Senior Director, Drug Product Development & Manufacturing — Flexible

Apnimed; Cambridge (MA); On-site; USD 210,000 - 320,000; Full time

Benefits offered by this job

401(k) with company match

Generous vacation time

Flexible working environment

Motivated and experienced team

Best Places to Work 2024/2025

Job summary

Apnimed is seeking a Senior Director of Drug Product Development and Manufacturing in Cambridge, MA. The role leads formulation development and manufacturing of small-molecule solids, coordinating with CDMOs to ensure reliable clinical and commercial supply while guiding regulatory filings.

You will drive lifecycle management, support IND/NDAs, and partner with Quality, Regulatory, Supply Chain, and Commercial to shape strategy for a first‑in‑class sleep apnea treatment.

Qualifications

• Bachelor or higher degree in a relevant science/engineering field.
• 10+ years in pharma/biotech with small-molecule development and manufacturing experience (MS or PhD preferred).
• Experience managing external CDMOs, tech transfers, clinical supply and commercial launch.

Responsibilities

• Lead drug product formulation development and manufacturing in a cGMP environment with external partners.
• Evaluate manufacturing changes for regulatory impact and provide strategic guidance.
• Support CMC across INDs, IMPDs, NDAs, and MAAs with cross-functional teams.
• Manage cross-functional CMC teams with QA, Regulatory, Supply Chain, and Clinical.
• Review manufacturing docs including development and campaign reports.

Skills

Leadership

External CDMO management

Strategic planning

Cross-functional collaboration

Communication

Problem solving

Independent work

Education

Degree in Pharmaceutical Sciences, Life Sciences, Engineering, or related

Tools

MS Word

PowerPoint

Excel

Outlook

Job description

Apnimed is seeking a Senior Director of Drug Product Development and Manufacturing in Cambridge, MA. The role leads formulation development and manufacturing of small-molecule solids, coordinating with CDMOs to ensure reliable clinical and commercial supply while guiding regulatory filings.

You will drive lifecycle management, support IND/NDAs, and partner with Quality, Regulatory, Supply Chain, and Commercial to shape strategy for a first‑in‑class sleep apnea treatment.