Sam Ostrowski Email & Phone Number

San Diego, Ca, Us

San Diego, Ca, Us

Cambridge, Massachusetts, United States

In this role, I embraced and seamlessly transitioned between two distinct roles by leveraging skills in adaptability and resourcefulness to increase production output while maintaining a high level of attention to detailGMP Process Development Role - Implemented the scale-up of a nucleotide manufacturing process- Doubled the production cycle output from 60g to 120g - Optimized workflow processes, improved knowledge transfer, and leveraged advanced machinery to enhance overall efficiency and meet increased demand- Performed CAPAs to minimize failure and mitigate future risks through keen observation and detailed analysis to maintain compliance with quality standardsQuality Control Team Lead - Established quality control operations at the company’s global headquarters- Organized test planning and reporting for the scale-up project by collaborating with cross-functional teams and stakeholders, ensuring smooth execution and successful implementation - Oversaw in-process sample management by performing HPLC procedures and data modeling, guaranteeing accuracy and consistency of outputs and achieving high-quality standards - Managed quality control by tracking complex batch-to-batch data sets to predict equipment performance, resulting in sustained process repeatability and reproducibility

Cambridge, Massachusetts, United States

My role on this team was strategizing development pathways and executing engineering tasks to bring innovative technologies to market. This work stretched across three portfolio companies (Arctic Fox, BOA Biomedical, and Enso Surgical).Venture Analyst - Strategized business and product development pathways- Contributed to annual planning and Go-To-Market strategies- Employed an iterative development and test process to refine and enhance original ideas, resulting in the creation of intellectual property and enhancements to strategic plans- Maintained a pulse on market evolution to proactively identify and capitalize on growth opportunitiesSystems Engineering Lead - Led a cross-functional team by driving the development of an automated ELISA to meet growing business demands- Engineered customized fluidic handling sequences using a Dynex ELISA system by creating and modeling complex data sets to identify optimal execution, increasing lab throughput by 3x- Created clear and traceable requirements by analyzing stakeholder needs, technological capabilities, and environmental factors, measuring process efficiency, usability, and reliable assay performance- Executed installation and verification (IQ/OQ) by developing specialized test methods and building ad-hoc test fixtures to isolate subsystems and evaluate equipment performance- Qualified final instrument configuration (PQ) by validating diagnostic accuracy, system precision, and process robustness, as measured by performance over time, usability, and error handlingBiomedical Engineering Lead - Supported a Phase 1 Clinical Trial for the treatment of bloodstream infections- Managed filter production, sterilization, and bioburden testing by coordinating our efforts with suppliers to ensure timely execution and sustained product quality - Optimized lab workflows by managing batch record reviews, BOMs, lot comparison procedures, stock of materials, and sample analysis to enhance team execution and efficiency

Lexington, Ma

My role at this company was to contribute to the successful submission of a 510(k) report for a novel cryospray catheter used to treat COPD. I developed and executed verification and validation plans to allow for production level use of test fixtures that quantitatively characterized components of the catheter.

Depuy Synthes; Raynham, Ma

In this role I saw my initial exposure to the medical device research and development process. I wrote and composed documentation to smoothen design implementation, developed quality analysis procedures, coordinated and launched a project to reduce time and cost of a scope repair process, and trained colleagues to facilitate the global maintenance of a novel camera control system.

Warwick, Rhode Island, United States

My role included supervising client property and maintaining a high standard of excellence expected from over 200 club members. I trained and mentored new employees and guided teams in preparation for Club events and tournaments.

Master Of Science In Bioengineering, Medical Devices And Bioimaging

Bachelor Of Science In Bioengineering, Bioengineering And Biomedical Engineering