Nimish Dalal

About Nimish Dalal

Knowledgeable in cell culture from lab to manufacturing scale• Experienced in bacterial systems (1 through 300-L), and yeast systems (1 through 60-L)• Knowledgeable in aspects of regulatory guidelines that concern the manufacturing of biologic drug substance• Excellent interpersonal, communication, writing, and leadership skills

Experience

1. Senior Director, Head of Cell Therapy Drug Product Manufacturing Science and Technology

   Bristol Myers Squibb

   Sep 2024 — Present

   Key Responsibilities are • Lead a cross-functional team responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply at BMS’s multi-product Cell Therapy production facility. • Overseeing the Technical Strategy and Validation, Automation / MES, Manufacturing Technical Support, and Investigation teams. • Technical Strategy and Validation team: o Lead and Manage Life Cycle process changes and technical strategy implementation in coordination with cross functional groups and network cell therapy facilities. o Provides technical leadership for the commissioning, qualification, and validation of the manufacturing facility with a focus on clean room technology and Aseptic Qualification. o Partner with Facilities and Engineering to establish systems that will maintain a compliant, validated state the facility. • Automation and MES Team: o Supports the design, build, deploy, validate, and support both automation and execution systems in a regulated pharmaceutical manufacturing environment. o Leads the life cycle management and integration of electronic GMP manufacturing systems. • Manufacturing Technical Support Team: o Builds and maintains systems to continuously monitor, analyze, and optimize the end-to-end process performance. o Investigates and resolves issues that may arise during production. o Partners with QA and Manufacturing to ensure efficient and compliant cGMP systems to support manufacturing, including change control, investigations, etc. • Investigation team: o Provides technical support to site operations through determination of root cause investigations o Determination of suitable CAPA to prevent recurrence of events.

Education

• Penn State University

  B.S., Chemical Engineering

  1990 — 1994

• Penn State University

  Chemical Engineering

• University of Maryland

  M.S., Chemical Engineering

  1995 — 1998

• University of Maryland

  Ph.D., Chemical Engineering

  1998 — 2001

Skills

• Characterization
• Gmp
• Biologics
• Laboratory
• Biopharmaceuticals
• Biotechnology
• Fermentation
• Technology Transfer
• Capa
• Sop
• Bioreactor
• Commercialization