Experienced Leaders. Proven Results
Vadim Klyushnichenko, Ph.D.
Founder and Principal Consultant
Fractional VP CMC • Quality • Regulatory • Technical Operations
Executive CMC leader with 30+ years of experience guiding biotechnology and pharmaceutical programs from discovery through commercialization. Former leadership positions at Pfizer, Sanofi, Baxter, Piramal (CSL), Catalent (Paragon BioServices), Terapio Corp., and The Scripps Research Institute. Expertise includes CMC strategy, Quality Systems, global CDMO oversight, regulatory submissions, and AI-enabled pharmaceutical development.
Expertise
- CMC Strategy
- Regulatory Affairs
- Quality Systems
- CDMO Oversight
- GMP Audits
- AI in CMC
Advisory Team
Mark Fitchmun, Founder and CEO, Somatek
Mark Fitchmun is the Founder and CEO of Somatek, a biopharmaceutical development company specializing in early-stage process development, analytical development, and CMC support for biologics. His team assists biotechnology companies in establishing robust manufacturing processes, developing and optimizing analytical methods, and preparing technologies for successful transfer to GMP manufacturing.
With more than 25 years of industry experience, Mark has led development programs involving monoclonal antibodies, ADCs, recombinant proteins, viral vectors, enzymes, diagnostics, and other complex biologics. His expertise includes upstream and downstream process development, analytical method development and qualification, formulation support, technology transfer, and early CMC development.
At Key Pharma, Mark provides technical expertise in biologics process development, analytical development, manufacturing technologies, and early-stage CMC development.
Serguei Tchessalov, Ph.D.
Serguei Tchessalov, Ph.D. is the Founder of SN Lyophilization, a consulting firm specializing in freeze-drying, formulation development, and sterile drug product manufacturing. He earned his Ph.D. from the Institute of Applied Biochemistry and completed postdoctoral training under Prof. Michael J. Pikal at the University of Connecticut.
With more than 40 years of experience, Dr. Tchessalov has held scientific leadership positions at Immunex, Wyeth, and Pfizer, supporting the development of vaccines, biologics, proteins, mRNA therapeutics, and other sterile pharmaceutical products. He is an internationally recognized expert in lyophilization process development, scale-up, technology transfer, and aseptic manufacturing, and has authored more than 30 peer-reviewed publications in the field.
At Key Pharma, Dr. Tchessalov provides strategic expertise in formulation development, lyophilization, technology transfer, and commercial manufacturing of sterile drug products.
Ramgopal (Ram) Nadimpalli, Ph.D., M.B.A.
With about 18 years of experience, Ram is a seasoned professional in drug development program management, demonstrating extensive expertise in research and development as well as program and alliance management across multiple therapeutic areas. His areas of specialty include oncology, immuno-oncology, infectious diseases, respiratory, autoimmune, and inflammatory disorders. Ram’s technical and program management expertise covers different drug modalities, including monoclonal antibodies, recombinant proteins, vaccines, and advanced cell therapies. Ram earned a Ph.D. in Pharmacy from the University of Georgia, and an MBA from the University of Maryland. He holds certifications as a Project Management Professional (PMP) and a Six Sigma Black Belt. Throughout his career, he has held pivotal roles in research, product development, and program management at leading pharmaceutical and biotech firms, including Dupont Pioneer, Roche, Gene Logic, AstraZeneca, TSRI, and Mnemo Therapeutics.
Irene Klyushnichenko, M.B.A.
Irene Klyushnichenko, MBA is a financial planning and analysis (FP&A) professional with more than 20 years of experience in financial analysis, budgeting, forecasting, and business process improvement across multiple industries. She specializes in helping biotechnology companies build financial models, optimize resource allocation, and provide the financial insights needed to support product development and business growth.
Irene holds an MBA in Finance from Boston University and a B.A. in Economics from the University of Massachusetts Boston. Her expertise includes financial modeling, budgeting and forecasting, KPI development and reporting, pricing strategy, market analysis, accounting support, and cross-functional project management.
At Key Pharma, Irene provides strategic financial planning and business analysis to support R&D organizations, clinical development programs, and emerging biotechnology companies.
Val Bunchak, M.S.
Val Bunchak is a mechanical engineer with more than 30 years of experience in engineering, facilities management, warehouse operations, and logistics. He specializes in supporting biotechnology and pharmaceutical organizations through equipment installation, maintenance, calibration, qualification, and operational readiness.
His expertise includes laboratory and manufacturing equipment maintenance, equipment qualification (IQ/OQ), calibration programs, preventive maintenance, facility support, warehouse operations, and logistics coordination.
At Key Pharma, Val provides engineering and operational expertise to support laboratory and manufacturing facilities, equipment qualification, maintenance programs, and technical infrastructure.
Extended Team of Experts
Our extended team consists of the network of experts with advances degrees and 15-25 years of hands-on experience in bio/pharaceutical industry. Our experts can help you in the following areas:
- Development of mAb, Fab, Recombinant Proteins, and Enzymes for therapeutic use
- Development of conjugated proteins for early and late stage
- PEGylation
- ADC
- Bispecifics
- Cell and gene therapy
- Process Development, MSAT, Validation, Quality, and Manufacturing
- External Manufacturing, Risk Management, Downstream Development, and Process Characterization
- Project, Program, and Portfolio Management
- Supply chain/cold chain
- Quality Management Systems
- GMP/Quality Audits and Due Diligence
Industry experience
