Senior CMC Lead: Small Molecule Product Development

Beeline Medicines Corporation; Durham (NC); Hybrid; USD 199,000 - 258,000; Full time

Benefits offered by this job

Discretionary annual bonus

Long-term incentive / equity

Health benefits

Job summary

Beeline Medicines seeks a Director, CMC Product Development – Small Molecule to lead end‑to‑end drug product development from early formulation through process development, clinical supplies and regulatory submission. The role integrates with internal teams and external CDMOs, demanding deep expertise in small molecule formulation science and manufacturing, and the ability to balance strategy with hands‑on execution.

Hybrid work setup in the U.S.

Qualifications

• Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or related field.
• 10+ years in pharmaceutical small molecule drug product development and manufacturing.
• Proven lead for formulation and drug product development from early to late clinical phases.
• Expertise in solid oral dosage forms including immediate and modified release.
• Experience managing outside CDMOs and contract labs with oversight.
• Knowledge of ICH guidelines and FDA/EMA expectations.

Responsibilities

• Define and execute drug product development strategy for small molecule programs.
• Lead formulation development across all clinical phases, including excipient screening and final composition.
• Direct drug product process development, tech transfer, scale-up, and validation for solid oral dosage forms.
• Serve as primary technical interface with CDMO teams, overseeing scope and timelines.
• Author and review drug product sections of INDs, IMPDs, NDAs, and regulatory responses.
• Apply QbD and DoE to establish CQAs, CPPs, and design spaces.

Skills

Formulation development leadership

Cross-functional collaboration

Regulatory writing & submissions

Vendor management / CDMO oversight

Education

Ph.D. in Pharmaceutical Sciences or related field

10+ years in small molecule drug product development

Job description

Beeline Medicines seeks a Director, CMC Product Development – Small Molecule to lead end‑to‑end drug product development from early formulation through process development, clinical supplies and regulatory submission. The role integrates with internal teams and external CDMOs, demanding deep expertise in small molecule formulation science and manufacturing, and the ability to balance strategy with hands‑on execution.

Hybrid work setup in the U.S.