What are the responsibilities and job description for the Senior Director, External Manufacturing position at Initial Therapeutics, Inc.?
About Obsidian Therapeutics
Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies.
We apply our cytoDRiVE platform technology to express regulated therapeutic proteins to enhance anti-tumor activity. Our programs investigate OBX-115 and enroll patients in an ongoing multicenter clinical trial in advanced melanoma and non-small cell lung cancer (Agni-01).
We're proud of our diverse talented team and committed to cultivating an environment where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work.
Our Opportunity
This position is responsible for leading the oversight of Obsidian's network of contract development and manufacturing organizations (CDMOs) inclusive of cell therapy drug substance / drug product and viral vector drug substance production for both clinical phase and commercial phase products.
The Manufacturing Head provides leadership, strategic thinking, and results focus to reliably meet and/or exceed the company's manufacturing goals while maintaining high levels of quality. The role partners with internal and external stakeholders to drive direct production activities as well as support activities including batch record / SOP management, production scheduling, deviation investigations, change management, and training all according to current good manufacturing practices (cGMP).
Responsibilities
Requirements
Bonus qualifications