Director, Global Raw Materials & Reagents

United States - California - Santa MonicaQualityRegular

Descripción del trabajo

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

We are seeking a highly motivated individual to join us as Director, Global Raw Materials & Reagents , at our Santa Monica location. This position must excel in an environment that embraces teamwork, change, resolution making and flexibility. This role is expected to make a significant contribution to a multi-discipline team, must be self-motivated to take actions, and have excellent written and verbal communication skills.

Responsibilities:

Manages analytical, sample management and cell banking groups to ensure timely testing.
Manages method transfer qualification/validation of analytical methods related to raw materials.
Responsible for Cell Bank (Raji and Jurkat ) production and release for Kite QC Network
Ensures that GRM&R Systems and practices are developed and implemented in accordance with the requirements of cGMP.
Establishes and publishes Key Performance Indicators to track cGMP compliance for the GRM&R functions. Capture metric information for use in continuous improvement of areas of responsibility.
Direction of GRM&R functional groups to ensure timely testing. Oversight of laboratory training programs.

Collaborate and maintain routine interaction external contract testing laboratories.
Responsible for conducting laboratory investigations, OOS, OOT. Generation of CoAs for product release
Monitor the GMP systems currently in place to ensure compliance with documented policies. Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
Serves as a key business partner to senior stakeholders team focusing on strategic issues across multiple functions.
Provides stakeholders to direct reports and shapes a highly capable team through the attraction, training and development of the necessary skilled professionals to meet business needs.
Establish user requirements for purchase, qualification of Kite’s GRM&R analytical equipment. Work with internal and external resources to maintain equipment in an efficient state. Develop, revise and review SOPs, qualification/validation protocols and reports.

Quality Control, GMPs, bioanalytical method validation
Deep knowledge of GMP, SOPs and quality control processes
Deep knowledge of cell culture techniques

Equipment and utility IQ/OQ/PQ/PV
Responsible for effectively developing and managing the budget

Knowledge:

Ability to quickly establish credibility with diverse audiences and be perceived as a leader.
Excellent verbal, written, and interpersonal communication skills are required. Must possess excellent influencing skills.
In-depth understanding of business objectives and how they translate into quality priorities.
Works with senior management, develops plans and strategic direction for the team.
Collaborates cross-functionally with partners to ensure that GRM&R processes are aligned to the needs of Kite, ensuring compliance and alignment with business needs.
Requires experience and ability to manage a multi-disciplinary group.
Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.
Well versed in various analytical techniques for testing of biopharmaceuticals raw material and reagents.

Basic Qualifications:

Doctorate and 8+ years of Quality Control Biopharmaceutical, pharmaceutical or Biologic experience OR
Master’s and 10+ years of Quality Control Biopharmaceutical, pharmaceutical or Biologic experience OR
Bachelor’s and 12+ years of Quality Control Biopharmaceutical, pharmaceutical or Biologic experience

Preferred Qualifications:

10+ years of experience with an advanced science degree such as MS, PharmD, PhD is desirable.
Extensive knowledge and experience in quality control operations in highly regulated manufacturing environments is required.
Experience managing People Managers.
Experience in biotech, biologics or pharmaceuticals industry required.
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)

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

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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.