Kallol Biswas

About Kallol Biswas

Strong science does not guarantee execution.In regulated development and manufacturing environments, programs slow when technical, regulatory, and operational decisions start pulling in different directions. Teams stay busy, but progress becomes harder to measure.I work with regulated life science teams when complexity increases and programs risk losing momentum. My focus is helping teams clarify decisions, reduce cross-functional friction, and keep development and manufacturing moving without creating downstream regulatory risk.When teams typically bring me in• The same technical or regulatory decisions keep getting revisited• Timelines start slipping despite strong effort from the team• CMC, regulatory, and operational priorities conflict• Tech transfer, scale-up, or CDMO execution introduces friction• Leadership spends more time reacting than moving forward• Regulatory expectations create late-stage uncertaintyHow I help• Clarify decision ownership and unblock stalled progress• Bridge scientific, regulatory, and operational perspectives• Support practical decision-making during critical milestones• Maintain execution momentum without adding unnecessary processExperienceFDA, pharma, CRO, and PE-backed environments across development, regulatory, and manufacturing. Led global analytical and operational teams and supported complex programs through critical milestones.

Experience

1. Board Member

   Ohio Life Sciences Association

   Nov 2024 — Present

Education

• West Virginia University

  Master of Science - MS, Chemistry

  1995 — 1998

• West Virginia University

  B.A., Chemistry

  1991 — 1995

• Florida State University

  Doctorate, Chemistry

  1998 — 2002