Director, Manufacturing

职位描述

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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.

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

The Director of Manufacturing, reporting to the Site Head, Viral Vector Operations, is responsible for leading, instructing and supporting managers, supervisors, and manufacturing associates in a complex viral vector commercial and clinical manufacturing environment. This includes developing staff technical capabilities, creating a culture of continuous improvement, operational efficiency, quality and safety.

The Director is responsible for leading a team to successfully manufacturing viral vectors, team development, and establishing a culture that achieves operational excellence. He/She must be able to collaborate with Facilities & Engineering Director, Supply Chain Director, MSAT (Manufacture Science & Technology) Sr. Director, and all other business partners to ensure reliable, expandable, and consistent vectors are produced for our T-Cell manufacturing facilities. The Director of Manufacturing must ensure compliance with Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices.

Responsibilities (include but are not limited to):

• Manufacturing of products which closely impact budget line of the department
• Lead manufacturing team with focus on operations with high success rate, low deviations, and that are “right the first time”
• Supervises and monitors performance of manufacturing manager and supervisor
• Coordinates with Supply Chain on the creation and revision of production schedule based on Capacity Review Management and Operations Council Process.
• Ensures cGMP training and readiness of Manufacturing Team for compliance audits and day to day compliance
• Ensures manufacturing areas, team, and equipment are current on all cGMP and regulatory specifications
• Assists in transfer of new technology and processes and supports operational readiness and safety
• Creates operational efficiencies related to materials, labor and overhead
• Resolves organizational targets and interprets company policies for the department
• Continuous improvements in all operation processes including safety elements
• Investigates and resolve problems, identifying root cause, and proposing process improvements through clear communication utilizing expertise coupled with OE tools,
• Create an environment where productivity and efficiency are achieved and recognized
• Establish operational strategy, goals and assignments
• Anticipate and address inspection issues that impact plant operations.
• Maintain a high level of compliance through effective monitoring and reporting of operational, key quality and safety metrics
• Ensure timely execution of deviations, CAPA’s, change control support and continuous improvement initiatives
• Manufacturing leader for inspection activities, observation commitments, submission and agency requests for products for assigned manufacturing plant
• Develop team’s technical capabilities for single use technologies, upstream and downstream manufacturing and fill/finish manufacturable activities.
• Provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews
• Collaborate with cross functional leaders to implement strategy and shared goals
• Communicate, collaborate and interact with Manufacturing Leadership Team and functional department heads
• Develop and administer budgets, schedules, and goals
• Independently determine approach and requirements to managing teams and executing operations with meaningful collaborations with peer leaders
• Other duties as assigned

Basic Qualifications:

• Doctorate and 8+ years of experience managing a cell culture and/or purification manufacturing team in the biotechnology or biologics industry OR
• Master’s and 10+ years of experience managing a cell culture and/or purification manufacturing team in the biotechnology or biologics industry OR
• Bachelor’s and 12+ years of experience managing a cell culture manufacturing and/or purification team in the biotechnology or biologics industry

Preferred Qualifications:

• Meaningful understanding of the business, science, engineering, and technology of biotechnology, processes, equipment and facilities
• Knowledgeable of the current regulations, Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's)
• Clinical (Pivotal-Phase II/III) and commercial cell culture and/or purification manufacturing experience highly preferred
• In depth knowledge of process operations related to upstream and downstream equipment
• Expert knowledge of electronic quality systems
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
• Willingness to think outside of the box and adapt best practices to our small, but growing environment
• Ability to adapt in a constantly evolving environment
• Always leading with safety area ownership utilizing 6 S and Gemba walks to establish a world class safety culture
• Self-motivated with a thorough sense of ownership in areas of responsibility
• Demonstrated ability to work side by side on the floor or operations environment to develop a team

Does this sound like you? If so, apply today!

The salary range for this position is: $187,000.00 - $242,000.00. 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 @KitePharma on Twitter at www.twitter.com/kitepharma.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.