Senior Process Engineer I, Viral Vector Process Design

$130,220 - $168,520/Yr

1110 Kite Pharma, Inc. - Santa Monica, CA

Full-time - Mid Level

Santa Monica, CA

About the position

Kite Pharma is seeking a highly motivated Senior Process Engineer I to join the viral vector process development team. This role is crucial for designing and characterizing viral vector processes to support GMP manufacturing for Kite's pipeline programs. The engineer will focus on process improvements, lead lab-based activities, and collaborate with various Technical Operations groups to ensure effective communication of study outcomes and program risks.

Responsibilities

• Design, implement and lead lab-based activities supporting process improvement studies and life cycle development.
• Support lab implementation and develop a best practices and proactive safety culture amongst PDe staff.
• Collaborate with Operations, Manufacturing, Autologous PDe, and MSAT teams to identify process improvement needs and develop a strategy encompassing feasibility evaluation through implementation for next generation platform processes.
• Design, implement and analyze process characterization studies in support of late phase programs.
• Provide hands-on training of viral vector unit operations to vPDe, MSAT and manufacturing staff.
• Become a subject matter expert of vector product and process platform historical data to propose process design improvements that can resolve program risks.
• Effectively communicate process data trends, characterization results and process improvements in both written and presentation format.

Requirements

• MS/MA Degree in Chemical/Biochemical Engineering, Biomedical Engineering, Biotechnology or a related discipline and 4+ years of pharmaceutical/biotech industry experience in manufacturing or process development.
• BS/BA Degree in Chemical/Biochemical Engineering, Biomedical Engineering, Biotechnology, or a related discipline with 6+ years of pharmaceutical/biotech industry experience in manufacturing or process development.
• High School Diploma with 11+ years of pharmaceutical/biotech industry experience in manufacturing or process development.

Nice-to-haves

• Practical expertise/knowledge of cGMP manufacturing for Biologics or Viral Vector or Gene and Cell therapy products.
• Exceptional written and oral communication skills to a scientific and quality-focused audience.
• Experience in managing multiple complex projects simultaneously through effective time management and with little oversight.
• Previous experience with process design and technology transfer is preferred.
• Knowledge of process validation and qualification is preferred.
• Thorough understanding of operating and performance parameters, as well as establishing parameter ranges.
• Previous experience with cell culture and aseptic process experience is preferred.
• Previous experience with downstream purification operations inclusive of depth filtration, ultrafiltration/diafiltration, chromatography, and sterile filtration preferred.
• Previous experience with final fill into bags or vials preferred.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives (eligibility may vary based on role).
• Paid time off.