Director, Small Molecule CMC (Hybrid)

Beeline Medicines; North Carolina; Hybrid; USD 199,000 - 258,000; Full time

Benefits offered by this job

Hybrid work schedule

Job summary

Beeline Medicines seeks a Director, CMC Product Development – Small Molecule to lead end‑to‑end drug product development, from formulation and process development through clinical supplies and regulatory submission, working cross‑functionally with internal teams and external CDMOs in a pre‑commercial biotech setting. The role requires a Ph.D.

and 10+ years in small molecule development, with a track record on IND/IMPD/NDA filings, QbD/DoE, and packaging decisions, plus a hybrid work arrangement

Qualifications

• Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or closely related discipline preferred, or equivalent industry experience.
• 10+ years of pharmaceutical drug product development and manufacturing experience focused on small molecules.
• Proven track record as primary scientific lead on formulation and drug product process development programs from early to late clinical phases.
• Deep expertise in solid oral dosage form development (IR, MR, amorphous solid dispersions).
• Experience with external CDMOs, change control, deviation resolution, and performance monitoring.

Responsibilities

• Define and execute drug product development strategy for small molecule programs.
• Lead formulation development activities across all clinical phases.
• Direct drug product process development, tech transfer, scale‑up, and validation.
• Act as primary technical interface with CDMO teams and ensure quality/timeline commitments.
• Contribute to regulatory submissions (IND/IMPD/NDA) with formulation and manufacturing narratives.

Job description

Beeline Medicines seeks a Director, CMC Product Development – Small Molecule to lead end‑to‑end drug product development, from formulation and process development through clinical supplies and regulatory submission, working cross‑functionally with internal teams and external CDMOs in a pre‑commercial biotech setting. The role requires a Ph.D.

and 10+ years in small molecule development, with a track record on IND/IMPD/NDA filings, QbD/DoE, and packaging decisions, plus a hybrid work arrangement