Manufacturing Engineer III- Viral Vector Clinical Operations

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Job Description

Kite is seeking a Manufacturing Engineer III to support Viral Vector Clinical Operations at the Santa Monica facility in Southern 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:

Masters degree in Biochemical Engineering Chemical Engineering Biotechnology Chemistry Biology or equivalent and 3 years of relevant industry experience

OR

Bachelors 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:

• Bachelors 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 CAPAs 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

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

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