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Immatics·7 days ago
7 days ago

Sr. Director, ATC Operations

Houston, United States of AmericaFull-timeRemoteSenior · 10-15 yearsCustomer Service Manager

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Must-have skills for this role

  • cellular therapy operations
  • chain of identity
  • chain of custody
  • apheresis

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Apply faster with autofill FREEThe NextRaise extension autofills your application in one click.careers.example.com/applyAutofillingFull namePriya SharmaEmailpriya.sharma@example.comPhone+49 30 1234567LocationBerlGet the extension

What you'll do

  • Design the anzu-cel 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.
  • Partner with Regulatory Affairs and Quality so the authorization approach is coherent with the risk-mitigation strategy described in the BLA and prepare for health authority questions on center oversight.
  • 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, while clearly defining and justifying any Immatics-specific requirements that remain necessary.
  • 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.
  • Partner cross-functionally to develop and deliver the anzu-cel treatment-center training curriculum for physicians, nurses, cell therapy coordinators, apheresis teams, and quality personnel.
  • Support manufacturer-side oversight of chain of identity and chain of custody at the treatment center, working with internal Immatics functions to ensure maintenance of COI/COC.
  • Define and verify center workflows for product receipt, cryogenic storage, thaw and administration; confirm labeling and identity verification controls are in place before activation.
  • Assess and provide treatment-center input into changes to collection, courier tracking, order intake and order processing that touch the center, and document the center-side impact of those changes.
  • Partner with Quality Assurance to support the management of quality records arising from treatment-center activities, including deviations, investigations, CAPAs, and change controls.

What they're looking for

  • 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.

Nice to have

  • 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 and 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

Summarised by NextRaise from the employer’s description, which follows in full below.

Full description from employer

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

Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics. 

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 and 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 chain of custody at the treatment center and ensure maintenance of COI/COC.

  • Define and verify center workflows for product receipt, cryogenic storage, thaw and administration.

  • Assess and provide treatment-center input into changes to collection, courier tracking, order intake and order processing.

Quality, compliance and audit

  • Partner with Quality Assurance to support the management of quality records arising from treatment-center activities, including deviations, investigations, CAPAs, and change controls.

Cross-functional launch readiness

  • Serve as the internal authority on treatment center operational readiness, partnering with Global Patient Supply, Quality, Manufacturing, Regulatory, Medical Affairs, Commercial, and IT.

  • Represent Immatics with accreditation bodies and cell therapy center consortia.

Leadership and team build

  • Define the field ATC operations model.

  • Build and lead a regional ATC Operations field team, including recruitment, onboarding, and capability development. Establish performance metrics for center authorization and operations

Travel required:

  • Ability to travel up to 40% domestically. Available for travel as needed to support and deliver ATC Authorizations to meet launch readiness timelines.

Immatics employees are encouraged to apply; internal candidates will be considered alongside external candidates. Qualified candidates will participate in a structured interview process, which includes:

  • An initial recruiter phone screen (conducted via video)

  • Interviews with the hiring leader and other key stakeholders (via video)

  • A final-stage interview

What do we offer?  

At Immatics, we believe in investing in our team’s health, safety and well-being. Here’s what you can expect if you join Immatics 

  

Comprehensive Benefits:  

  • Competitive rates for Health, Dental, and Vision Insurance 

  • 4 weeks of vacation, granted up front each year and prorated for first and last year of employment. 

  • 12 company paid holidays 

  • 7 days of sick time 

  • 100% employer-paid life insurance up to at 1x annual salary, up to one hundred thousand dollars  

  • 100% employer-paid short- and long-Term disability coverage  

  • 401(k) with immediate eligibility and company match… 

  • The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment. 

  • Partially paid parental leave for eligible employees. 

  • Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance.  

Equal Employment Opportunity 

We are an equal opportunity employer and are committed to building a diverse and inclusive workplace.  We consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, marital status, disability, genetic information, veteran status, or any other status protected by applicable law.   

 

Reasonable Accommodations 

We are committed to providing reasonable accommodations to individuals with disabilities and to applicants with sincerely held religious beliefs, practices, or observances.  If you require assistance or accommodation during the application or interview process, please contact us at RecruitingUS@immatics.com.   

 

Work Authorization 

Applicants must be authorized to work in the United States without the need for current or future sponsorship. 

 

Pre-Employment Requirements 

Employment is contingent upon successful completion of a background check, reference checks and pre-employment drug screening, where permitted by applicable law.  For certain roles, additional screenings such as a credit check or motor vehicle record review may be required, where job-related and consistent with business necessity.   

Company

Immatics
Houston, United States of America

Company facts come from this company's own listings. We only show what the postings themselves carry.

Sourced from Immatics's careers site·first seen 15 Sept 2026·last verified 16 Sept 2026·How we source jobs

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