinical to Commercial) at various scale Upto 2K
- GAP Assessments, Process Validation (PPQ), CPV & Product Lifecycle Management
- FMEAs, Control Strategy, Risk Assessment & Change Governance
- Regulatory Inspection for FDA, EMA, MHRA, PMDA, China
- Manufacturing Reliability, Deviations & First Time Right
- Advanced Process Analytics (JMP, SIMCA, PI)
- Problem-solving
- Communication skills
- Change Management
Certification
- Certified Internal Auditor
- Advanced Training: Multivariate Data Analysis, GMP Inspections
Affiliations
- Avid Cricket fan
- Regular Badminton Player
Languages
English
Fluent
Timeline
Senior Principal Scientist – MSAT
Lonza
2019.05 - 2026.05
Senior Manager (Upstream Lead) – Manufacturing Science & Technology
Syngene International Ltd.
2016.09 - 2019.04
Manager – Manufacturing Technology & Process Analytics
Dr. Reddy’s Laboratories – Biologics
2015.01 - 2016.01
Manager – Manufacturing Technical Services
Dr. Reddy’s Laboratories – Biologics
2012.05 - 2015.04
Deputy Manager – Manufacturing
Dr. Reddy’s Laboratories – Biologics
2007.07 - 2012.05
Production Executive, Manufacturing
Shantha Biotechnics Ltd. (Sanofi Group)
2006.08 - 2007.07
M.Tech - Bioprocess Technology
UDCT (ICT)
2004.07 - 2006.06
Process Superintendent – Manufacturing
United Breweries Ltd. (BGIL)
2001.06 - 2004.06
B.Tech - Chemical Engineering
HBTI
1997.07 - 2001.05