Manufacturing Engineer II, Viral Vector Upstream

Santa Monica, CA

About the position

Kite is seeking a Manufacturing Engineer to support Viral Vector Clinical Operations at the Santa Monica facility in Southern California. We are seeking motivated, team-oriented candidates to join a fast-paced team of scientists and engineers to conduct operations related to viral vector production. 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

• Work in a team to support operations for clinical viral vector production at scale.
• Ensure safety and compliance as primary objectives of manufacturing operations.
• Plan, execute and oversee safe, compliant and efficient operation of area processes.
• Responsible for day to day planning and execution of all upstream production operations.
• Maintain equipment in a dynamic and fast-paced team environment.
• Perform upstream unit operations and operate related equipment such as Vial thaw, shake flask expansion, Wave bioreactor, single use production bioreactor, transfection, harvest depth filtration, and media preparation.
• Cross train with downstream operations for column chromatography, sterile filtration, UFDF, and buffer preparation.
• Perform routine maintenance of auxiliary equipment including pH/conductivity meters, filter integrity testers, autoclave, peristaltic pumps, tubing welders and analytical equipment.
• Perform aseptic operations in a Biological Safety Cabinet.
• Create and revise SOPs to support CAPAs, capital projects, and continuous improvement objectives.
• Document deviations, incidents, and safety concerns, and maintain cleanliness and inspection readiness.
• Set up and operate equipment in a ISO-7/ISO-5 clean room environment.
• Interact with scientists, engineers, production staff and operational lead.
• Ensure work is performed in accordance with quality standards and SOPs.
• Support deviation investigations, corrective action implementation and change management initiation.
• Represent the department as an SME on cross-functional teams.
• Perform troubleshooting as necessary and take initiative in resolving issues.

Requirements

• Masters 2+ degree OR Bachelors degree and 4+ years of relevant industry experience OR AA degree and 5+ years of relevant industry experience OR HS degree and 6+ years of relevant industry experience.

Nice-to-haves

• Prior experience in a cGMP-related industry, within Biopharmaceutical industry.
• Aseptic processing experience.
• Experience with upstream unit operations and related equipment.
• Previous biotechnology experience in viral vector production or downstream manufacturing of monoclonal antibodies.
• Knowledge of Current Good Manufacturing Practices (cGMPs).
• Experience initiating, owning and closing out deviations, change control, CAPA’s and safety improvement projects.
• Experience creating and/or revising SOPs to support projects or continuous improvement objectives.
• Background or understanding of Lean concepts (5S, KanBan).
• Background in disposable technology and multi-product facility requirements.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives.
• Paid time off.