Sr. Director, ATC Operations

immatics; United States; Hybrid; USD 250,000 - 290,000; Full time

Job summary

Immatics is seeking a Senior Director, ATC Operations to lead the design and stand up the ATC authorization program across the US. You will build the program, lead a team, and activate the first wave of centers by launch readiness, with remote work flexibility and occasional on-site presence in Stafford, TX.

The role requires a clinical/biomedical degree, 12+ years in biotech/pharma, and 5+ years in cellular therapy operations, plus deep knowledge of FACT standards and COI/COC concepts.

Qualifications

• Bachelor's degree in a clinical, life sciences or healthcare administration field.
• 12+ years of relevant experience in biotechnology or pharmaceutical industry.
• 5+ years of direct experience in cellular therapy operations - either at a treatment center or in a manufacturer role authorizing and supporting treatment centers.
• Working knowledge of FACT Immune Effector Cell Standards, chain of identity and chain of custody requirements, and GTP/GMP concepts as they apply at the point of care.

Responsibilities

• Authorization framework design.
• Design the ATC authorization program: qualification criteria, risk-based assessment tooling, ongoing monitoring, requalification triggers, suspension or disqualification pathway, and ongoing monitoring plans.
• Develop the SOPs governing ATC authorization, authorized-user training and system access, product receipt and handling, and deviation escalation.
• Benchmark and harmonize treatment-center requirements with ASTCT 80/20 Task Force recommendations, FACT Immune Effector Cell Standards, existing center accreditation, and other manufacturer requirements.
• Center qualification and activation.
• Support the site selection and prioritization process; ATC target list, activation sequence and readiness tracker.
• Lead comprehensive remote and on-site treatment-center qualification assessments, evaluating readiness across clinical care, leukapheresis, cell processing, pharmacy, cryostorage, and toxicity-management infrastructure.
• Report ATC readiness into launch governance; own the authorization line on the integrated launch readiness plan and flag critical-path risk early and unambiguously.
• Training and authorized users.
• Partner cross-functionally to develop and deliver the treatment-center training curriculum for physicians, nurses, cell therapy coordinators, apheresis teams, and quality personnel.
• Lead delivery and documentation of treatment-center training, maintain the authorized-user registry, and oversee access to product ordering and chain-of-identity systems.
• Establish retraining triggers.
• Chain of identity (COI), chain of custody (COC) and product handling.
• Support manufacturer-side oversight of chain of identity and

Education

Bachelor's degree in a clinical, life sciences or healthcare administration field

Job description

Join Immatics and shape the future of cancer immunotherapy; one patient at a time!

Why Join Us?

• Innovative Environment: Help to pioneer advancements in cancer immunotherapy.
• Collaborative Culture: Be part of a diverse team dedicated to your professional growth.
• Global Impact: Contribute to therapies that make a lasting impact on patients globally.

Role Overview

We are seeking a Senior Director, ATC Operations to lead the design and stand up the Immatics Authorized Treatment Center (ATC) authorization program including the qualification standard, the SOPs, the training curriculum, the chain of identity and chain of custody controls, the ongoing monitoring and audit plans, and lead the execution across the US authorized treatment center network. The program will be designed and operated in partnership with other areas, including but not limited to Global Patient Supplies and Global Quality Operation. The successful candidate will design and build the program and lead a team to activate the first wave of ATCs by launch readiness, and grow a team to sustain the ongoing authorization pipeline.

Reports to: VP, Launch Excellence, Strategy, & Operations

Location: Fully Remote (with as-needed on-site presence at Immatics US, Stafford, TX)

Salary Range: $250,000 - $290,000

Basic Qualifications

• Bachelor's degree in a clinical, life sciences or healthcare administration field
• 12+ years of relevant experience in biotechnology or pharmaceutical industry
• 5+ years of direct experience in cellular therapy operations - either at a treatment center (cell therapy program management, apheresis, cell processing laboratory, IEC quality, or transplant/cell therapy nursing) or in a manufacturer role authorizing and supporting treatment centers.
• Working knowledge of FACT Immune Effector Cell Standards, chain of identity and chain of custody requirements, and GTP/GMP concepts as they apply at the point of care.

Preferred Qualifications

• An advanced clinical degree (MSN, MHA, PharmD, MPH)
• Clinical background (e.g., RN, NP, PA, PharmD, MSW)
• Experience building an authorization or site qualification program
• Launch experience with an autologous cell therapy, including the first wave of center activations
• Hands-on experience with leukapheresis workflows and treatment-center operations for cell therapy
• Demonstrated leadership & ownership of treatment center qualification, onboarding, training, and/or audit activities across commercial-stage or late-stage clinical cell or gene therapy programs.
• In-depth understanding of treatment center workflows, cell therapy coordination, apheresis, and chain-of-identity / chain-of-custody logistics
• Working knowledge of ASTCT 80/20 Task Force guidance, FACT accreditation and inspection processes, and/or center-level REMS implementation
• Track record of writing SOPs and quality documentation and of handling deviations and CAPAs.

In this role you will be responsible for:

• Authorization framework design
• Design the ATC authorization program: qualification criteria, risk-based assessment tooling, ongoing monitoring, requalification triggers, suspension or disqualification pathway, and ongoing monitoring plans.
• Develop the SOPs governing ATC authorization, authorized-user training and system access, product receipt and handling, and deviation escalation.
• Benchmark and harmonize treatment-center requirements with ASTCT 80/20 Task Force recommendations, FACT Immune Effector Cell Standards, existing center accreditation, and other manufacturer requirements.
• Center qualification and activation
• Support the site selection and prioritization process; ATC target list, activation sequence and readiness tracker.
• Lead comprehensive remote and on-site treatment-center qualification assessments, evaluating readiness across clinical care, leukapheresis, cell processing, pharmacy, cryostorage, and toxicity-management infrastructure.
• Report ATC readiness into launch governance; own the authorization line on the integrated launch readiness plan and flag critical-path risk early and unambiguously.
• Training and authorized users
• Partner cross-functionally to develop and deliver the treatment-center training curriculum for physicians, nurses, cell therapy coordinators, apheresis teams, and quality personnel. Lead delivery and documentation of treatment-center training, maintain the authorized-user registry, and oversee access to product ordering and chain-of-identity systems. Establish retraining triggers.
• Chain of identity (COI), chain of custody (COC) and product handling
• Support manufacturer-side oversight of chain of identity and