MARCIN DWORAK

Lead Manufacturing Operations supporting commercial and clinical cell therapy production while partnering with executive leadership to deliver compliant, efficient manufacturing operations across drug substance and drug product manufacturing.

Selected Accomplishments

• Reduced manufacturing deviations by 30% through strengthened operational controls, coaching, and quality oversight.
• Increased deviation closure performance by 40%, improving inspection readiness and reducing quality system backlog.
• Successfully led manufacturing operations during FDA and EMA regulatory inspections.
• Implemented Tier Management, improving operational communication, escalation, and accountability.
• Built a “Safety First, Quality Always” culture that strengthened GMP compliance across manufacturing.
• Enhanced Visual Inspection strategy supporting commercial manufacturing.
• Partner with Site Leadership to establish manufacturing strategy, capacity planning, operational readiness, and commercialization initiatives

Provided strategic Quality Operations leadership for Takeda’s Cell Therapy Manufacturing Facility, overseeing GMP manufacturing, quality systems, and batch disposition supporting investigational and late-stage cell therapy programs. Partnered with Manufacturing, MSAT, Engineering, Facilities, QC, Supply Chain, Validation, and Regulatory Affairs to strengthen compliance, accelerate product delivery, and maintain a state of continuous inspection readiness.

Selected Leadership Contributions

• Directed Quality Operations supporting GMP manufacturing, aseptic processing, and cell therapy commercialization activities.
• Led Quality oversight for manufacturing operations, ensuring compliance with cGMP, global regulatory expectations, and internal quality standards.
• Built and developed high-performing QA teams through coaching, mentoring, and quality culture initiatives.
• Directed compliant batch record review and disposition of investigational cell therapy products while ensuring timely release decisions.
• Led complex deviation investigations, CAPA strategy, risk assessments, and change control activities to improve product quality and operational performance.
• Partnered with Manufacturing leadership to strengthen operational excellence and improve collaboration between Quality and Operations.
• Oversaw facility, equipment, utilities, and critical materials quality throughout the product lifecycle.
• Successfully supported global regulatory inspections while maintaining continuous FDA and EMA inspection readiness.
• Strengthened aseptic processing controls and alignment with EU GMP Annex 1 expectations.
• Improved Quality Management System effectiveness through implementation of electronic systems, standardized processes, and continuous improvement initiatives.
• Served as Quality representative for technology transfers, manufacturing readiness, and new product introductions.

Key Accomplishments

• Improved batch disposition timelines by approximately 80%, accelerating clinical product availability.
• Implemented PAS-X and supported SAP integration to improve electronic batch documentation and operational efficiency.
• Enhanced data integrity and compliance across Quality Control laboratories.
• Established Drug Product Visual Inspection processes for cell therapy manufacturing.
• Strengthened Annex 1 compliance for aseptic processing operations.
• Eliminated unnecessary QA approval workflows, improving operational efficiency.
• Reduced paper-based documentation through implementation of electronic quality systems.
• Successfully supported global regulatory inspections with no significant quality observations.

Promoted through multiple leadership positions of increasing responsibility across Quality Operations, Manufacturing, Compliance, Client Alliance, and Fill-Finish Operations. Led cross-functional teams supporting sterile manufacturing, client programs, quality systems, and operational excellence initiatives within a commercial CDMO environment.

Leadership Responsibilities

• Directed multidisciplinary teams supporting manufacturing operations, quality systems, engineering, validation, and client programs.
• Partnered with executive leadership and clients to deliver compliant manufacturing operations while improving operational performance.
• Led strategic initiatives focused on deviation reduction, CAPA effectiveness, inspection readiness, and continuous improvement.
• Served as Quality representative for commercial fill-finish operations, technology transfers, and client governance.
• Oversaw change controls, investigations, risk assessments, and implementation of corrective and preventive actions.
• Developed performance metrics, dashboards, and Tier Management systems to improve operational visibility and accountability.
• Drove cross-functional collaboration between Manufacturing, QA, QC, Engineering, MSAT, Validation, and Supply Chain.
• Provided executive updates to senior leadership regarding manufacturing performance, quality metrics, and operational risks.

