Matt Skrzynski Email & Phone Number

Boston, Ma, Us

Boston, Massachusetts, United States

Successfully transitioned manufacturing processes and equipment to the new commercial manufacturing facility for Lyra, a clinical-stage biotech company revolutionizing treatments for ear, nose, and throat (ENT) diseases. Spearheaded the setup of the new facility from the ground up, leading through PPQ. Created and meticulously reviewed manufacturing process technical documentation to ensure compliance with cGMP standards. Implemented comprehensive process flows to optimize production while maintaining regulatory adherence and quality. Supervised production and conducted statistical process control meetings at the clinical facility, ensuring robust tech transfer. Demonstrated expertise in process engineering and manufacturing science, driving continuous improvement and operational excellence.• Produced equipment lifecycle documents (CA, URS, SOP, etc.) and acted as the technical SME for review of manufacturing process documentation to support tech transfer to a large-scale commercial manufacturing site• Installed, configured, and optimized manufacturing equipment layout in a strict cleanroom environment• Implemented remote monitoring systems in cleanrooms and process equipment across two manufacturing sites• Provided upstream mfg. support, including change control, CAPA, deviation management, and report generation• Managed co-op in developing, validating, and deploying semi-automated data transfer software to enhance data integrity and expand the tooling program in a cGMP environment

Boston, Usa

Intrinsically interdisciplinary, and centrally located in a biotech hub, bioengineering at Northeastern is leading the way in bioimaging, cell and tissue engineering, biomechanics, and biomedical device advancement.

Kendall Square, Cambridge, Ma

Biopharmaceutical company focused on RNA interference (RNAi) therapeutics for genetically linked diseases• Supported mechanical testing of combination products valued at $10M for FDA approval• Generated and analyzed test data leading to approval of AMVUTTRA (Vutrisiran) RNAi therapeutic• Drug delivery lab: new test method development, validation, drug delivery system test and analysis• In-house design verification of pre-filled syringe & safety system to support clinical/commercial release• CAD modeling & 3D-printing of test fixture prototypes - technical drawings for machining/procurement

Watertown, Massachusetts, United States

• Manufactured phase 3 clinical drug products/devices following cGMP standards and FDA guidelines• Daily experience working in a clean room environment with strict regulation and quality control• Authored SOPs/IQs/OQs and executed written protocols for essential lab and production equipment• Operated/programmed vision system to inspect drug delivery system and troubleshot issues

Greater Boston Area

Digital pathology startup focused on multiplex biomarker assays for tissue imaging, phenotyping, and diagnostics• Fast-paced, early-stage environment with sudden changes in deadlines and goals• Assisted in the optimization of Ultivue's immunohistochemistry (IHC) kits for the identification of tissue immuno-oncology biomarkers in digital pathology• Designed and ran experiments to improve biomarker staining quality and kit stability• Independently ran complex IHC experiments on Leica BOND RX autostainer using high-value reagents• Used fluorescence microscopy techniques to image-stained tissue sections (Vectra Polaris/Zeiss AxioScan Z.1)• Segmented multiplexed images with HALO software and wrote Python scripts to automate workflow

Amherst, Ma, Usa

Lab duties related to the research of food-based, nano-structured delivery systems for bioactive components, including but not limited to:• Preparation of specimens such as cell cultures, that require the use of sterile techniques• Assistance to grad students in data collection (spectrophotometry, UV & particle size measurements) • Compiling data and performing basic statistical analysis in MS Excel• Maintaining lab equipment, checking inventory and sanitizing instruments after experimentationCo-Author of Curcumin study published in Science Direct: Kharat, M.; Skrzynski, M; Decker, E.A.; McClements, D.J. (2020). Enhancement of chemical stability of curcumin-enriched oil-in-water emulsions: Impact of antioxidant type and concentration. FOOD CHEMISTRY, 320, Article Number: 126653.

Northampton, Massachusetts

Provided customer service in a busy, fast-paced environment. Served food and beverages to clients. Cleaned restaurant and closed at night. Organized parking lot and collected parking fees.

Northampton, Ma

Working with groups of children age 5-10 at the People's Institue Summer Camp. Responsible for preparing art and small, interactive science projects. Instructing and monitoring various hands-on activities and take-home projects. Helping kids to enjoy and respect each other in a creative and safe environment.

Ludlow, Ma

Summer internship at digital premedia provider specializing in prepress & visualization - Created prototypes for various types of packaging (cartons, labels, pouches, bags)- Operated Kongsberg cutting table and inkjet printers, including file preparations- Assembled and organized samples for client’s sales presentations and focus groups

Master Of Engineering - Meng, Bioengineering And Biomedical Engineering

Activities and Societies: Tau Beta Pi

Bachelor Of Engineering - Be, Bioengineering And Biomedical Engineering

Activities and Societies: Tau Beta Pi, Northeastern Biomedical Engineering Society (BMES), Northeastern Real Estate Club (NURE).

High School Diploma

Activities and Societies: National Honor Society Member, Varsity Athlete and Co-Captain of the Tennis and Soccer Teams, Inventors.