CTRL Therapeutics Director/Sr. Director, Cell Therapy Manufacturing Chicago, IL · San Francisco, CA · Remote · Full time

Apply for Director/Sr. Director, Cell Therapy Manufacturing

Location: San Francisco, Chicago, or Remote

About us:

We are building a new company to transform the cell therapy space by developing autologous cell therapies for patients with solid tumors. We are building a company culture based on collaboration, transparency, integrity, and commitment to excellence. We are looking for passionate people to be a part of this journey.

What you'll do:

As the first Manufacturing professional at cTRL Tx, you will have a unique opportunity to work with our interdisciplinary team to drive and oversee the technical and operational aspects of our process development, GMP workflow, CDMO collaboration, logistics, and FIH preparation, among others.

This position is integral to our company and involves regular collaboration with internal and external stakeholders.

Reporting to the CEO, you will assist in developing and building our manufacturing function for the future and providing technical and operational leadership, as well as the primary contact and overseeing our work with an external CDMOs.

Key Responsibilities:

• Collaborate with cTRL leadership, regulatory experts and our CDMO to design strategies and provide technical/CMC guidance for IND submission and clinical trials for our first and future products.
• Establish and manage process improvements through data-driven insights (e.g., scheduling enhancements and optimization, manufacturing process improvements).
• Facilitate seamless communication between stakeholders and internal teams to ensure clarity throughout the manufacturing lifecycle, setting standards and driving smart, continuous improvements.
• Lead the development of compliance and regulatory product specifications.
• Monitor and maintain the budget for manufacturing activities and drive project timelines.
• Plan, lead, design and build-up various activities beyond direct product manufacturing, including technical, quality, supply chain, manufacturing, QC, packaging, and logistics.
• Author technical documents for regulatory agency submissions in support of manufacturing processes and may serve as a process subject matter expert in authority interactions.

• Collaborate with CROs and external partners to ensure the successful manufacture of products required for clinical development and partnerships.
• Offer technical and operational input/feedback to the research team for best practices and improvements.
• Work closely with manufacturing partners and internal teams to develop quality controls, processes, and systems that facilitate compliant and successful technology transfers, operations, and lifecycle management.
• Facilitate timely decision-making, active communication, and information exchange between the partners and cTRL Tx team members.
• The ideal candidate can be in San Francisco, Chicago, or remote with the ability to travel to these cities and our CDMO location in the US, visit customers, and collaborate with R&D, Engineering, and other functional teams.

You should have:

• Bachelor’s degree in life sciences, engineering, or related field and eight or more years of industry experience; master's degree with 5+ or more years of experience; Ph.D. and 2-3 years of experience.  In-depth knowledge of cell therapy in general and TILs/TCR T’s, specifically, is preferred.
• Must have 5+ years industry experience in Cell Therapy development, CDMO or manufacturing. First-hand experience with GMP manufacturing is a plus.
• Must have experience working with departmental and/or cross-functional peers to coordinate and execute on complex projects.
• Previous experience with INDs and BLAs is preferred.
• You are self-motivated and can thrive in a dynamic, fast-paced startup environment.

Notes:

Titles associated with offers are based on cumulative experience and are at the discretion of the hiring committee.

What we offer: 

Compensation: A competitive salary in addition to equity.

Benefits: Health, Dental, and Vision insurance, FHA, 401(k), commuter benefits

At CTRL, we embrace the different backgrounds, perspectives, and experiences our team members bring. As a proud Equal Opportunity Employer, we welcome all applicants and teammates regardless of race, color, ancestry, national origin, religion or religious creed, mental or physical disability, medical condition, genetic information, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity, gender expression, age, marital status, military or veteran status, citizenship, or other characteristics protected by applicable law. If you need assistance or accommodation due to a disability, please contact us.