Senior Manufacturing Technician, Downstream

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Nov 25, 2020
Ref
R0016159
Required Education
Masters Degree/MBA
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

Kite is seeking a manufacturing specialist 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 purification and formulation. Join a team of Downstream Manufacturing Technicians 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 in a team to support downstream and formulation operations for clinical viral vector production at scale.
  • Safety and Compliance are the two primary objectives of manufacturing operations. Expected duties include the planning, execution and oversight of safe, compliant and efficient operation of area processes.
  • Responsible for day to day planning and execution 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.
  • Works in conjunction with other manufacturing technicians under the guidance of the team Lead.
  • 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 is required.
  • Perform aseptic operations in a Biological Safety Cabinet.
  • Create and revise SOPs to support CAPAs, capital projects, and continuous improvement objectives.
  • In-depth knowledge of quality systems, validation principles, regulatory/ICH guidelines and multi-product controls required.
  • 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 operational lead.
  • Ensures that work is performed in accordance with quality standards and SOPs.
  • May support deviation investigations, corrective action implementation and change management initiation.
  • 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 takes initiative in resolving issues.


Basic Qualifications:
  • Masters degree and 2+ years of relevant industry experience
  • Bachelors degree and 4+ years of relevant industry experience
  • HS diploma and 6+ years of relevant industry experience


Preferred Qualifications:
  • Prior experience in a cGMP-related industry is required, 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 objectives.
  • Background or understanding of Lean concepts (5S, KanBan)
  • Background in disposable technology and multi-product facility
  • Able to lift equipment up to 25 lbs.


Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

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 system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.