Associate Director, Viral Vector Downstream Manufacturing

Scorpion Therapeutics; United States; Remote; USD 165,000 - 215,000; Full time

Job summary

A leading biopharmaceutical company is seeking an experienced Associate Director of Downstream Manufacturing Operations to oversee purification and packaging teams at their Oceanside facility. This role involves strategic leadership, team development, and ensuring compliance with GMP standards, contributing to innovative cancer therapies.

Benefits

Potential bonuses

Stock incentives

Paid time off

Comprehensive health plans

Qualifications

• Experience in pharmaceutical manufacturing required.
• Leadership experience in a cGMP environment preferred.
• Strong troubleshooting skills and adaptability to change.

Responsibilities

• Lead the Downstream Manufacturing team for vector production.
• Manage GMP manufacturing activities and ensure compliance.
• Implement process improvements to enhance efficiency.

Skills

Leadership

Problem-solving

Team building

Process improvement

Safety compliance

Education

Ph.D. in relevant field

MS/MA in relevant field

BS/BA in relevant field

High School Diploma

Tools

Single-Use Technology

DCS

Electronic Batch Records

Job description

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We’re here for one reason and one reason only – to cure cancer.

Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

People Leadership

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

Role and Responsibilities:

Kite Pharma, a Gilead Sciences Company, has an opportunity for an experienced Associate Director of Downstream Manufacturing Operations at our Oceanside biologics facility in Southern California. We are seeking motivated, team-oriented leaders with expertise in manufacturing of 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 of Downstream Manufacturing will oversee GMP manufacturing activities related to buffer preparation, purification, fill finish, and packaging. We seek a motivated leader with experience in building teams and optimizing operations. The role may include serving as a project lead or team representative on cross-functional projects. You will be responsible for direct reports and developing team capabilities.

Responsibilities include:

• Lead the Kite Vector Downstream Manufacturing team responsible for buffer prep, cell purification, and fill & finish/packaging of vector production
• Provide strategic and technical leadership, training, coaching, staff development, and performance reviews
• Manage Downstream Manufacturing operations groups including Production and cGMP Cleaning
• Plan and execute activities related to campaign or production readiness, new product introduction, and changeover operations
• Implement process improvements to increase yield, capacity, efficiency, reduce costs, and ensure safety and compliance
• Define success metrics and evaluate performance
• Partner with various departments to ensure alignment and meet timelines
• Oversee completion of deviations, CAPAs, incidents, and change management
• Represent the department in cross-functional projects, providing guidance and insights
• Identify risks and develop prevention plans
• Lead safety and compliance initiatives, 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
• MS/MA with 8+ years in pharmaceutical manufacturing
• BS/BA with 10+ years in pharmaceutical manufacturing
• High School Diploma with 14+ years in pharmaceutical manufacturing

Preferred Requirements:

• 10+ years bio manufacturing management experience in cGMP environment
• Experience in cell banking, purification, fill/finish, packaging
• Influence with senior leaders
• Knowledge of quality systems, validation, regulations, controls
• Experience with Single-Use Technology, DCS, automated equipment
• Experience with clinical and commercial manufacturing
• Experience with Electronic Batch Records
• Background in disposable technology and multi-product facilities
• Positive attitude, quick learner
• Adherence to safety and compliance standards
• Strong troubleshooting and problem-solving skills
• Self-motivated, adaptable to change
• Willing to work off hours and weekends as needed

Salary and Benefits

The salary range is: $165,495 - $214,170. Compensation varies based on experience, qualifications, and location. Benefits include potential bonuses, stock incentives, paid time off, and comprehensive health plans. More info at Gilead Benefits Information.

Company Overview

Kite is a biopharmaceutical company developing cancer immunotherapies, including CAR and TCR therapies. Based in Santa Monica, CA. Visit www.kitepharma.com.

Equal Employment Opportunity

Gilead is committed to diversity and equal opportunity employment. Discrimination based on race, gender, age, disability, or other protected categories is prohibited. Reasonable accommodations available. Contact [e-mail].

Workplace Environment

We promote a respectful, inclusive environment free from harassment. Embrace diversity of thought and background.

For Current Employees

Apply via the Internal Career Opportunities portal in Workday.