Senior CMC Product Development Lead - Small Molecules

BioSpace; Boston (MA); Hybrid; USD 198,000 - 211,000; Full time

Benefits offered by this job

Health and wellness coverage

Paid time off

Hybrid schedule

Job summary

Beeline Medicines in Boston, MA seeks an Associate Director, CMC Product Development – Small Molecule to lead formulation and drug product development for clinical candidates. You will supervise cross‑functional teams, manage CDMOs, and drive DoE/QbD programs from early screening through Phase 3 and regulatory filings.

The role requires a PhD with 7+ years in small molecule development, strong communication, and a track record of delivering high‑quality CMC outcomes in biotech settings.

Qualifications

• Ph.D. in Pharmaceutical Sciences or closely related field.
• 7+ years in small molecule drug product development.
• Lead formulation and drug product development across multiple clinical phases.
• Deep solid oral dosage form development experience.
• Experience authoring IND/IMPD/NDA filings and regulatory responses.
• Proven ability to manage external partners including CDMOs.

Responsibilities

• Lead formulation development and drug product process development for small molecules.
• Oversee CDMO relationships and cross‑functional team oversight.
• Contribute to regulatory submissions and risk assessment workflows.
• Apply QbD/DoE to define CQAs, CPPs, and design spaces.
• Support clinical supply planning and tech transfer activities.

Skills

Program leadership

CDMO management

Regulatory submissions

Communication

Cross-functional collaboration

Problem solving

Education

Ph.D. in Pharmaceutical Sciences

Job description

Beeline Medicines in Boston, MA seeks an Associate Director, CMC Product Development – Small Molecule to lead formulation and drug product development for clinical candidates. You will supervise cross‑functional teams, manage CDMOs, and drive DoE/QbD programs from early screening through Phase 3 and regulatory filings.

The role requires a PhD with 7+ years in small molecule development, strong communication, and a track record of delivering high‑quality CMC outcomes in biotech settings.