Supervisor, cGMP Facility Cleaning

仕事内容

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

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.

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

We are seeking a highly motivated individual to join our organization as a supervisor for the cGMP Cleaning staff to support Kite’s Viral Vector facility in Oceanside, CA. The supervisor will provide 2nd shift cGMP cleaning oversight for our ISO Classrooms and Controlled Non-Classified Lab Areas.

SHIFT: Evening Shift, 4:00pm-12:30am

Responsibilities

• Oversee and perform cleaning operations under strict guidelines for Controlled cleanrooms and GMP laboratory environments.
• Continually monitor the cleanroom and laboratory cleaning procedures to ensure all cleanings are completed promptly and correctly.
• Maintains accurate and complete records. Review documentation and logbooks and ensure GMP compliance.
• Performs sterile and non-sterile stocking, staging and shifting (FIFO) of usable garments for multiple gowning rooms
• Maintains accurate and complete inventory of cleaning supplies ensuring supplies are never depleted
• Reviews and provides signatory signoff of documentation. Updates SOPs and FRMs as needed.
• Responsible for participating in continuous training: cGMP training, technical skills, safety, and performance improvement. Attends and completes all training assigned by Company SOPs, procedures, and policies
• Maintain training requirements for staff and administer training as needed for new or current staff.
• Participate in deviation investigations and identify root cause solutions.
• Perform other tasks/duties as assigned by stakeholders and support other Departments as needed
• Safety first mindset. Works in a safe and effective manner in accordance with all company, state and federal rules and regulations

Requirements

• Thorough understanding of cGMP facility and laboratory cleaning within a controlled environment including ceilings, walls, equipment, and floors.
• Physically capable to don and wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves (PPE are essential for the health and safety of employees)
• Have an excellent work ethic and demonstrate dependability and timeliness.
• Ability to read and follow strict Standard Operating Procedures
• Must be able to work off shift hours, holidays, and weekends as well as on-call rotation.
• Ability to manage a team and possess the skills to work in a self-guided manner
• Able to lift and/or move up to 40 pounds.
• Able to squat, bend, move, and/or reach for about 50% of shift
• Able to stand, walk, and/or move about for 50% of shift.

Basic Qualifications:

• Bachelor’s degree with 2+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience OR
• High School Degree with 4+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience

Preferred Qualifications:

• 4+ years of clean room sanitization experience or cGMP operational experience
• 4+ years of Supervisory Experience Ability to work in a clean room environment where Biohazardous wastes are handled and removed daily.
• Ability to lead a team across multiple shifts
• Work ethic and demonstrate dependability and timeliness
• Good interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Detail oriented, excellent Good Documentation Practices
• Comfortable in a passionate company environment with minimal direction and able to adjust workload based upon changing priorities