“Think and Calibrate.”
Adam Albert Paszek, Ph.D., is a biopharmaceutical operations leader whose hallmark is turning complex science into manufacturable, compliant, and scalable therapies. Over three decades, he has guided organizations from benchtop concepts to validated GMP facilities and approved products, leading end-to-end CMC programs across biologics, cell and gene therapy, peptides, and vaccines. His career is defined by an uncommon blend of hands-on technical depth, cross-functional leadership, and disciplined execution—qualities that have helped teams deliver life-changing medicines while meeting the highest global regulatory standards.
Albert’s vantage point is broad because his path has spanned the full arc of the product lifecycle. Trained as a quantitative geneticist at the University of Minnesota, he began his career immersed in data, algorithms, and laboratory buildouts—foundation stones that later shaped his approach to GMP manufacturing and quality. As a post-doctoral researcher and then an assistant professor, he established laboratories, built teams, secured industry funding, and taught advanced analytics. Those early years refined a habit of coupling scientific rigor with practical outcomes, a habit that would become his operating ethos in industry.
In biopharma, Albert rose quickly by marrying scientific literacy with operational command. At Synageva BioPharma (later part of Alexion), he led upstream manufacturing and served as a research site head, guiding the design, construction, commissioning, and startup of two multi-product GMP manufacturing buildings and a product development facility. He created the basis of design, oversaw engineering plans, hired and trained cross-functional teams, and authored manufacturing modules for regulatory filings. The result was a robust platform for commercial-grade operations and a blueprint for how to expand capacity without compromising compliance.
That work set the stage for his leadership at Alexion Pharmaceuticals, where he directed Operations Technical Services and upstream manufacturing through process validation, tech transfer, and regulatory approvals. Albert played a central role in advancing Kanuma® to FDA, EMA, and Japan approvals, coordinating scale-up, supply chain, and quality operations while managing construction and validation budgets exceeding $35–45M. He led regulatory inspections with confidence, having engineered the systems—people, processes, utilities, documentation—that ensure readiness long before an auditor arrives.
Albert’s expertise extends far beyond monoclonal antibodies into the rapidly evolving world of cell and gene therapy. At Abeona Therapeutics, he designed and launched a state-of-the-art GMP facility, hiring and mentoring teams across Process Development, MSAT, GMP manufacturing, QC, and Supply Chain. He led the tech transfer and scale-up of the ZEVASKYN program from Stanford University, established manufacturing systems, and managed deviations and out-of-specification investigations with urgency and transparency. The work combined the exactness of engineering with the creativity required to industrialize novel modalities.
He then joined Mustang Bio to build and lead MSAT and GMP manufacturing for CAR-T therapies. There, he completed C&Q for the GMP facility, integrated Six Sigma methodologies, and directed clinical manufacturing runs for more than 25 patients in Phase 1/2 trials in non-Hodgkin lymphoma—all while sustaining full process success rates. He went deep into the technical details of MB-106, MB-101, and MB-107 programs, collaborating daily with Process and Assay Development teams. Albert’s leadership balanced the realities of patient-specific timelines with uncompromising standards for sterility assurance, documentation, and batch release.
As Vice President of GMP Manufacturing at Garuda Therapeutics, Albert was recruited to stand up operations for next-generation hematopoietic stem cell therapy. He implemented Veeva QMS, partnered with engineering on equipment layouts and facility flows, and authored the control documentation required to bridge research processes into GMP readiness. With a builder’s mindset, he connected process feasibility, scalability, and regulatory expectations, helping the organization align on a clinical-grade manufacturing path while strengthening its safety and EHS culture.
Earlier, at Cytovance Biologics, Albert returned to the production floor to optimize upstream and downstream bioprocesses, improve training systems, and streamline documentation for audit readiness. He refined workflows around 1200L single-use bioreactors and 250L stainless steel systems, reinforcing his conviction that great GMP operations arise from two inseparable ingredients: well-designed processes and well-trained people. He has repeatedly led teams of substantial size—including 70+ direct reports—while staying close to the science and the shop floor.
