Director of Cell Line and Upstream Process Development - Remote

Overview

Disc Medicine is hiring a new Director, Cell Line and Upstream Process Development due to the fast growth of the company’s portfolio. The successful candidate will serve as the functional lead for both Cell Line Development and Upstream Process Development for Disc Medicine’s biologics program pipeline, including early and late-stage development through Process Characterization and Process Performance Qualification (PPQ).

In Short

• Spearhead late-stage development for upstream processes.
• Lead upstream process validation strategy and documentation.
• Function as key SME resource for regulatory documents.
• Evaluate drug substance CDMOs and service providers.
• Support negotiations on Master Service Agreements and contracts.
• Oversee external operations for Cell Line Development.
• Function as Person-in-Plant for manufacturing campaigns.
• Lead early-stage upstream development efforts at CDMOs.
• Review and approve technical development reports and quality documents.
• Report progress to senior leadership and present data at conferences.

Requirements

• PhD in biology, biochemistry, or related discipline.
• Minimum 10 years of industry experience.
• Experience with Scale-Down Model Verification and Process Characterization.
• Deep experience with statistical software tools such as JMP.
• Managerial experience leading staff is desired.

Benefits

• Comprehensive benefits package.
• Competitive compensation packages.
• Flexible work environment.
• Opportunities for professional development.
• Inclusive company culture.