Highlights:I introduce myself as Dipak Dhumal, a biopharmaceutical professional with specialization as Process Scientist and Certified Statistician/Data Scientist. I possess 15+ years of strong RnD + MSAT experience in the area of Microbial and Mammalian downstream purification process development, process characterization, technology transfer, product lifecycle management etc. of Monoclonal antibodies (mAb’s), Recombinant Proteins, Insulins, Peptides, Protein Conjugations etc.

Skills:Downstream Purification, Early and Late Phase Process Development, Scale-up, Technology Transfer, Statistics, MSAT

Goal:Looking for opportunity in Downstream purification. My area of expertise involves Technology transfer (MS&T), early and late phase process development / characterization studies, statistical process control etc.

Certification:1) M. Tech. (Bioprocess Technology) from Institute of Chemical Technology (formerly UDCT/UICT), Mumbai. http://www.ictmumbai.edu.in/ 2) One Year Course in Statistical Quality Control and Six Sigma Green Belt from Indian Statistical Institute (ISI) Bangalore http://www.isibang.ac.in/ 3) MBA (Operations Management) from NMIMS University, Mumbai, India https://www.nmims.edu/ 4) PGDPL (Patent Law) from NALSAR Law University, Hyderabad https://www.nalsar.ac.in/.

Senior Research Scientist 08/2020 - current
Syngene International (Biologics), Bangalore, Karnataka India
Industry: Biopharmaceutical
Process Development & Characterization, Statistics, Leadership, Client relationship etc.
• Leading a group of scientists and engineers involved in drug substance and drug product process development, process characterization, technology transfer and validation projects (Monoclonal antibodies, Microbial Proteins, Protein-polymer conjugates, pDNA, mRNA etc.) of leading global biopharmaceutical clients. • Leadership role in setting up and drive the statistical strategy for all aspects of process and product development to enable efficient, robust, and statistically sound development and characterization of processes based on QbD principles. • Downstream SME for USFDA PAI and PPQ campaign for commercialization of client’s mAb process. • Risk assessment, scale-down model qualification and process characterization studies of downstream purification unit operations and drug product process. • Design and deliver other late phase process development studies like Resin lifecycle studies, Virus clearance studies, Media spiking studies, Freeze thaw studies, Hold time studies etc. • Review of technical reports (Process protocols, Technical reports, Development reports, TTD’s, Control Strategy, Batch Manufacturing Reports, Validation Master Plan, PPQ protocols etc.) for a regulated market application. • Exhaustive statistical data analysis, interpretation of results and presentation.--
Senior Group Leader 09/2018 - 08/2020
Wockhardt Biologics, Aurangabad, Maharashtra India
Industry: Biopharmaceutical
MSAT, Process Development and Characterization, Statistics, Leadership etc.
• Lead a small team of MSAT scientists and engineers involved in the downstream purification process technology transfer of recombinant proteins. • Performed all activities associated with technology transfer of new process for recombinant GLP-1 analogues, Human Insulin and its analogues from pilot plant scale to the commercial manufacturing scale (15, 20KL and 2KL fermentation scale) of Wockhardt Site e.g. Risk analysis by FMEA, evaluation of facility and equipment design, equipment comparability and capabilities assessments, scale-up gap analysis, process calculations and design of scale-up optimization studies etc. • Review of process details and raw data from Research & Development (RnD) labs to enable process robustness at the design and implementation stage using DOE. • Coordination with senior management, CMC team on scale-up and technology transfer of assigned projects. • Leading continuous improvement (CI), implementation of Statistical Quality Control and Six-sigma through detailed statistical analysis, trending of manufacturing scale data through platforms like Sartorius-SIMCA, JMP and Minitab etc. • Application of machine learning (R and Python programming), multivariate data analysis and predictive modelling (Multiple Linear Regression, PCA, PLS, OPLS etc.) for manufacturing related problem solving and implementation of long-term solutions that improves process and product. • Providing technical leadership and SME for process failure investigation and troubleshooting at pilot and manufacturing scale. • Ensuring process performance analytics, root cause investigation, support for APQR etc. • Scale-up, scale-down modelling and qualification of downstream unit operations at pilot scale. • Preparation and review technical reports for a regulated market application. • Implementation of QbD and PAT framework across all drug substances lifecycles at Wockhardt.--
