A growing biotechnology company is seeking a fractional CMC Consultant to provide senior-level strategic guidance for the development of synthetic peptide drug products. This role will support CMC strategy and IND readiness, working in close partnership with internal technical leadership to advance programs toward first-in-human studies.
Responsibilities:
Provide strategic guidance on phase-appropriate CMC and analytical development
Advise on IND readiness and regulatory CMC strategy
Guide nonclinical and toxicology sequencing from a CMC perspective
Support selection and oversight of CROs and CDMOs
Review and test development plans for efficiency and regulatory soundness
Act as a strategic advisor rather than a hands-on developer
Requirements:
MS or PhD in Chemistry, Pharmaceutical Sciences, or a related field
Senior-level industry experience supporting CMC strategy for peptide or injectable drug products
Experience guiding programs through IND-enabling activities
Strong understanding of regulatory CMC expectations
Proven ability to advise cross-functional teams and external partners in a consulting capacity
