Sr Manufacturing Tech

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

Key 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 buffer preparation, purification and filling unit operations for the manufacture of viral vector products in a cGMP environment.
• Manage and implement tasks related to formulation of solutions along with filter integrity testing.
• Execution of downstream purification processes
• Experience escalating floor issues for triage while communicating out status updates and follow ups.
• Review and sign off in-process cGMP documentation 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.
• Excellent communication skills
• Ability to collaborate across all levels
• Ability to work effectively in an inclusive, cross-functional, team-based environment.
• Able to work off shift hours and weekend.
• Additional duties as assigned. These duties may be delegated to designated deputies of a satisfactory qualification level as needed.

Basic Qualifications:

• Master’s Degree and at least 2 years of experience in manufacturing, engineering in a biotech/pharma industry OR
• Bachelor’s Degree and at least 4 years of experience in manufacturing, engineering in a biotech/pharma industry OR
• Associate’s Degree and at least 5 years of experience in manufacturing, engineering in a biotech/pharma industry OR
• High School Degree and at least 6 years’ experience in manufacturing, engineering in a biotech/pharma industry

Preferred Qualifications:

• At least 6 years of experience with bachelor’s degree in biology or related scientific discipline, or equivalent combination of experience and education.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Prior experience with biopharmaceutical, cell or gene therapy manufacturing across Downstream and filling operations.
• Knowledge and experience with single use systems including chromatography, UFDF, and single use mixers.
• Experience with automation platforms and electronic batch records.
• Knowledge of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's) a plus
• Excellent skills in Microsoft Word, Excel and data analysis
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Excellent interpersonal, verbal and written communication skills
• Willingness to think outside of the box as well as comfortable in an exciting and constantly evolving environment.
• Ability to lift 40 lbs. repeatedly and stand for hours at time.
• Able to work off shift hours and weekends, as well as provide the on-call support as required.
• Ability to work effectively in an inclusive, cross-functional, team-based environment.
• Able to work off shift hours and weekend, as well as provide on-call support as needed.

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