Manoj Kumar, PhD

Biopharmaceutical downstream processing expert with a Ph.D. in Biotechnology and 17+ years of academic and industrial experience, with proven success in purification, scale-up, and technology transfer of biosimilars, monoclonal antibodies, recombinant proteins, vaccines, fusion proteins, and pDNA platforms. Specialized in solving complex purification and refolding challenges through DoE-driven process optimization, GMP-compliant tech transfer, impurity clearance, and manufacturing troubleshooting across microbial and mammalian expression systems. Recognized project leader with a strong record of accelerating client delivery timelines, enabling robust commercial manufacturing processes, and driving high-impact biologics programs in leading global biopharma organizations.

Principal Scientist (Sr. Manager) - SYNGENE INTERNATIONAL LTD

(2022-04)

• Spearheaded end-to-end downstream process development for biologics including mAbs, biosimilars, fusion proteins, recombinant proteins, vaccines, and pDNA platforms.
• Directed client-facing technical communications and provided strategic scientific leadership for complex global projects.
• Accelerated process scale-up and GMP tech transfer by resolving critical purification and manufacturing bottlenecks.
• Led high-impact project execution through robust planning, risk mitigation, and cross-functional coordination.
• Delivered strategic scientific evaluations and process improvement recommendations for multiple development programs.

Senior Scientist - MYNVAX PRIVATE LIMITED

(2021-11 - 2022-03)

• Managed integrated upstream and downstream process development for recombinant vaccine candidates.
• Established efficient insect cell-based protein expression and purification workflows for vaccine development.

Research Scientist - INTAS BIOPHARMACEUTICALS LIMITED

(2019-07 - 2021-10)

• Led downstream purification and impurity clearance strategies for early and late-stage biosimilars.
• Drove successful process scale-up and manufacturing integration through seamless technology transfer execution.
• Implemented process robustness and continuous improvement initiatives to enhance product quality and consistency.
• Supported GMP manufacturing campaigns, engineering batches, CT campaigns, through direct technical supervision.
• Mentored emerging scientists and delivered industrial training programs focused on bioprocess development excellence.

Assistant Manager - AUROBINDO PHARMA LTD OR CuraTeQ BIOLOGICS

(2016-07 - 2019-07)

• Executed purification process development and scale-up activities for biosimilar programs from R&D to manufacturing scale.
• Optimized site-specific PEGylation processes to improve protein conjugation efficiency and product performance.
• Led depth filtration and TFF sizing studies for multiple large-scale biologics projects.
• Authored comprehensive process development reports and manufacturing support documentation for engineering batches.
• Facilitated cross-functional technical reviews and streamlined project communication through structured coordination meetings.

Research Associate - VIRCHOW BIOTECH PVT. LTD.

(2009-01 - 2011-01)

• Developed efficient body washing, solubilization, and protein refolding strategies for recombinant therapeutics.
• Designed purification workflows for recombinant protein production with enhanced recovery and purity outcomes.
• Contributed to process optimization initiatives supporting therapeutic protein development programs.

Ph.D. - Biotechnology - Research - Savitribai Phule Pune University, India (2011-02 - 2016-03)

M.Sc. - Biotechnology - University of Hyderabad, India (2006-01 - 2008-01)