Senior Manufacturing Associate

Kite Pharma Job Opportunity

We're here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

Knowledge: Demonstrates good verbal, written, and interpersonal communication skills. Working knowledge of Good Manufacturing Practices (GMPs) Works on non-routine to somewhat complex problems, requiring evaluation of multiple factors before taking action.

Specific Job Responsibilities:

• Work as part of a team to execute and lead manufacturing processes on the floor in close collaboration Manufacturing Science and Technology (MSAT), Facilities and Engineering (F&E) and Quality departments.
• Rigorously follow batch records, standard operating procedures (SOPs) and Current Good Manufacturing Practice (cGMP) regulations to ensure manufacturing operations are safe and compliant.
• Ensure right-the-first-time performance of all process steps specific to the phase or stage of operation, as well as help drive the safety-first culture at Kite Oceanside.
• Perform and manage electronic inventory transactions utilizing Manufacturing Execution Systems (MES) and Enterprise Business system (EBS) and weighing of raw materials and cycle count of raw materials.
• Perform, troubleshoot and manage moderately complex issues during cell culture, media formulation and filling unit operations for the manufacture of viral vector products in a cGMP environment using proper aseptic technique, proper laboratory etiquette, Good Documentation Practices (GDP), and sound scientific methods.
• Maintain mammalian cell culture in flasks, CellSTACK chambers and single use bioreactor systems.
• Review and sign off batch records for completeness, accuracy, and compliance.
• Participate in and manage operational excellence initiatives such as 5S, Kaizen, lean manufacturing and continuous improvement.
• Development of SOPs, Manufacturing Production Record (MPRs), and other process documents including minor deviations and Corrective Action and Preventive Action (CAPAs) as needed.
• Act at a delegate for supervisor and managers during cross functional team meetings.
• Manage and write shift notes for all unit operations.
• Lead operational tier huddles as needed.
• Manage and act as back-up qualified trainer for all unit operations.
• Act as a mentor to junior staff with limited task management responsibility.
• Ability to work effectively in an inclusive, cross-functional, team-based environment.
• Able to work off shift hours and weekend.
• Additional duties as assigned.

Basic Qualifications:

• BS and 4+ years of experience, or MS and 2+ years of experience, or, HS diploma, a Certificate to FETAC level 6 (GSL), and minimum 6 years of relevant experience.
• Cleanroom experience is a must; must be hands-on and comfortable working on the manufacturing floor
• Upstream cell culture experience is required
• Prior experience in a cGMP related industry is a MUST, within Biopharmaceutical or Pharmaceutical industry preferred.

Preferred Qualifications

BS and 8+ years of experience

MS and 6+ years of experience

The salary range for this position is: $92,820.00 - $120,120.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.