Manufacturing Engineer III

Kite Pharma•Santa Monica, CA

17h•Onsite

About The Position

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).

Requirements

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
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.
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
Highly analytical and continuous improvement minded

Nice To Haves

Willingness to think outside of the box and adapt best practices to our small, but growing environment
Background or understanding of Lean concepts (5S, KanBan)
Background in disposable technology and multi-product facility requirements
Experience in both downstream and upstream process development / manufacturing

Responsibilities

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.
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.