Lead, Small Molecule CMC Product Development

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

Job summary

Beeline Medicines is seeking a Director, CMC Product Development – Small Molecule. Lead end-to-end development from formulation to regulatory submission, partnering with CDMOs and internal teams.

The role demands deep expertise in solid oral dosage forms, QbD/DoE, and a proven track record in pre-commercial settings. Hybrid work with approx. two on-site days weekly and potential travel.

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.
• Primary scientific lead on formulation and drug product process development from early to late clinical phases.
• Deep expertise in solid oral dosage form development (IR, modified release, amorphous solid dispersions).
• Experience managing external partners (CDMOs, contract labs) with oversight and change control.
• Knowledge of ICH Q8/Q9/Q10/Q11, cGMP, FDA/EMA expectations for drug product development.
• Experience authoring drug product sections of INDs/IMPD/NDA filings and responding to authorities.
• Proven ability to operate in a pre-commercial, resource-constrained environment.
• Strong cross-functional stakeholder management and executive communication.
• Willingness to travel ~20%+ as needed.

Responsibilities

• Define and execute drug product development strategy for small molecule programs.
• Lead formulation development across all clinical phases and select final composition.
• Direct drug product process development, tech transfer, scale-up, and validation.
• Interface with CDMO teams, overseeing scope, quality, and timelines.
• Author/Review regulatory sections on drug product topics and respond to authorities.
• Apply QbD and DoE to establish CQAs, CPPs, and design spaces.
• Collaborate with Analytical Development on release and stability specs.
• Lead packaging development and container-closure system selection.
• Support clinical supply planning with timelines and batch projections.
• Evaluate dosage form strategies and manufacturability in candidate selection.
• Contribute to CMC due diligence and portfolio planning.
• Perform other duties as assigned.

Skills

Formulation development

Drug product development

CDMO management

Regulatory submissions

QbD & DoE

Cross-functional leadership

Project management

IND/IMPD/NDA/NDA filings

cGMP knowledge

Travel 20%+

Education

Ph.D. in Pharmaceutical Sciences or related

Job description

Beeline Medicines is seeking a Director, CMC Product Development – Small Molecule. Lead end-to-end development from formulation to regulatory submission, partnering with CDMOs and internal teams.

The role demands deep expertise in solid oral dosage forms, QbD/DoE, and a proven track record in pre-commercial settings. Hybrid work with approx. two on-site days weekly and potential travel.