Director, CMC Product Development - Small Molecule

The role

The Director, CMC Product Development - Small Molecule is a senior technical and operational leader responsible for end-to-end CMC development of small molecule drug product candidates. This role drives drug product development activities from early formulation through process development, clinical supplies, and regulatory submission.

What you will do

• Define and execute drug product development strategy for assigned small molecule programs.
• Lead formulation development activities for small molecule drug candidates across all clinical phases.
• Direct and oversee drug product process development, technical transfer, scale-up, and validation.
• Serve as the primary technical interface with CDMO drug product teams.
• Author and review drug product sections of regulatory submissions including IND, IMPD, NDA, and MAA.
• Lead technical response to FDA and EMA questions on drug product topics.
• Integrate Quality by Design (QbD) principles and Design of Experiments (DoE) into development decisions.
• Collaborate with Analytical Development to define release and stability specifications.
• Lead packaging development and container-closure system selection.
• Contribute to clinical supply planning and CMC due diligence assessments.

Required qualifications

• 10+ years of pharmaceutical drug product development and manufacturing experience focused on small molecules.
• 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.
• Proven experience in selecting and managing external partner relationships (CDMOs and contract laboratories).
• Comprehensive 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.
• Proven track record of operating effectively in a pre-commercial, resource-constrained environment.
• Experience managing cross-functional stakeholder relationships at the senior level.
• Strong written and verbal communication skills.
• Effective collaborator with a track record of building productive working relationships across CMC functions, Clinical Development, Clinical Pharmacology, Regulatory Affairs, and Quality.

Nice to have

• Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a closely related discipline preferred, or equivalent industry experience.

Benefits

• Competitive health and wellness coverage
• Paid time off
• Public holidays
• Additional leave entitlements in accordance with local requirements

About the company

Beeline Medicines is a clinical-stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases.