Matt Pulaski

• Develop new GMP platforms to support product pipeline including IsoClear Assay Manufacturing and IsoClear QC Manufacturing.
• Train lab staff (R&D, MFG, CLIA Ops) on new product materials, equipment, and testing procedures.
• Write SOP's, Batch Record Templates, and associated forms in company eQMS.
• Establish QC methods and validate critical specs (shelf-life, in-process parameters, release specs, etc.) for new products and QC panels.
• Oversee the validation and implementation of new processes and equipment into manufacturing department.
• Write SOP's, Master Validation Plans, Batch Record Templates, Change Controls, and associated Forms in company eQMS.
• Assist in Deviation, CAPA, and OOS reporting utilizing root cause analysis tools (5 whys, Ishikawa Diagrams, FMEA, etc.).
• Protocol and report writing to support regulatory filings (510K, PMA, CE Mark).
• Assist QA department to ensure compliance to regulatory requirements (e.g. 21CFR820, ISO 13485, CE Marking).
• Lead lab scientist in project planning for early phase IVD test development of new oncology tests.
• Perform data analysis using Microsoft Excel, Analyse-It, and Minitab.
• Manage multi-phase pre-clinical validation studies including sample procurement, laboratory inventory, equipment maintenance, and study personnel staffing.

Supported IsoPSA PMA submission by drafting, executing, and/or reporting clinical validation studies (linearity, AMR, multi-site, interference, Guard Banding, etc.).

• Developed IsoPSA QC Panel GMP manufacturing platform and onboarded the process into eQMS. Sucessfully passed Pre-PMA Audit for the GMP Manufacturing.
• Developed process improvements for streamlining LDT testing and reducing COGS of IsoPSA at Cleveland Diagnostics.
• Managed multiple projects simultaneously, demonstrating exceptional time management skills while maintaining high levels of accuracy.
• Performed formulation development of new IsoClear Aqueous Two-Phase Systems using semi-automated liquid handling systems.
• Researched novel biomarkers and performed feasibility experiments to secure IP for expanding oncology test portfolio.
• Led training sessions on lab equipment usage for new hires, promoting a culture of continuous learning within the team.
• Troubleshot instrumentation issues, ensuring minimal downtime for critical experiments.
• Authored technical reports and manuscripts, clearly communicating complex scientific concepts to diverse audiences.

• Note: Transition from job occurred due to company being liquidated after funding ran out.
• Developed novel research formulations adhering to FDA guidelines, contributing to the advancement of insulin therapy options.
• Studied time-action profiles of next-generation Insulin products to determine efficacy of active excipients.
• Completed formulations and sterile filling of next-generation Insulin products for Preclinical Tox and Phase O studies.
• Led tech transfers for purification and formulation procedures to CMO to scale Insulin yields and support trial advancements.
• Verified analog identity and purity using ESI-Mass Spectrometry and UHPLC.
• Conducted comprehensive physical and chemical stability studies on insulin formulations, analyzing degradation patterns and aggregation characteristics.

• Maintained analytical instruments including: HPLC'S, UPLC'S, LC-MS, Lyophilizers, Biological Safety Cabinets, etc., ensuring optimal performance.
• Purified insulin analogs using advanced chromatography and filtration techniques such as: RP-HPLC, Hydrophobic Interaction Chromatography, Tangential-Flow Filtration, IEX Chromatography, .
• Executed and monitored digestion procedures of bioconjugated insulin.
• Evaluated novel reagents or technologies for potential implementation into existing workflows or assays.
• Managed inventory levels of lab consumables, ensuring continuous availability for ongoing experiments.
• Presented research findings at internal meetings, facilitating knowledge sharing among team members.

• Performed daily manufacturing and purification of rAAV Phase I clinical drugs following aseptic-techniques, ensuring high-quality output.
• Followed strict SOP and MBR protocols per FDA’s cGMP guidelines, maintaining compliance and safety.
• Managed cell culturing and harvesting on HEK cells in ISO class VII clean rooms, ensuring sterile conditions.
• Executed multiple purification techniques, including sterile filtration and chromatography, achieving optimal purity.
• Documented batch records, ensuring all forms met compliance and quality standards consistently.
• Became purification team lead responsible for overseeing efficient execution of all processes' for lot productions.

• Processed student payroll and maintained accurate timekeeping records, ensuring timely and precise payments.
• Provided exceptional administrative support for executive-level staff, ensuring that their needs were met promptly and accurately in order to facilitate smooth daily operations.
• Implemented and managed electronic filing systems, enhancing document accessibility and organization.
• Nurtured a positive work environment by addressing employee concerns promptly and fairly, fostering open communication channels between staff members at all levels of the organization.
• Supervised and trained clerical staff, improving team efficiency and onboarding processes.
• Ordered and managed supplies, ensuring uninterrupted operations and resource availability.
• Oversaw staffing distribution for daily meal production lines, optimizing workflow and boosting operational efficiency.