Senior CMC Scientist: Small Molecule Synthesis

Beeline Medicines; Durham (NC); Hybrid; USD 200,000 - 258,000; Full time

Job summary

Beeline Medicines seeks an Associate Director, CMC Synthetic Chemistry – Small Molecule to lead design, development, and scale‑up of APIs. The role interfaces with CDMOs, supports IND/IMPD/NDA submissions, and drives robust process control in a pre‑clinical/clinical biotech setting.

The position offers hybrid work with on‑site days twice weekly and collaboration across CMC, Regulatory Affairs, and Quality to advance programs on schedule.

Qualifications

• Ph.D. in Organic Chemistry preferred; or equivalent industry experience in pharmaceutical process development.
• 7+ years of API development and process chemistry in pharmaceutical/biotechnology.
• Led synthetic chemistry programs from development through GMP manufacture.
• Deep expertise in designing and optimizing synthetic routes for complex small molecule APIs.
• Hands-on experience at CDMO sites with batch records, troubleshooting, and scale-up.
• Proficient with cGMP expectations for drug substance manufacture.
• Experience authoring drug substance sections of INDs/IMPDs/NDA filings.
• Strong communication and collaboration across CMC, Regulatory Affairs, Quality, and Clinical Development.
• Organized, detail-oriented, and capable of managing competing priorities and timelines.

Responsibilities

• Lead design, evaluation, and optimization of synthetic routes for small molecule APIs.
• Oversee process development campaigns from lab scale to kilo-lab and pilot plant.
• Interface with CDMO process chemistry teams and review batch records.
• Contribute to regulatory filings with synthesis route descriptions and development summaries.
• Design and execute DoE studies to define parameters and control strategy.
• Perform hazard assessments and scale-up risk analyses with safety and engineering peers.
• Oversee sourcing and qualification of starting materials and reagents.
• Collaborate cross-functionally to advance programs on schedule.

Skills

Organic chemistry

Process chemistry

CDMO management

DoE studies

Scale-up

Regulatory filings

Education

Ph.D. in Organic Chemistry

Equivalent industry experience

Job description

Beeline Medicines seeks an Associate Director, CMC Synthetic Chemistry – Small Molecule to lead design, development, and scale‑up of APIs. The role interfaces with CDMOs, supports IND/IMPD/NDA submissions, and drives robust process control in a pre‑clinical/clinical biotech setting.

The position offers hybrid work with on‑site days twice weekly and collaboration across CMC, Regulatory Affairs, and Quality to advance programs on schedule.