Subject Matter Expert Consultant for Pharmaceutics / Formulation / Chemistry Manufacturing Control [CMC]

The National Institute on Drug Abuse (NIDA) within the Department of Health and Human Services is seeking subject matter expert consultants specializing in pharmaceutics, formulation, and chemistry manufacturing control (CMC) to support drug discovery and development programs including NIH Blueprint Neurotherapeutics, Help End Addiction Longterm (HEAL), and the NIH Biologics program. Consultants must possess a minimum of 15 years of experience, an advanced science degree, and extensive background in drug discovery and early development CMC efforts, with particular focus on neuroscience and pain treatment research. The contractor will provide strategic guidance on drug development processes, evaluate regulatory risks, recommend manufacturing strategies, and assist in preparing regulatory documentation through participation in Lead Development Team meetings. Technical evaluation will assess personnel qualifications worth 50 points across three sub-factors: professional experience in drug discovery and development, educational degrees and certifications, and collaborative team experience, with the award made on a best value basis weighing technical factors more heavily than price. Quotations are due by 12:00 PM Eastern Time on August 22, 2025, and must include key personnel resumes, qualification narratives, pricing templates, and past performance examples.

This procurement is set aside for small businesses under NAICS code 541690 with a size standard of $19 million, and no incumbent contractors are identified in the solicitation documents. The contract structure is a labor-hour purchase order with a base period from September 20, 2025, through September 19, 2026, anticipating a minimum of 20 annual support hours per consultant with optional hours up to 800 total hours per consultant annually. Salary rates are capped at Executive Schedule Level II, and the government may reimburse up to $1,500 in annual travel expenses per consultant. Performance will be conducted primarily at the contractor's site using remote communication methods including video conferences and email, with occasional potential on-site visits to the NIH facilities in Bethesda, Maryland. The solicitation is issued under FAR Part 13 Simplified Acquisition Procedures and FAR Part 12 for commercial items, indicating the total contract value will not exceed the simplified acquisition threshold.