Most recently at Moderna, Albert served as a Senior Engineer in Quality Assurance, leading data integrity risk assessments during the launch of a new large-scale automated fill-finish drug product facility. Working across Quality, Manufacturing, Engineering, and Operations, he reviewed batch records, standardized documentation, and tightened controls across formulation, aseptic fill, and automated visual inspection. He leveraged MES, SCADA, and the DeltaV platform to ensure process consistency, and he managed change controls and CAPAs to reduce deviations and sustain GMP readiness for high-throughput commercial production.
Across companies large and small—sub-50 startups to multi-site enterprises of more than 2,000 employees—Albert has delivered under pressure. He has transferred processes across sites and organizations, executed C&Q programs on aggressive timelines, and authored and reviewed SOPs, batch records, validation protocols, and regulatory modules for INDs and BLAs. He has implemented and operated QMS platforms including TrackWise, ComplianceQuest, and Veeva; he has embedded FMEA, Kaizen, and Lean Six Sigma practices; and he has budgeted and managed manufacturing, supply chain, and facilities with a clear eye on both compliance and cost.
A hallmark of Albert’s leadership is the way he treats engineering documentation as a living language that connects design intent to daily practice. He has written and reviewed URS documents, P&IDs, and sequence-of-operations narratives, evaluated vendor components, and guided integration decisions that make equipment layouts not just elegant on paper but efficient and safe in use. He is as comfortable redlining CAD drawings as he is defending a control strategy to a regulator, translating complex technical choices into risk-based rationales that stand up to inspection.
Albert’s technical range is unusually wide: he has worked in cleanrooms with 50L, 250L, and 1200L bioreactors, managed 5,000L monoclonal antibody production, and built supply chains that can keep pace with clinical and early commercial needs. He has built MSAT and GMP organizations from the ground up, instituted training curricula with SOPs and OJTs, and reinforced a culture of continuous improvement where deviations become data and data becomes durability. Through it all, his leadership philosophy—“Think and Calibrate”—reminds teams to couple decisive action with measured learning.
Global in perspective and grounded in practice, Albert has collaborated with partners and regulators across the U.S., Europe, and Asia, including South Korea, Japan, Denmark, the U.K., Norway, France, and Australia. He brings fluency in both science and operations, with bilingual capability in English and Polish that enable cross-cultural partnership. Whether advising on CMC strategy, leading a Kaizen event on the floor, or mentoring a new manager through their first regulatory inspection, he invests in people as much as processes, believing that capability compounded over time is the ultimate competitive advantage.
Albert’s career demonstrates that precision and scale are not opposites. In his hands, they are the twin outcomes of disciplined systems thinking, clear communication, and a respect for the human craft at the heart of manufacturing. From Kanuma® approvals to CAR-T clinical manufacturing and a modern fill-finish facility launch, he has shown that great outcomes come from leaders who can inhabit the details without losing sight of the mission: delivering safe, effective therapies to patients who are waiting.
Character:
Albert leads with integrity, accountability, and steadiness under pressure. He models transparency in deviations and investigations, treating setbacks as opportunities to strengthen systems. His coaching style builds trust, creating teams that own results and celebrate shared success.
Knowledge:
He blends deep domain expertise in GMP manufacturing, validation, and regulatory pathways with hands-on mastery of equipment, automation, and documentation. His experience spans biologics, cell and gene therapy, and vaccines, enabling nuanced judgment across modalities and scales. He continually updates his toolkit—Lean Six Sigma, FMEA, MES, and QMS—so decisions are data-driven and inspection-ready.
Strategic:
Albert connects facility design, supply chain, and quality systems into cohesive CMC roadmaps. He anticipates constraints early—capacity, sterility assurance, documentation throughput—and aligns stakeholders on pragmatic plans. His strategies are measurable, cost-aware, and calibrated to regulatory expectations and clinical timelines.
Communication:
He translates complex process and engineering choices into clear risk-based rationales for executives, auditors, and operators. On the floor, he turns SOPs and batch records into teachable moments that elevate competence and consistency. In cross-functional forums, he bridges PD, MSAT, QA, QC, and Supply Chain so that objectives stay synchronized from tech transfer to lot release.
