Process Development R D

SUSHAN D. SHEREGAR

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TECHNICAL SKILLS

Project Management, Smartsheet, MS Project, PowerBI, JMP, JKEM, Minitab, Epson RC+, DMAIC, A3, SolidWorks, Nuvolo, IBM Maximo, Arena PLM, Tableau, cGxP, ISO-5 Cleanroom, MES, Process Development, Validation, Manufacturing Operations EXPERIENCE

VERTEX CELL & GENE THERAPIES, BOSTON, MA

PROCESS DEVELOPMENT ENGINEERING SCIENTIST (NPI) NOV 2024-PRESENT

• Lead process engineering for new product introduction (NPI) by transferring drug product processes from R&D to GMP manufacturing, leading process characterization and automation upgrades.

• Develop and scale-up Drug Substance Drug Product manufacturing processes, optimizing aseptic fill operations for GMP production and Commercialization (URS, FMEA, Design Specification).

• Manage analytical investigations, deviations, and change controls related to drug product manufacturing and process controls.

• Lead process improvements (DOE, RCA, CAPA) and process validation (IQ, OQ, PQ, APS) efforts for drug substance encapsulation, ensuring robust, scalable, and regulatory-compliant processes. PROCESS DEVELOPMENT ENGINEERING SCIENTIST (DEVICE MANUFACTURING) AUG 2021-NOV 2024

• Led second shift engineering and trained technicians to support production on the first clinical manufacturing assembly line and pilot line using automated equipment that produces drug-device combination implantable devices.

• Facilitated scale-up and technology transfer from R&D to operations and CDMO’s to support IND submission of First- In-Human medical devices.

• Directed lean projects for chemical polymer coating process and robotic assembly processes and improved RTY from 1% to 20%.

• Created CMC clinical manufacturing processes, chemistry lab construction layout, MES workflows, preventative maintenance procedures, work instructions, and standard operating procedures using Quality management systems. INSULET CORPORATION, ACTON, MA

MANUFACTURING ENGINEER, CELL LEAD FEB 2020- AUG 2021

• Led a team of engineers and technicians to manage 24/7 production on 12 injection molding cells across 3 assembly lines of High-Volume Production equipment that produced insulin-delivering drug-device combination products.

• Supervised and managed a team of 5 interns, guiding and supporting them to complete improvement projects.

• Sustained daily production and increased RTY by 70% by designing new equipment and implementing LEAN principles resulting in a $204 million revenue increase.

• Developed PFMEA, DFMEA and executed process validation (SAT, FAT, IQ, OQ, PQ, TMV) on new assembly lines.

• Created WI’s and PM procedures and managed inventory reorder points and economic order quantities.

• Ran DoE’s and capability analysis using Minitab and JMP for process developments and developed prototypes using SolidWorks to improve an existing design.

• Led CAPAs and performed Root Cause Analysis of visual and dimensional defects of sub-assemblies and identified bottlenecks using OEE on fully Automated Robotic machines. GLOBAL MANUFACTURING ENGINEER CO-OP JAN 2019 – AUG 2019

• Created, managed, and executed process and test method validation (IQ, OQ, PQ, TMV), calibrations on fully automated robotic machines, and performed process capabilities (PpK, CpK, GR&R) at both the first American manufacturing plant and the supplier facility in Canada.

• Processed 50 Change Controls (ECOs), assembled a Device Master Record and BOM for Omnipods using Arena, and increased overall efficiency using GMP, Lean & Six Sigma concepts, resulting in a revenue increase of $6.5 million EDUCATION

CERTIFICATE IN STRATEGIC MANAGEMENT, HARVARD EXTENSION SCHOOL, Cambridge, MA DEC 2020 MASTER OF SCIENCE, INDUSTRIAL ENGINEERING, NORTHEASTERN UNIVERSITY, Boston, MA DEC 2019 Certificate in Supply Chain Management

BACHELOR OF SCIENCE IN AEROSPACE ENGINEERING, FLORIDA INSTITUTE OF TECHNOLOGY, Melbourne, FL MAY 2017 JESUS COLLEGE, OXFORD UNIVERSITY, Oxford, U.K., Jun – Aug 2015 PUBLICATIONS

Validation of Control Algorithm Using Formal Methods, IEEE Aerospace Conference, Big Sky, MT MAR 2017

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