Dipak Dhumal
Deputy General Manager
Hyderabad
Summary
Accomplished professional with a Master of Technology in Bioprocess Technology from the Institute of Chemical Technology, Mumbai, and nearly 20 years of experience in the biopharmaceutical industry. Currently leading downstream purification and technology transfer teams at Curateq Biologics, a subsidiary of Aurobindo Pharma Ltd. Previous contributions include R&D and MSAT roles at prominent biotech organizations such as Syngene International, Wockhardt Limited, and Biocon Limited. Expertise includes early and late-phase downstream purification process development, scale-up, and technology transfer across various therapeutic modalities, including monoclonal antibodies and recombinant proteins. Certified Statistician and Data Scientist, skilled in leveraging Quality by Design (QbD) principles and advanced data analytics to drive process optimization and ensure regulatory compliance in product commercialization.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Deputy General Manager
Curateq Biologics (https://curateqbio.com/)
03.2024 - Current
- Leading a downstream R&D and technology transfer team of 20+ scientists and engineers for the commercialization of multiple biosimilars (monoclonal antibodies, fusion proteins, microbial proteins, conjugated proteins, etc.).
- Late-stage process development, scale-up, and commercialization of pipeline mAbs and therapeutic protein biosimilars (Denosumab, Omalizumab, Tocilizumab, Trastuzumab, Peg-GCSF, etc.).
- Early-stage process development and scale-up of pipeline mAbs and therapeutic protein biosimilars (Pertuzumab, Ocrelizumab, Secukinumab, Dupilumab, Romiplostim, etc.).
- Development of high-concentration formulations (novel and biosimilar) of trastuzumab, tocilizumab, etc.
- Designing and delivering late-phase studies, such as scale-down modeling, process characterization, resin, and membrane lifetime, etc. Enabling successful regulatory submissions.
- Conducted virus clearance studies at BioReliance and Sartorius for three programs for regulated market regulatory submission.
- Prepared and reviewed downstream documents for early and late-stage development, tech transfer, and regulatory submissions for ensuring compliance and global filing readiness.
- Driving process development and technology transfer through Quality by Design (QbD) and Design of Experiments (DoE) approaches to establish robust process control strategies, and ensure global regulatory compliance.
- Https://curateqbio.com/
- Led the resolution of EMA regulatory queries for filed products (Trastuzumab, GCSF, and Peg-GCSF), enabling their successful approval and market entry in the EU.
- Engaging with strategic partners for in-licensing of new biologic products (ustekinumab, aflibercept, etc.). And ensuring smooth knowledge transfer and integration into the pipeline.
- Collaborating with upstream, formulation, and analytical development groups to ensure end-to-end integration of biologics process development.
- Providing strategic leadership by aligning R&D, MSAT, and manufacturing teams to minimize tech transfer risks.
- Building, mentoring, and leading multidisciplinary teams across early and late-stage process development R&D, and MSAT functions, fostering a culture of innovation, accountability, and compliance.
- Leading tech transfer programs from R&D to commercial-scale GMP facilities, supporting engineering batches, and PPQ campaigns for ensuring seamless transition, process robustness, and regulatory readiness.
- Partnering with CMC regulatory teams to generate high-quality data packages, supporting dossier preparation, and addressing global regulatory agency queries (EMA, USFDA, and others).
- Serving as a senior leadership representative in management forums, providing strategic direction for product development and commercialization.
Senior Research Scientist/Group Lead
Syngene International Limited (CDMO) (https://syngeneintl.com/)
08.2020 - 03.2024
- Lead a group of scientists and engineers involved in the downstream purification process development, process characterization, and technology transfer projects of mAbs (monoclonal antibodies), microbial proteins, pDNA, bioconjugates, etc. Of leading global biopharmaceutical clients.
- Process and unit operation-level risk assessment (through FMEA), scale-down model qualification (SDM), and process characterization (PC) studies of downstream purification process unit operations and drug product processes.
- Design and deliver other late-phase studies, like resin lifetime studies, impurity/media spiking studies, freeze-thaw studies, hold time studies, worst-case studies, etc.
- Pilot-scale batches for drug substance (DS) material generation for toxicity studies, process consistency demonstration, and technology transfer to 500L and/or 2KL scale.
- Review of technical reports (process protocol, technical report, development report, TTD, process control strategy, manufacturing batch record, validation master plan, PPQ protocols, etc.). For a regulated market application.
- Served as a Downstream SME (Subject Matter Expert) for a key client, Zoetis, by leading process development and technology transfer activities for at least three monoclonal antibodies.
