Facility Manager, GMP Maintenance & Calibration

Kite Pharma   •  

Gaithersburg, MD

8 - 10 years

Posted 187 days ago

Job Description

Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells.  Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies.  We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer patients.

We are seeking a highly motivated individual to join us as a facility manager of a new research and clinical production facility located in Gaithersburg, Maryland.  This facility will focus on the new challenging field of fully personalized T cell neoantigen reactive therapy for solid tumors using individual patient neoantigen TCRs.  Reporting to the Head of Technical Operations this manager position ensures critical day to day running of the facility infrastructure to support both fast pace research and clinical production capability.  This will include driving the facility start up objectives and longer term operation goals to ensure flexible, responsive and reliable operations to deliver challenging new cures to patients.

Responsibilities (include but are not limited to):

  • Managing of all facility infrastructure requirements for research and clinical production.  This includes ensuring facility utilities are 100% operational and maintained to support critical day to day, operation of clinical GMP production of engineered Tcells & QC lab capability.
  • Lead the startup of facility infrastrastructure and utilities, particularly in support of critical qualification and validation activities of the new clinical production suites. 
  • Develop and lead the maintenance plan for facility infrastructure and utilities including its associated budget.
  • Leads and hands on resolution and repair of facility support systems safely and expeditiously maintains up-to-date records for all local, state and GMP requirements.
  • Develop and execute plans for calibration and maintenance of production and laboratory equipment, BMS, utilities, including compressed gases, liquid nitrogen, temperature controls, production controls and HVAC
  • Define and manage external supplier relationships for utilities maintenance partners and site support services including landlord tenant issues. 
  • Leads and develops the EH&S facility requirements to ensure Kite has compliant and effective environmental, health, safety and security programs.                         

Requirements:

•    BS degree in engineering or related field or equivalent experience required.

•    At least 8+ years of facility infrastructure & operations management for clinical GMP production in biotech/biopharma industry, preferably Tcell manufacture.

•    Demonstrated ability to work and collaborate in cross functional teams, research, development, manufacturing in a fast pace, dynamic team setting.  

•    Strong interpersonal, verbal and written communication skills are essential.

•    Advanced degree such as an MBA or PhD would be an advantage

•    High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.

•    Ability to adapt in a constantly evolving environment

•    Self-motivated with a strong sense of ownership in areas of responsibility