Key Business Achievements

• Reduced manufacturing deviations by approximately 30% through implementation of standardized operational controls and proactive quality oversight.
• Increased deviation closure performance from approximately 10 to 30 investigations per month, significantly reducing backlog.
• Implemented Tier Management systems that strengthened communication, escalation, and accountability across manufacturing operations.
• Designed and implemented Visual Inspection bracket strategies supporting sterile fill-finish manufacturing.
• Implemented product-specific visual inspection qualification programs aligned with USP .
• Improved quality oversight for Optima fill-finish isolator operations supporting commercial sterile manufacturing.
• Served as primary Quality liaison for key client programs, strengthening customer relationships and delivery performance.
• Led implementation of operational dashboards and KPI reporting to improve decision-making and manufacturing execution.
• Built a “Safety First, Quality Always” culture that strengthened GMP compliance and employee engagement.
• Successfully supported internal, client, and regulatory inspections while maintaining inspection readiness.

Progressed from Quality Control into Quality Assurance, developing extensive expertise across commercial biologics manufacturing, aseptic processing, sterile fill-finish, and Quality Operations. Served as a strategic Quality partner supporting Manufacturing, Facilities & Engineering, Quality Control, Materials Management, and Supply Chain while ensuring compliance with FDA, EMA, and global cGMP requirements.

Recognized as a subject matter expert in Visual Inspection (USP ), aseptic manufacturing, and commercial biologics, providing technical leadership that strengthened inspection readiness, product quality, and manufacturing performance.

Selected Leadership Contributions

• Provided Quality oversight for commercial biologics manufacturing, sterile fill-finish operations, and aseptic processing from raw material receipt through final drug product release.
• Served as the Quality lead supporting Manufacturing during critical aseptic operations, environmental qualification activities, contamination control initiatives, and media fill execution.
• Directed batch record review, product disposition, deviation investigations, CAPAs, change controls, risk assessments, and Quality System documentation to maintain GMP compliance.
• Functioned as the site Subject Matter Expert (SME) for Visual Inspection (USP ), leading operator qualification, AQL inspection programs, defect classification, and visual inspection process improvements.
• Developed and qualified manufacturing personnel on manual visual inspection techniques, strengthening inspection consistency and regulatory compliance.
• Partnered with Manufacturing, Engineering, Validation, and Quality Control to improve operational execution, resolve complex manufacturing issues, and maintain continuous inspection readiness.
• Supported regulatory inspections and internal audits by providing technical expertise across sterile manufacturing, aseptic processing, and Quality Systems.

Key Accomplishments

• Established and strengthened Visual Inspection programs aligned with USP , improving operator qualification and inspection reliability.
• Provided Quality leadership supporting aseptic processing, sterile filling operations, media fills, environmental qualification, and contamination control strategies.
• Managed Quality oversight for commercial biologic drug products while ensuring timely batch disposition and regulatory compliance.
• Served as a trusted Quality advisor for investigations, root cause analysis, and implementation of sustainable CAPAs.
• Led QC initiatives involving raw material release, analytical testing, equipment qualification, method transfers, stability programs, and laboratory process improvements.
• Built a strong technical foundation in Quality Operations, sterile manufacturing, and biologics that supported progression into senior leadership roles across the biotechnology industry.

EARLY CAREER

Developed foundational biotechnology laboratory experience supporting clinical diagnostics, protein analysis, electrophoresis, immunoblotting, and analytical testing within a regulated laboratory environment. Gained expertise in laboratory operations, data integrity, quality documentation, and standardized laboratory procedures that established a strong technical foundation for a career in biotechnology and GMP manufacturing.

Built a strong scientific and operational foundation supporting pathology, clinical laboratory operations, specimen management, molecular diagnostics, and patient-focused laboratory services. Developed expertise in specimen traceability, documentation accuracy, laboratory quality practices, biosafety, and cross-functional collaboration while working in a highly regulated healthcare environment. This experience established the attention to detail, quality mindset, and scientific discipline that supported progression into commercial biotechnology manufacturing and Quality Operations leadership.