Sr Manufacturing Engineer - Viral Vectors

职位描述

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?

Kite is seeking a Senior Manufacturing Engineer to manage Viral Vector Clinical Operations at the Santa Monica facility in Southern California. This Individual will manage logistics and operations related to day-to-day activities of the downstream large-scale production of the various viral vectors/platform in the clinical vector facility. Join a team of Downstream 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):
• Develop a team of manufacturing engineers to support downstream and formulation operations for clinical viral vector production at pilot and bench scale.
• Develop careers of direct reports and provide coaching and feedback
• 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 creating finite schedule planning and implementation of all Downstream 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 upstream Sr manufacturing engineer to develop training plan and team responsibility matrix.
• Perform downstream unit operations and operate related equipment such as:
• Harvest depth filtration, column chromatography, sterile filtration, and UFDF, and buffer preparation in small scale and pilot scale.
• Proficiency and routine maintenance of auxiliary equipment including but not limited to: pH/conductivity meters, filter integrity testers, autoclave, peristaltic pumps, tubing welders and analytical equipment to support and monitor the process
• Development of AKTA Unicorn methods to enable column chromatography operations.
• Perform operations in a Biological Safety Cabinet with proper aseptic technique.
• Create and revise SOPs to support CAPAs, capital projects, and continuous improvement goals.
• 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.
• Sets up and operates equipment in a ISO-7/ISO-5 clean room environment and completes all required paperwork using GDPs in a timely and accurate manner.
• Interacts 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
• 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.

Basic Qualifications:

• Master’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent and 6+ years of relevant industry experience or
• Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent and 8+ years of relevant industry experience or
• HS diploma and 10+ years of relevant industry experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent
• 2+ years in position as a leader, with 2 or more direct reports

Preferred Qualifications:

• Prior experience in a cGMP-related industry within Biopharmaceutical industry
• Aseptic processing experience.
• Experience with downstream unit operations and related equipment listed in the Responsibilities Section.
• Previous biotechnology experience in viral vector production or downstream 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/or revising SOPs to support projects or continuous improvement goals.
• 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
• Willingness to work 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
• Able to lift equipment up to 25 lbs.