Associate Scientific Manager 08/2014 - 08/2018
BIOCON Limited, Bangalore, Karnataka India
Industry: Biopharmaceutical
Technology transfer, Statistics, Leadership
• Lead a team of scientists for downstream purification process development and process characterization of proteins/peptides at the lab and pilot scale by QbD approach for regulated and domestic market application. • Handled process development, cost improvement, technology transfer and validation activities for at least 5 biomolecules. • Resource allocation, Ordering, Costing, CAPEX Budgeting of assigned projects. • Process optimization through DOE techniques like Factorial, Fractional factorial, Taguchi, Response surface methodology, Definitive screening design etc. • Exhaustive data collection and statistical data analysis of Upstream and Downstream processes. • Co-ordination with senior management, CMC team members and Biocon’s partners on technology transfer to other locations. • Worked closely with manufacturing team as technical subject matter expert on technology transfers- evaluation of facility and equipment design, scale-up gap analysis, risk analysis by FMEA etc. • Support process validation activities. Preparation and/or review of Batch Manufacturing Records, Process Validation Protocols/Reports, etc. • Provide technical leadership and SME for process failure investigation and troubleshooting at pilot and manufacturing scale. • Co-ordination with cross functional teams involving Manufacturing, QA, QC, Regulatory etc. for technology transfer and smooth process change implementation. • Faced regulatory audits of regulatory agencies like USFDA, COFEPRIS etc.--
Principal Scientist 07/2007 - 07/2014
BIOCON Limited, Bangalore, Karnataka India
Industry: Biopharmaceutical
Process Development, Product Analysis, Statistics, Manufacturing Support etc.
• Downstream process development and optimization of proteins, peptides and other biomolecules at lab/pilot scale and its scale up, technology transfer to manufacturing. • Chromatography process development and optimization- resins screening, dynamic binding capacity, lifetime studies for process feasibility etc. • Highly experienced in process development and scale-up of downstream unit operations like Biotransformation’s, Centrifugation, Tangential flow filtration, Crystallization, Lyophilization etc. • Extensive understanding of analytical techniques like HPLC, UPLC, GC, MS, MS-TOF, MS-MALDI and other in-process analytical techniques. • Well acquainted with protein characterization techniques like CD, cIEF, SEC-MALS, C/N terminal analysis, peptide mapping etc. • Experienced in the enzymatic conversion reactions like proteases mediated hydrolysis, esterification etc. • Formulation process development and optimization. • Preparation of Technical Reports, Process Protocols, Technology Transfer Documents, Development Reports, COAs, SOPs etc. • Collection and analysis of manufacturing process data to ensure consistency of operations and identification opportunities for improvement. • Intellectual property assessment and experimental designing, regulatory query handling.--
Corporate QA 01/2005 - 07/2007
CIPLA Ltd., Mumbai, Maharashtra India
Industry: Pharmaceutical
Corporate QA
• Audited more than 35 API manufacturers and packaging material suppliers as a lead auditor as a part of vendor approval process. • Trained on cGMP, internal and external auditing. • Complaint handling for queries raised by end-users at any CIPLA unit about APIs, RMs and packaging materials etc. • Worked diligently with API supplier’s and provided recommendations for GMP compliance. • Authoring and reviewing of SOPs, preparation of approved supplier list, manufacturing checklists etc. • Vendor audit summary report preparation.--

Institute of Chemical Technology (Formerly UDCT/UICT) 06/2005 - 06/2007
Mumbai, Maharashtra, India
Degree: Master's Degree
Major:Bioprocess Technology
Minor:Downstream Purification
Specialization in Downstream Purification

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