Job Description

Knowledge:
• Demonstrates in-depth understanding and application of GMP principles, concepts, practices, and standards in the US and internationally.
• Demonstrates strong knowledge of aseptic processing, solid dose, and general pharmaceutical manufacturing.
• Demonstrates substantial knowledge of industry best practices and trends.
• Is comfortable interacting with regulatory agencies as needed and possesses the ability to represent Gilead in public forums.
• Is an experienced auditor and has demonstrated acumen in resolving challenging audit situations.
• Demonstrates excellent verbal, written, and interpersonal communication skills.

Specific education and experience requirements:
• 12+ years of relevant experience, and BS or related fields.
• MS, MD, PharmD, PhD or an advanced business degree such as an MBA is desirable.
• Broad experience across areas such as manufacturing and understanding of Parenteral, Aseptic, and API operations is a plus.
• Prior people management experience, including supervision of other managers, strongly preferred.
• Prior experience and deep knowledge of a cGMP-related industry is required, within Biopharmaceutical or Pharmaceutical industry preferred.

Specific job responsibilities:
• Directs activities within the Manufacturing Department to meet company goals including production schedules, environmental concerns, and safety issues.
• Responsible for delegating and ensuring completion of personnel management activities, including hiring, training, evaluating, and performance review.
• Coordinates maintenance of production equipment; interfaces with contract filling sites.
• Coordinates production flow from Process Development to Manufacturing.
• Ensures all regulatory requirements are met in the Manufacturing Department.
• Responsible for manufacturing of products, which directly impact budget line of the department.
• Supervises and monitors performance of Manufacturing Managers & Senior Managers.
• Coordinates with supply chain on the creation and revision of production schedules, based on sales and/or clinical requirements.
• Schedules product filling at off-site contracts.
• Ensures availability of required components at contractor sites.
• Ensures cGMP training of all Manufacturing employees.
• Ensures manufacturing areas and equipment meet all current GMP and all other regulatory specifications.
• Assists in transfer of new technology from Process Development to Manufacturing.
• Recommends and assists in development of practices and policies in manufacturing area.
• Creates cost reduction opportunities as related to materials, labor, or overhead.
• Determines organizational objectives and interprets company policies.
• Responsible for continuous improvement in all operation processes.

The salary range for this position is: $191,250.00 - $247,500.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow [redacted] on Twitter at www.twitter.com/kitepharma.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.