Associate Director Engineering - Commissioning, Qualification

Allogene Therapeutics

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Facilities | South San Francisco, CA | Full Time

Job Description

Allogene Therapeutics is a biotechnology company with a mission to catalyze the next revolution in cancer treatment through the development of allogeneic chimeric antigen receptor T-cell (CAR T) therapy directed at blood cancers and solid tumors. Founded and led by former Kite Pharma executives who bring unrivaled clinical development acumen in cell therapy, Allogene is well-positioned to further the potential of allogeneic cell therapy for patients.

Allogeneic CAR T therapies are engineered from cells of healthy donors and stored for “off-the-shelf” use in patients. This approach eliminates the need to create personalized therapy from a patient’s own cells, simplifies manufacturing, and reduces the time patients must wait for CAR T treatment. The Allogene portfolio includes 16 pre-clinical T cell therapy assets and UCART19, an allogeneic CAR T therapy currently in Phase 1 development for the treatment of acute lymphoblastic leukemia (ALL). Through its notable partnerships, Allogene leverages pioneering technology platforms, including TALEN® gene editing technology, to progress its portfolio of immuno-oncology therapies. Allogene, with headquarters in San Francisco, California, is a Two River portfolio company formed with one of the largest Series A financings in biotechnology from an investment consortium which includes TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer, and Pfizer. For more information, please visit www.allogene.com, follow @AllogeneTx on Twitter and LinkedIn.   

This position will report to the Head of Facilities and Engineering at Allogene Therapeutics and lead the efforts for establishing and sustaining programs for the South San Francisco laboratories and the manufacturing site in Newark, CA, regarding commissioning, qualification and asset life cycle management.  The responsible Associate Director of asset life cycle management will support many facets of the business requirements, associated with the Facilities and Engineering Departments support of the South San Francisco laboratories and manufacturing site.  You will lead the development and sustained functionality, regarding the activities associated with commissioning/qualification and life cycle management, for the South San Francisco and TBD manufacturing sites (including but not limited to programs, policies and other documentation related commissioning/qualification and asset life cycle management). 

Responsibilities include, but are not limited to:

  • Lead the implementation and execution of commissioning/qualification and asset life cycle management activities, based on your previous cGMP experience
  • Lead and/or support all projects associated with commissioning and qualification
  • Lead the development of all commissioning/qualification and life cycle management policies, programs and procedures
  • Lead the creation of SOP’s and other compliance related documentation as appropriate
  • Support the engineering project management build
  • Lead/support compliance requirements associated with commissioning and qualification
  • Build a sustainable commissioning/qualification and asset life cycle management program
  • Lead/support all activities, regarding the TBD manufacturing site, regarding the commissioning/qualification and asset life cycle management
  • Other duties as assigned
  • Bachelor’s degree in relevant field required
  • Strongly preferred start-up company experience in fast-growing environment
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
  • Ability to work independently and as part of a team
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
  • Candidates must be authorized to work in the U.S.

As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.

More Information

Type

Mid-level industry position

North%20America%2C%20South%20San%20Francisco%2C%20United%20States

North America

South San Francisco , United States

Location

United States

South San Francisco

Type

Mid-level industry position

North%20America%2C%20South%20San%20Francisco%2C%20United%20States