Director, Downstream Process Development & Tech Transfer

Marea Therapeutics; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Marea Therapeutics in South San Francisco is seeking a Director of Downstream Development to lead downstream process development from clinical to commercial scale, oversee tech transfer between CDMOs, and provide hands-on troubleshooting and data packages to support comparability and regulatory submissions.

Collaborating with drug product and analytical teams, you will develop and implement robust control strategies and contribute to CMC development for two programs in a lean startup setting.

Responsibilities

• Develop downstream process conditions with parameters aligned to the CDMO platform for monoclonal antibody manufacturing
• Identify, evaluate, and qualify unit operations, raw materials, equipment, sampling plans and in-process testing and control strategies
• Design and oversee studies for process optimization and cost-effective manufacturing
• Provide technical oversight of development and manufacturing activities at the CDMO
• Develop process and control strategies for consistent and reproducible drug substance manufacture
• Support deviations, OOS investigations, root cause analysis, and CAPAs as needed
• Manage troubleshooting activities as necessary

Job description

Marea Therapeutics in South San Francisco is seeking a Director of Downstream Development to lead downstream process development from clinical to commercial scale, oversee tech transfer between CDMOs, and provide hands-on troubleshooting and data packages to support comparability and regulatory submissions.

Collaborating with drug product and analytical teams, you will develop and implement robust control strategies and contribute to CMC development for two programs in a lean startup setting.