Senior CMC Scientist — Small Molecule Process Chemistry

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

Benefits offered by this job

Health and Wellness

Paid time off

Hybrid schedule

Job summary

Beeline Medicines in the United States is seeking an Associate Director, CMC Synthetic Chemistry – Small Molecule to lead hands-on development, optimization, and scale-up of API routes. You will partner with CDMOs and cross-functional teams to advance candidates from development through GMP manufacture.

This role requires deep organic and process chemistry expertise, ability to work independently in a pre-commercial biotech environment, and strong communication with Regulatory, Quality, and IP

Qualifications

• Ph.D. in Organic Chemistry preferred or equivalent industry experience in pharmaceutical process development.
• 7+ years of API development and process chemistry in pharma/biotech.
• Experience leading synthetic chemistry programs from development to GMP manufacture.

Responsibilities

• Lead design, evaluation, and optimization of synthetic routes for APIs, ensuring robust, scalable manufacturing processes.
• Oversee process development campaigns from lab scale to kilo-lab and pilot plant operations.
• Interface with CDMO teams, reviewing batch records and addressing deviations quickly.
• Contribute to drug substance sections of regulatory filings and risk-based DoE studies.
• Collaborate on supplier qualification and IP strategy with cross-functional partners.

Skills

API process chemistry

CDMO collaboration

Scale-up experience

DoE studies

Education

Ph.D. in Organic Chemistry or equivalent experience

Job description

Beeline Medicines in the United States is seeking an Associate Director, CMC Synthetic Chemistry – Small Molecule to lead hands-on development, optimization, and scale-up of API routes. You will partner with CDMOs and cross-functional teams to advance candidates from development through GMP manufacture.

This role requires deep organic and process chemistry expertise, ability to work independently in a pre-commercial biotech environment, and strong communication with Regulatory, Quality, and IP