Senior Associate Director, Small Molecule CMC (Hybrid)

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

Benefits offered by this job

Hybrid work schedule

Job summary

Beeline Medicines is seeking an Associate Director, CMC Product Development – Small Molecule to lead formulation and drug product development for clinical supplies, spanning from early development through Phase 3. The role requires hands-on expertise and independence in a pre-commercial biotech environment.

The position emphasizes CDMO management, cross-functional alignment with CMC, Regulatory, and Quality, and contribution to IND/IMPD/NDA filings with a focus on solid dosage forms and DoE/QbD

Qualifications

• Ph.D. in Pharmaceutical Sciences or closely related discipline preferred or equivalent industry experience.
• 7+ years of pharmaceutical drug product development focused on small molecules.
• Experience leading formulation and drug product development across multiple clinical phases.

Responsibilities

• Lead formulation development for small molecule drug candidates across clinical phases.
• Oversee drug product process development and scale-up for solid oral dosage forms and other delivery formats.
• Serve as primary technical interface with CDMO drug product teams and cross-functional CMC groups.
• Contribute to regulatory submissions (IND/IMPD/NDA) including DP sections and control strategies.
• Apply QbD and DoE to establish CQAs and CPPs; manage stability programs and packaging development.

Skills

Small molecule formulation

CDMO oversight

Drug product development

IND/IMPD/NDA filings

QbD and DoE

Regulatory submissions

Cross-functional collaboration

Packaging development

Program management

Education

Ph.D. in Pharmaceutical Sciences

Job description

Beeline Medicines is seeking an Associate Director, CMC Product Development – Small Molecule to lead formulation and drug product development for clinical supplies, spanning from early development through Phase 3. The role requires hands-on expertise and independence in a pre-commercial biotech environment.

The position emphasizes CDMO management, cross-functional alignment with CMC, Regulatory, and Quality, and contribution to IND/IMPD/NDA filings with a focus on solid dosage forms and DoE/QbD