Biologics CMC Product Development Director (Hybrid)

BioSpace; Boston (MA); Hybrid; USD 217,000 - 227,000; Full time

Benefits offered by this job

Hybrid schedule

Discretionary bonus

Equity

Job summary

Beeline Medicines in the United States seeks a Director, CMC Product Development – Biologics to lead end-to-end drug product development for large molecule programs (monoclonal antibodies, fusion proteins).

You will drive formulation and fill‑finish development, manage CDMO partnerships, and coordinate regulatory submissions (IND, BLA) with Quality, Clinical Operations, and Regulatory teams.

Qualifications

• Ph.D. required or equivalent work experience.
• 10+ years of CMC biologics experience in pharma/biotech.
• Deep expertise in biologics formulation, stability, and container-closure systems.
• Strong knowledge of ICH Q8/Q9/Q10/Q11 and FDA/EMA CMC expectations.
• Experience managing biologics CDMOs for fill-finish and scale-up.
• Experience with lyophilized and liquid formulations for parenteral biologics.

Responsibilities

• Define and execute biologics drug product development strategy, including formulation and fill‑finish.
• Lead formulation development activities and stability studies for protein therapeutics.
• Oversee drug product process development, scale-up, tech transfer, and QC readiness.
• Author regulatory sections for IND/BLA and support FDA/EMA interactions.
• Select and manage CDMO partners for biologics drug product manufacture.
• Collaborate with Analytical Development on release specs and comparability strategies.
• Ensure uninterrupted clinical supply across trials and manage packaging/logistics.
• Incorporate QbD, DoE, and risk management into development decisions.
• Evaluate novel delivery technologies and device requirements for biologics.
• Contribute to due diligence and portfolio planning for manufacturability.

Skills

Cross-functional leadership

Regulatory strategy

Biologics formulation

Process scale-up

CDMO management

Education

Ph.D. in Pharmaceutical Sciences or related field

Job description

Beeline Medicines in the United States seeks a Director, CMC Product Development – Biologics to lead end-to-end drug product development for large molecule programs (monoclonal antibodies, fusion proteins).

You will drive formulation and fill‑finish development, manage CDMO partnerships, and coordinate regulatory submissions (IND, BLA) with Quality, Clinical Operations, and Regulatory teams.