Aatish Patel Email & Phone Number

Boston, MA, US

Marlborough, Massachusetts, US

Nussloch, DE

• Contributed to CDx projects as a technical lead. Successfully collaborated with cross-functional teams, ensuring on-time project delivery and reporting progress and outcomes to clients.
• Directed and managed the assay team to develop assays for CDx products and drove the teams to deliver results on time and within budget.
• Generated and reviewed feasibility, development, verification and validation (V&V) plans, protocols, deviations, reports and other technical documentation under design control.
• Supported CAP/CILA validation efforts by executing assay transfer tasks, including operator training, sample preparation, and protocol review for accuracy.
• Worked closely with the regulatory departments for Premarket Approval (PMA) and Performance Study Application (PSA) regulatory submissions.
• Led risk review of IVD devices by authoring risk management plans and reports and organized risk review sessions to assess, evaluate, and control potential risks associated with the IVD device using a risk management.

Nussloch, DE

• Worked closely with technical leads to develop and execute feasibility, development, and verification studies to support the development of CDx immunohistochemistry (IHC) and in situ hybridization (ISH) assays.
• Prepared comprehensive study protocols and reports, ensuring adherence to quality standards and regulatory requirements.
• Conducted training sessions for internal and external testing sites on implementing and using of CDx assays, fostering effective adoption and utilization.
• Made significant contributions to the preparation of design control documents, ensuring robust documentation and compliance with industry and regulatory standards.
• Demonstrated expertise in troubleshooting and optimizing experimental procedures, enhancing overall project efficiency and success rates.

Lawrence Township, NJ, US

• Developed IHC assays using automated (Leica Bond Rx and Biocare Intellipath) and manual platforms for cancer research and pre-clinical purposes.
• Conducted image analysis using HALO software for data interpretation.
• Labeled antibodies with FITC.
• Proficient in mammalian cell culturing, in-vitro cell-based assays, and scanning IHC stained slides using a Leica Aperio AT2 scanner.

Lawrence Township, NJ, US

• Maintained healthy cell lines and processed cells to prepare frozen and Formalin-Fixed and Paraffin-Embedded (FFPE) blocks for utilization in IHC and ISH assay as controls.
• Conducted mammalian cell culturing and in-vitro cell-based assays.
• Performed automated IHC using Leica BOND Rx and Biocare Intellipath.
• Labeled antibodies with FITC.

Melbourne, Florida, US

• Designed a tissue-engineered vascular graft by incorporating a therapeutic molecule. Investigated the effect of this molecule on endothelial cells to enhance the development of a functional endothelium within the graft.
• Designed experimental plan to develop research strategies.
• Fabricated drug-loaded electrospun scaffolds and characterized by using SEM for vascular engineering applications.
• Developed the protocol to track drug releases from the electrospun scaffolds and used UV/VIS spectrophotometry to analyze drug release profiles.
• Maintained mammalian cell cultures, and troubleshooted for improved cell attachment on scaffolds.
• Troubleshoot to get improved cell attachment on the electrospun scaffolds.