Marcin A. Dworak

Charles River Laboratories – Associate Director, Biomanufacturing
Memphis, TN | Sep 2024 – Present

• Lead manufacturing operations for clinical and commercial Cell Therapy Drug Substance and Drug Product (Vial and Bag Fill).
• Member of Site Leadership Team (SLT) overseeing strategic planning, capacity utilization, and compliance.
• Drive cross-functional collaboration across Manufacturing, QC, and Process Sciences to align operations with client and regulatory expectations.
• Championed continuous improvement initiatives: Reduced deviations by 30%, increased closure rates by 40%, and introduced Tier 1–2 Management Structures.
• Hosted FDA and EMA inspections with strong compliance outcomes.
• Advanced site visual inspection and quality culture, embedding a “Safety First, Quality Always” mindset.

Takeda Pharmaceuticals – Associate Director, Cell Therapy Quality Assurance
Cambridge, MA | May 2022 – Sep 2024

• Directed QA operations for R&D Cell Therapy GMP manufacturing, governing batch review, deviation oversight, and IMP disposition.
• Led QA teams for facility, equipment, and materials lifecycle ensuring end-to-end compliance from vector production to aseptic filling.
• Improved disposition timelines by 80%, achieving faster lot release while maintaining audit readiness.
• Implemented PAS-X, SAP, and electronic logbooks, improving data integrity and reducing manual errors by 30%.
• Oversaw global inspection readiness and led site through successful regulatory inspection with zero major findings.
• Enhanced interdepartmental collaboration to instill “Quality on the Floor” and proactive risk-based oversight.

• Managed QA Client Alliances for biologics and cell therapy projects, ensuring compliance with global cGMP and contractual commitments.
• Served as Quality liaison for Fill-Finish programs; streamlined review and approval processes reducing backlog by 35%.
• Headed Technical Operations for manufacturing, integrating continuous improvement initiatives and KPI-driven management systems.
• Launched investigation closure program – tripled deviation closure rates and reduced open records by 30%.
• Partnered with global leadership on product/process improvement initiatives and tech transfers across multiple sites.

• Under general supervision, provided support and compliance oversight to MFG and F&E, QC, QM, and MM staff in the execution of their processes procedures and use of quality systems EBR record review closure, SOP review and approval in EDMQ Review.
• Supported Functional areas during inspection audits.
• Ensured raw materials and components, bulk drug substances, bulk drug products, and finished product for assigned areas meet GMP requirements.
• Ensured the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records, including non-conformances, CAPAs, change control records and validations. (Quality records management).
• Performed AQL for Visual Inspection (Final Drug Product).
• Provided Training and Qualification for Drug Product Visual Inspection.
• Released gases, cell banks and Drug Product labels.
• Oversaw the Aseptic Processing filling and provided advice and guidance during the process.
• Aseptic processing (i.e. Environmental qualification, Media fills).

• QC sampling and testing following Standard Operating Procedures (SOPs) and established test methods within the function of the GMP/cGMP Quality Control (QC) Laboratory.
• Performed QC testing of in-process, final product, and raw material samples according to Standard Operating Procedures.
• Test methods included TOC Method Qualification, Raw Materials Inspection and Release. TOC, Heavy Metals, Nitrate, Conductivity, AQL, pH, Endotoxin and Osmolality Testing. FPLC, Plaque, Tissue Culture, Western Blot. Elisa(s). Drug Product shipment and handling.
• Tracked and trended generated QC data.
• Revised QC SOP’s documentation in accordance with current GMP.
• Trained team members.
• Scheduled and organized lab testing’s/activity’s.
• Deviation, CAPA, Change Control owner and author. (Record Management).
• Method Transfer.
• Sampling Plans.
• Implemented appropriate corrective actions within quality systems.
• Managed GAP Assessments/Equipment installation.
• Subject matter Expert: TOC, Endotoxin, Conductivity, Heavy Metal, Nitrates, Raw Materials, Western Blotting and Visual Inspection for Drug Product (AQL).
• Performed QC review and approval of documents.
• Managed/scheduled and organized sample shipments for contract laboratories.
• Managed Drug Product (DP) Stability inventory and ensured DP testing was complete.
• Managed weekly activities for QC department, ensuring completion.
• Quarterly metrics.
• Method Transfer.
• Coordinated and managed QC equipment.
• Purchased the equipment.
• Assigned PM and calibration requirements and owner of the equipment.
• Ordered reagents and ensured safety within the QC laboratory.
• Created Safety Documentations for Vendors (JAH and PWP); Managed the Vendors and project for QC equipment Reviewing and generating IQOQ validation reports.
• Author of URS for the QC Equipment.

• Responsible for all aspects of preparing and running agarose and polyacrylamide electrophoresis gels, data entry, image analysis, Perform 1D, 2D electrophoresis, Western Blot and PAG.
• Prepare polyacrylamide gels, perform immunoblotting, scan membranes and load images.

• Verified surgical specimen identification with surgical pathology request form.
• Maintained and assured correct identification of the specimen through the grossing and sampling processes, following numerical accessioning.
• Assured assembly of the necessary administrative components of the postmortem examination, including Authorization for Autopsy, Autopsy Information Form and chart, and Certificate of Death and maintaining attention to detail during actual autopsy.
• Obtained all necessary specimens for special studies such as body fluids and tissue, delivered to appropriate clinical laboratories.
• Effectively managed rush test orders, communicating with key medical personnel, ensuring accurate patient data was entered, and that proper stains were ordered.
• Performed all specified lab tests according to standard operating procedures (SOP) to maintain a safe environment free from contamination or exposure to diseases.
• Assisted promptly with resolution of specimen identification problems, especially with critical situations such as liver or kidney transplants and ectopic pregnancies.
• Collection of tissue for cytogenetic, tumor bank/storage different tissue types.
• Experience working under the hood and full gowning experience.
• Internship with UMass Pathology Frozen Section, EM Lab, Cytology and Molecular.

• Provided technical support to lab by receiving and processing requisitions/specimens and assigning specified lab tests/orders.