Manufacturing Technician
12-month contract
Oceanside, CA
Pay: $21-31.77/hr

Must Haves:

• Bachelor’s Degree

• AA Degree with 2+ years of experience in manufacturing, quality or engineering in a biotech/pharma industry 

• High School diploma with 3+ years of experience in manufacturing, quality or engineering in a biotech/pharma industry

Preferred: 

• 0+ years of experience with Bachelor's degree in biology or related scientific discipline, or equivalent combination of experience and education
• Prior experience with biopharmaceutical, cell or gene therapy manufacturing is a plus
• Knowledge of the Current Good Manufacturing Practices (cGMP's) desired
• Excellent skills in Microsoft Word, Excel and data analysis
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Excellent interpersonal, verbal and written communication skills
• Willingness to think outside of the box as well as comfortable in a fast-paced and constantly evolving environment
• Ability to lift 40 lbs repeatedly and stand for hours at time
• Able to work off shift hours and weekend

Responsibilities:
We are seeking a highly motivated Manufacturing Technician to support our Viral Vector manufacturing facility in Oceanside, CA. Under minimal supervision, in this role you will be accountable for and focused on front line manufacturing of viral vectors. 

Works on basic assignments following established Standard Operating Procedures (SOPs), Master Batch Records and current Good Manufacturing Practices (cGMPs). Performs routine tasks associated with aseptic processing, dispensing, compaction, granulation, milling and coating. Reports to Team Lead on a regular basis on line performance and report any issues that need to be resolved. Performs basic troubleshooting of issues and escalates when required. Organizes routine tasks in an effective manner. Prepares equipment and components for sterilization. Operates processing equipment including autoclaves, ovens, vial washers, and dehydrogenation tunnel. Cleans (manually and clean-in-place), assembles and disassembles equipment for production. Performs clean-in-place and sterilization-in-place of tanks. Performs annealing and sterile filtrations of products. Operates vial capper, unloads product from lyophilizes, and packs off unloaded vials from lyophilizes and liquid fill line. Performs Basic Oracle and MES (Manufacturing Execution System) transactions. Performs data calculations. Cleans manufacturing areas, including walls, ceilings and floors. Accurately completes required documentation of events and tasks related to assigned work, including logbooks, batch records, etc. Reports variance or deviation from standard procedures to department management. Prepares coating solution.

Responsibilities (include, but are not limited to):

• Execute manufacturing processes on the floor under supervision, while rigorously following batch records, standard operating procedures (SOPs), and Current Good Manufacturing Practice (cGMP) regulations to ensure manufacturing operations are safe and compliant.
• Ensure right-the-first-time performance of all process steps specific to the phase or stage of operation, as well as help drive the safety-first culture at Kite Oceanside.
• Work as part of a team to execute Good Manufacturing Practice (GMP) runs in close collaboration with, Manufacturing Science and Technology (MSAT), Facilities and Engineering (F&E) and Quality departments.
• Under supervision, perform weighing of raw materials, as well as electronic inventory transactions utilizing Manufacturing Execution Systems (MES) and Enterprise Business system (EBS).
• Under supervision, perform cell culture and filling unit operations for the manufacturing of viral vector products in a cGMP environment using proper aseptic technique, proper laboratory etiquette, Good Documentation Practices (GDP), and sound scientific methods.
• Prepare and use single use systems to support solution formulation and filter integrity testing.
• Maintain mammalian cell culture in flasks, CellSTACK chambers and single use bioreactor systems. 
• Assist with transfection of cells and harvest of viral vectors.
• Assist with manual and/or automated fill of harvested viral vector material. 
• Escalate processing and equipment issues as needed.
• Assist with revisions of SOPs, Manufacturing Production Record (MPRs), and other controlled documents.
• Assist in the review of in-process cGMP documentation for completeness, accuracy, and compliance.
• Ability to work effectively in an inclusive, cross-functional, team-based environment.
• Able to work off shift hours and weekend.
• Additional duties as assigned.