Associate Director, Viral Vector Downstream Manufacturing

Kite Pharma; Oceanside (CA); On-site; USD 165,000 - 215,000; Full time

Job summary

An innovative firm dedicated to curing cancer is seeking an Associate Director for Downstream Manufacturing Operations. This role involves leading a dynamic team responsible for the purification and packaging of viral vectors, ensuring compliance with GMP standards. The ideal candidate will have extensive experience in pharmaceutical manufacturing and a strong background in bioprocess management. Join a mission-driven organization that values leadership, teamwork, and a commitment to operational excellence. This is a unique opportunity to contribute to groundbreaking cancer therapies while fostering a culture of safety and efficiency.

Qualifications

• Experience in pharmaceutical manufacturing with a focus on bioprocess management.
• Strong knowledge of quality systems, validation, and regulatory guidelines.

Responsibilities

• Lead the downstream manufacturing team for vector production.
• Manage operations ensuring safety, quality, and efficiency.
• Identify process improvements to enhance yield and reduce costs.

Skills

Pharmaceutical Manufacturing

Bioprocess Management

Cell Purification

Regulatory Compliance

Process Improvement

Troubleshooting

Team Leadership

Education

Ph.D. in relevant field

MS/MA in relevant field

BS/BA in relevant field

High School Diploma

Tools

Single-Use Technology

DCS Systems

Electronic Batch Records

Job description

Associate Director, Viral Vector Downstream Manufacturing

Join to apply for the Associate Director, Viral Vector Downstream Manufacturing role at Kite Pharma.

We’re dedicated to curing cancer by developing innovative treatments. Our scientific breakthroughs include personalized CAR T-cell therapies that have transformed cancer treatment, and we are committed to making further advances.

Join Kite to help shape the future of cancer therapies. We believe in strong leadership and fostering an inclusive environment where employees can grow and succeed. Become part of our mission to create more tomorrows.

Job Description

Role and Responsibilities:

Kite Pharma, a Gilead Sciences Company, seeks an experienced Associate Director of Downstream Manufacturing Operations at our Oceanside biologics facility in Southern California. We are looking for motivated, team-oriented leaders with expertise in manufacturing vectors, large molecules, and vaccines. Reporting to the Director of Manufacturing, you will lead the purification, fill finish, and packaging manufacturing teams.

The Associate Director will oversee GMP manufacturing activities related to buffer preparation, purification, fill finish, and packaging. The role requires building and optimizing teams, coordinating projects, and developing team capabilities.

• Lead the downstream manufacturing team responsible for buffer prep, cell purification, and fill & finish/packaging of vector production.
• Provide strategic leadership, staff development, coaching, and performance reviews.
• Manage operations groups including Production and cGMP Cleaning, ensuring safety, quality, and efficiency.
• Plan and implement activities for campaign readiness, NPI, and changeover operations to meet production schedules.
• Identify process improvements to increase yield, capacity, efficiency, reduce costs, and ensure safety and compliance.
• Establish and evaluate performance metrics.
• Collaborate with Process Development, Quality, Validation, Engineering, Maintenance, Supply Chain, and other teams to align operations.
• Oversee deviations, CAPAs, incidents, and change management within Manufacturing.
• Participate in cross-functional projects, providing guidance and insights.
• Identify risks and develop mitigation plans.
• Ensure safety and compliance, fostering a culture of operational excellence.
• Support regulatory audits and inspections.

This is an exempt position requiring weekend and off-hours coverage.

Basic Requirements:

• Ph.D. with 2+ years in pharmaceutical manufacturing OR
• MS/MA with 8+ years in pharmaceutical manufacturing OR
• BS/BA with 10+ years in pharmaceutical manufacturing OR
• High School Diploma with 14+ years in pharmaceutical manufacturing.

Preferred Requirements:

• 10+ years in bioprocess management in cGMP environments.
• Experience in cell banking, purification, fill/finish, and packaging.
• Ability to influence cross-functionally with senior leaders.
• Strong knowledge of quality systems, validation, and regulatory guidelines.
• Experience with Single-Use Technology, DCS systems, and automated equipment.
• Experience with clinical and commercial production.
• Familiarity with Electronic Batch Records.
• Background in disposable technology and multi-product facilities.
• Strong troubleshooting, problem-solving, and critical thinking skills.
• Self-motivated with flexibility to work off-hours and weekends.

The salary range is $165,495 - $214,170, with potential bonuses, stock incentives, benefits, and paid time off. For more info, visit Gilead Benefits.

Kite Pharma focuses on innovative cancer immunotherapies like CAR and TCR therapies, based in Santa Monica, CA. For more, visit Kite Pharma.

Gilead is committed to diversity and equal employment opportunity, providing accommodations for applicants as needed.