Sr Manufacturing Tech

Key Responsibilities

• Work as part of a team to execute and lead manufacturing processes on the floor in close collaboration with MSAT, Facilities and Engineering (F&E) and Quality departments.
• Rigorously follow batch records, SOPs and 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 and help drive the safety-first culture at Kite Oceanside.
• Perform and manage electronic inventory transactions utilizing MES and EBS, weighing of raw materials and cycle count of raw materials.
• Perform, troubleshoot and manage moderately complex issues during buffer preparation, purification and filling unit operations for the manufacture of viral vector products in a cGMP environment.
• Manage and implement tasks related to formulation of solutions along with filter integrity testing.
• Execution of downstream purification processes.
• Escalate floor issues for triage while communicating status updates and follow ups.
• Review and sign off in-process cGMP documentation for completeness, accuracy, and compliance.
• Participate in and manage operational excellence initiatives such as 5S, Kaizen, lean manufacturing and continuous improvement.
• Development of SOPs, Manufacturing Production Records (MPRs), and other process documents including minor deviations and CAPAs as needed.
• Act as a delegate for supervisor and managers during cross functional team meetings.
• Manage and write shift notes for all unit operations.
• Lead operational tier huddles as needed.
• Manage and act as back-up qualified trainer for all unit operations.
• Act as a mentor to junior staff with limited task management responsibility.

Basic Qualifications

• Master's Degree and at least 2 years of experience in manufacturing, engineering in a biotech/pharma industry OR
• Bachelor's Degree and at least 4 years of experience in manufacturing, engineering in a biotech/pharma industry OR
• Associate's Degree and at least 5 years of experience in manufacturing, engineering in a biotech/pharma industry OR
• High School Degree and at least 6 years' experience in manufacturing, engineering in a biotech/pharma industry

Preferred Qualifications

• At least 6 years of experience with bachelor's degree in biology or related scientific discipline, or equivalent combination of experience and education.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Prior experience with biopharmaceutical, cell or gene therapy manufacturing across Downstream and filling operations.
• Knowledge and experience with single use systems including chromatography, UFDF, and single use mixers.
• Experience with automation platforms and electronic batch records.
• Knowledge of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's) a plus.
• 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 an exciting and constantly evolving environment.
• Ability to lift 40 lbs. repeatedly and stand for hours at time.
• Able to work off shift hours and weekends, as well as provide the on-call support as required.
• Ability to work effectively in an inclusive, cross-functional, team-based environment.