Director, CMC Product Development – Small Molecule (Hybrid)

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

Job summary

Beeline Medicines is seeking a Director of CMC Product Development – Small Molecule to lead end-to-end drug product development from formulation through regulatory submission. This role requires deep formulation science, scale-up expertise, and strong cross-functional leadership in a pre-commercial biotech setting.

The candidate will head CMC strategies, collaborate with CDMOs, and guide IND/IMPD/NDA submissions, while integrating QbD and DoE to ensure robust, compliant product development

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 in pharmaceutical or biotechnology industry.
• Demonstrated track record of serving as the primary scientific lead on formulation and drug product process development programs from early to late clinical phases.
• Deep technical expertise in solid oral dosage form development (immediate release, modified release, amorphous solid dispersions).
• Proven experience in selecting and managing external partner relationships (CDMOs and contract laboratories).
• Knowledge of ICH Q8/Q9/Q10/Q11, cGMP requirements and FDA/EMA drug product development expectations.
• Experience authoring drug product sections of INDs, IMPDs, and NDA filings.

Responsibilities

• Define and execute drug product development strategy for small molecule programs.
• Lead formulation development across all clinical phases, including excipient screening and optimization.
• Oversee drug product process development, transfer, scale-up, and validation for solid oral dosage forms.
• Serve as primary technical interface with CDMO teams, defining scope and ensuring quality and timeline commitments.
• Author and review regulatory submissions related to drug product and respond to health authority questions.
• Apply QbD and DoE to establish CQAs, CPPs, and design spaces.
• Collaborate with Analytical Development on release specs and stability.
• Lead packaging development and container-closure system decisions.
• Support clinical supply planning with timelines and batch projections.
• Evaluate delivery technology options and contribute to candidate selection.
• Contribute to CMC due diligence and portfolio planning.

Skills

CMC leadership

Regulatory document writing

Cross-functional collaboration

Pharmaceutical formulation

Vendor management

Strategic planning

Education

Ph.D. in Pharmaceutical Sciences or related field

Job description

Beeline Medicines is seeking a Director of CMC Product Development – Small Molecule to lead end-to-end drug product development from formulation through regulatory submission. This role requires deep formulation science, scale-up expertise, and strong cross-functional leadership in a pre-commercial biotech setting.

The candidate will head CMC strategies, collaborate with CDMOs, and guide IND/IMPD/NDA submissions, while integrating QbD and DoE to ensure robust, compliant product development