- Supported US FDA and EMA submissions and approvals (including PAI and facility change audits), culminating in the successful commercial launch of ‘Librela’ (Bedinvetmab) - Syngene’s first US FDA-approved client product to reach markets.
- Served as ‘Technical Lead’ for end-to-end project delivery by overseeing the full product lifecycle from clone development to manufacturing, managed business objectives via the ‘Scope of Work (SoW),’ and ensured on-time delivery of all project milestones.
- Lead the initial project feasibility assessment based on the 'Request for Proposal (RFP)' by driving client and matrixed CFT discussions.
- Evaluation of new technologies, like membrane chromatography (Fibro PrismaA) and Raman spectroscopy-based PAT (Merck-ProCellics), for aggregates and concentration estimation in a chromatography step.
- Leadership role in setting up and driving the data analytics strategy for all aspects of the process development to enable robust, efficient, and statistically sound development and characterization of processes based on QbD principles.
- Presented regularly to clients for a summary of process development status, exhaustive statistical data analysis for SDM and PC studies, executed batch trending, etc.
- Developed and optimized protein–polymer conjugation processes (non-cytotoxic) for Phase 1 clinical supply.
- Contributed to authoring the FDA CMC Module 3 – Drug Substance sections, and prepared scientific justifications for regulatory query responses.
Senior Group Leader/Assistant General Manager (R&D and MSAT)
Wockhardt Biologics (https://www.wockhardt.com/)
09.2018 - 08.2020
- Lead a small team for downstream process development, technology transfer, and life cycle management of recombinant human insulin and analogues, as well as GLP-1 analogues produced through E. Coli platform.
- Performed activities related to downstream process technology transfer from lab scale to commercial manufacturing (15 KL and 2 KL fermentation scale), risk assessment through FMEA, evaluation of facility and equipment designs, equipment comparability and capabilities assessments, scale-up gap analysis, process calculations, and design of scale-up optimization studies, etc.
- Designed and qualified scale-down models of downstream unit operations at lab scale to enable process characterization and validation.
- Served as a subject matter expert for process failure investigations and troubleshooting at the pilot and commercial scale.
- Lead continuous improvement: Implemented statistical quality control and Six Sigma methodologies through detailed statistical analysis, trending of manufacturing scale data through platforms like Sartorius-SIMCA, JMP, Minitab, etc.
- Applied machine learning (R programming), multivariate data analysis, and predictive modeling (Multiple Linear Regression, PCA, OPLS, Decision Tree, etc.). For manufacturing-related problem-solving and the implementation of long-term solutions that improve processes and products.
- Involved in process performance analytics, root cause investigation, corrective and preventive action, support for the annual product quality review, etc.
- Led end-to-end downstream process development of the GLP-1 analogue (Liraglutide) produced using an E. Coli expression platform, from lab-scale optimization to scale-up readiness.
Associate Scientific Manager 1 & 2
Biocon India Limited, R&D (https://www.biocon.com)
08.2014 - 08.2018
- Downstream purification process development and process characterization of peptides, proteins, and other biomolecules at the lab and pilot scale by the QbD approach for regulated and domestic market applications.
- Handled process development, cost improvement, scale-up, and technology transfer of R&D processes to 10KL to 100KL scale for at least six products.
- Experienced with various chromatography techniques, such as ion exchange, hydrophobic interaction, reverse phase, normal phase, etc.
- Analytical method development, qualification, and transfer of techniques like HPLC, UPLC, GC, and other in-process analytical techniques.
- Well-acquainted with peptide/protein characterization techniques like HPLC-MS, NMR, CD, cIEF, SEC-MALS, C/N-terminal analysis, peptide mapping, etc.
- Process optimization through DOE techniques like full factorial, fractional factorial, Taguchi, response surface methodology, definitive screening design, custom DoE, etc.
- Involved in setting up a new lab, equipment ordering, installation, and qualification (IQ, OQ, and PQ).
- Resource allocation, planning, process costing, and CAPEX budgeting of assigned projects.
- Coordination with senior management, CMC team members, and technology transfer to other locations.
- Supported process validation activities through the review of Batch Manufacturing Records, PPQ Protocols/Reports, etc.
- Coordination with cross-functional teams involving manufacturing, QA, QC, regulatory, etc. For technology transfer and smooth process change implementation.
Principle Scientist, Scientist
Biocon India Limited, R&D (https://www.biocon.com)
07.2007 - 07.2014
- Downstream process development and optimization of peptides, and other biomolecules at lab, pilot scale, and scale-up, technology transfer to manufacturing scale.
- Execution of experiments related to chromatography process development – column packing, resin screening, static and dynamic binding capacities, process parameters optimization, resin lifetime studies, etc.
