Director, Sterility Assurance

职位描述

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 Director for Sterility Assurance role. This is a critical leadership role responsible for overseeing all microbiological and virological control aspects of cell and gene therapy product manufacturing. This role ensures the safety, quality, and compliance of our products and processes through the development, implementation, and management of robust testing programs, risk assessments, and quality systems. The Director will provide technical expertise and strategic direction in microbiology and virology.

Job Responsibilities

Sterility Assurance Programs:

• Develop, implement, and manage comprehensive microbiology and virology programs, including environmental monitoring, incoming material testing, in-process testing, lot release testing, and stability testing.

• Serves as primary point of contact and decision maker for internal policies, procedures, and strategy documents governing Sterility Assurance and Contamination Control related topics.

• Support in knowledge advancement beyond the Quality organization to build, maintain, and develop capabilities across the Kite network for the Sterility Assurance space. Development of knowledge-based programs to advance company education and training programs. Provide mentoring leadership to stakeholder SMEs to build capability for new and existing sites or where gaps in technical expertise have been identified.

• Sponsor and oversee activities focused on driving process improvements and harmonization projects across the Kite network for Sterility Assurance and Contamination Control.

• Serve as the SME leadership role for topics associated with Sterility Assurance and Contamination Control across the network, representing on network teams and other appropriate governance forums.

• Provide technical support to during new process design and facility start-up activities to ensure Sterility Assurance programs and product requirements are supported at the sites.

• Engage in providing support during regulatory submissions and on-site inspections. Define and execute the process for managing observations and commitments related to Sterility Assurance for the Kite Network.

GMP Compliance and Quality Control:

• Ensure all sterility assurance testing activities comply with current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines (e.g., FDA, EMA).

• Provide guidance on developing and validating sterility assurance test methods.

• Provide technical support for investigations associated with Sterility Assurance and Contamination control to help identify root cause and implement appropriate corrective actions. Share best practices/learnings/CAPAs across the Kite network.

Cross-Functional Collaboration:

• Provide technical expertise in microbiology and virology to cross-functional teams, including Manufacturing, Quality Assurance, Process Development, and Regulatory Affairs.

• Participate in the development of manufacturing processes, ensuring microbiological and virological safety.

• Interact with regulatory agencies and participate sterility assurance expertise during inspections.

• Stay current with the latest advancements in microbiology, virology, and cell and gene therapy.

Basic Qualifications:

• PhD in Microbiology, Virology, or a related scientific discipline with 8+ years of experience in a microbiology/virology role within the pharmaceutical or biotechnology industry, with a focus on sterile manufacturing and advanced therapies OR

• Master’s degree in Microbiology, Virology, or a related scientific discipline with 10+ years of experience in a microbiology/virology role within the pharmaceutical or biotechnology industry, with a focus on sterile manufacturing and advanced therapies OR

• Bachelor’s degree in Microbiology, Virology, or a related scientific discipline with 12+ years of experience in a microbiology/virology role within the pharmaceutical or biotechnology industry, with a focus on sterile manufacturing and advanced therapies OR

• Associate’s degree in Microbiology, Virology, or a related scientific discipline with 14+ years of experience in a microbiology/virology role within the pharmaceutical or biotechnology industry, with a focus on sterile manufacturing and advanced therapies OR

• High School Degree with 16+ years of experience in a microbiology/virology role within the pharmaceutical or biotechnology industry, with a focus on sterile manufacturing and advanced therapies.

Preferred Qualifications:

• Ph.D. in Microbiology, Virology, or a related scientific discipline.

• 10 years of experience in a microbiology/virology role within the pharmaceutical or biotechnology industry, with a focus on sterile manufacturing and advanced therapies.

• Experience with cell and gene therapy manufacturing processes and associated regulatory requirements.

• Ability to effectively collaborate with and influence stakeholders at all levels of the organization.

• Extensive knowledge of cGMP regulations, FDA/EMA guidelines, and industry best practices related to microbiological and virological control in cell and gene therapy manufacturing.

• Strong expertise in sterility testing methodologies, including cell-based assays, molecular techniques, and rapid microbial methods.

• In-depth understanding of viral vectors, viral safety testing, and adventitious agent testing.

• Proven experience in developing and validating microbiological and virological test methods.

• Excellent leadership, communication, and interpersonal skills.

• Strong problem-solving, analytical, and risk assessment skills.

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 @KitePharma on Twitter at www.twitter.com/kitepharma.

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