Manufacturing Engineer III- Viral Vector Clinical Operations

Manufacturing Engineer III

Kite is seeking a Manufacturing Engineer III to support Viral Vector Clinical Operations at the Santa Monica facility in Southern California. This individual will help coordinate logistics and operations related to day-to-day activities of at-scale production of the viral vectors in the clinical GMP pilot facility. Join a team of manufacturing engineers supporting routine to complex assignments following established Standard Operating Procedures (SOPs), Master Batch Records and current Good Manufacturing Practices (cGMPs).

Responsibilities (include but not limited to):

• Work within a team of manufacturing engineers to support end to end operations for clinical viral vector production at pilot and bench scale with a primary focus on upstream production.
• Partner with EHS to promote positive safety culture and ensure facility and operations are maintained at the highest level of safety.
• Provide purposeful presence in the production suite to ensure compliant and efficient operation of area processes.
• Responsible for planning and execution of upstream production operations as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain equipment in a dynamic and fast-paced team environment.
• Coordinate with downstream engineers to develop training plan and team responsibility matrix.
• Perform upstream unit operations and operate related equipment such as vial thaw, shake flask, pooling operations within proper aseptic technique in a biosafety cabinet, and single use bioreactor units.
• Proficiency and routine maintenance of auxiliary equipment including but not limited to: cell counters, pH/conductivity meters, filter integrity testers, autoclave, peristaltic pumps, tubing welders and analytical equipment to support and monitor the process is required.
• Development of chromatography methods to enable column chromatography operations.
• Create and revise SOPs to support CAPAs, capital projects, and continuous improvement objectives.
• Good Documentation Practices (GDPs), timely and effective written and oral communication of deviations, incidents, and/or safety concerns, and all relevant housekeeping duties to ensure the work areas are kept to a high level of cleanliness and inspection readiness.
• Set up and operate equipment in a ISO-7/ISO-5 clean room environment and complete all required paperwork using GDPs in a timely and accurate manner.
• Interact with scientists, engineers, production staff and operations director.
• Ensures that work is performed in accordance with EHS, quality, and operational standards and SOPs.
• Support deviation investigations, corrective action implementation.
• In-depth knowledge of quality systems, validation principles, regulatory/ICH guidelines and multi-product controls preferred.
• Departmental representation as an SME (Subject Matter Expert) on cross-functional teams including Process Development, Quality Assurance and Control, Calibration, Maintenance, Validation, Supply Chain, and CMC/Regulatory teams is required.
• Perform troubleshooting as necessary and take initiative in resolving issues.
• Develop bill of materials and manage raw material planning and inventory for GMP and non GMP orders.
• Analyze data and provide recommendations on process improvements.

Basic Qualifications:

Master's degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent and 3+ years of relevant industry experience

OR

Bachelor's degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent and 5+ years of relevant industry experience

OR

HS diploma and 9+ years of relevant industry experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent

Preferred Qualifications:

• Bachelor's degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent and 5+ years of relevant industry experience
• Prior experience in a cGMP-related industry is required, within Biopharmaceutical industry
• Aseptic processing experience.
• Experience with upstream unit operations and related equipment listed in the Responsibilities Section.
• Previous biotechnology experience in viral vector production or upstream manufacturing of monoclonal antibodies in a clinical or commercial environment.
• Knowledge of Current Good Manufacturing Practices (cGMPs).
• Prior experience initiating, owning and closing out deviations, change control, CAPA's and safety improvement projects.
• Prior experience creating and revising SOPs to support projects or continuous improvement objectives.
• Willingness to think outside of the box and adapt best practices to our small, but growing environment
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• High energy level and a positive outlook coupled with the requisite willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
• Background or understanding of Lean concepts (5S, KanBan)
• Background in disposable technology and multi-product facility requirements
• Highly analytical and continuous improvement minded
• Experience in both downstream and upstream process development / manufacturing

The salary range for this position is: $115,260.00 - $149,160.00. 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.