- Execution of experiments related to process development of other downstream unit operations, like tangential flow filtration, depth filtration, crystallization, lyophilization, cytotoxic bioconjugations, and centrifugation, etc.
- Experienced in enzymatic reactions like protease-mediated hydrolysis, esterification, endonuclease-catalyzed DNA degradation, etc.
- Formulation process development and batch execution for aseptic vial filling in a classified area.
- Preparation of TTD, technical reports, process protocols, development reports, URS, COAs, SOPs, etc.
Post Graduate Researcher
Institute of Chemical Technology (http://www.ictmumbai.edu.in/)
07.2006 - 06.2007
- Production of a cellulolytic enzyme, β-glucosidase, from a fungal and bacterial source.
- Downstream purification of β-glucosidase by centrifugation, ammonium sulfate precipitation, dialysis, ion exchange chromatography, and size exclusion chromatography.
- Biotransformation reactions for the synthesis of novel glucosides.
Quality Assurance Officer
QA Technical Services (I) Private Limited (http://www.cipla.com/en/)
01.2005 - 07.2005
- Audited 35+ APIs, RMs, and packaging material suppliers as a lead auditor for vendor qualification and approval.
- Handled complaints and queries raised by end users at any CIPLA unit about APIs, RMs, and packaging materials.
- Worked diligently with vendors, and provided recommendations for GMP compliance.
- Authored SOPs, prepared an approved supplier list, manufacturing checklist, etc.
- Vendor audit summary report preparation.
- Trained in cGMP, internal, and external auditing.
Education
Post Graduate Diploma - Operations Management
Narsee Monjee Institute of Management Studies
Mumbai, India06-2023
Statistical Quality Control and Six Sigma Green Belt - Statistical Quality Control & Six Sigma
Indian Statistical Institute
Bengaluru, India10-2016
Post Graduate Diploma - Patent Law
NALSAR Law University
Hyderabad, India06-2012
M. Tech - Bioprocess Technology
Institute of Chemical Technology (formerly UDCT/UICT)
Mumbai, India06-2007
B. Pharm - Pharmaceutical Sciences
University of Pune
Pune, India06-2004
Skills
Technical: Early and Late Phase Process Development, Scale Down Modelling, Process Characterization, Resin Lifetime Studies, Scale-up and Technology Transfer, Product Life Cycle Management, Protein Conjugations, High Concentration Formulations, Shake Flask Fermentation, Biotransformation etc
Statistical: Design of Experiments (DoE), Multivariate Data Analysis, Predictive Modelling, Process Analytical Tools, Statistical Process Control, Comparability Studies, Six Sigma Implementation, Data Visualization and Trending, Machine Learning etc
Leadership: Program and Portfolio Management, Decision Making, Talent Development, Cross-functional Relationship, People Management, Empowerment and Delegation etc
Software: JMP, Minitab, Sartorius-SIMCA, Python and R Programming, Microsoft Office, EDMS, Trackwise, SAP etc
Other: Process Costing, Regulatory Filing & Support, Intellectual Property Rights etc
Human Languages: English (Professional), Marathi (Native), Hindi (Fluent) and Kannada (Beginner)
Certification
Machine Learning and Data Science March 2018-August 2018 Learnbay Training Institutes, Bengaluru, India. https://www.learnbay.co/
Timeline
Deputy General Manager
Curateq Biologics (https://curateqbio.com/)
03.2024 - Current
Senior Research Scientist/Group Lead
Syngene International Limited (CDMO) (https://syngeneintl.com/)
08.2020 - 03.2024
Senior Group Leader/Assistant General Manager (R&D and MSAT)
Wockhardt Biologics (https://www.wockhardt.com/)
09.2018 - 08.2020
Associate Scientific Manager 1 & 2
Biocon India Limited, R&D (https://www.biocon.com)
08.2014 - 08.2018
Principle Scientist, Scientist
Biocon India Limited, R&D (https://www.biocon.com)
07.2007 - 07.2014
Post Graduate Researcher
Institute of Chemical Technology (http://www.ictmumbai.edu.in/)
07.2006 - 06.2007
Quality Assurance Officer
QA Technical Services (I) Private Limited (http://www.cipla.com/en/)
01.2005 - 07.2005
Post Graduate Diploma - Patent Law
NALSAR Law University
B. Pharm - Pharmaceutical Sciences
University of Pune
Post Graduate Diploma - Operations Management
Narsee Monjee Institute of Management Studies
Statistical Quality Control and Six Sigma Green Belt - Statistical Quality Control & Six Sigma
Indian Statistical Institute
M. Tech - Bioprocess Technology
Institute of Chemical Technology (formerly UDCT/UICT)