The Specification Lead is responsible for the creation, review, approval, revision, periodic review, and version control of specifications for intermediates, drug substance, drug product, and finished goods, and for ensuring that there is agreement on and justification that the acceptance criteria are phase-appropriate, justified, tighten appropriately as programs progress, and remain aligned with filed commitments and compendial requirements. Ensure acceptance criteria are phase-appropriate and scientifically justified, working collaboratively with Analytical and Process Development, Quality Control, CMC, and Regulatory Affairs as criteria are established and tightened from early phase through process validation and commercial supply.