Director, Sterility Assurance
Director, Sterility Assurance
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$ 191250 - 247500
1 Vacancy
Job Description
Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR Tcell therapies have changed the paradigm. But were 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 inprocess 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 knowledgebased 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 startup activities to ensure Sterility Assurance programs and product requirements are supported at the sites.
Engage in providing support during regulatory submissions and onsite 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.
CrossFunctional Collaboration:
Provide technical expertise in microbiology and virology to crossfunctional 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 8years of experience in a microbiology/virology role within the pharmaceutical or biotechnology industry with a focus on sterile manufacturing and advanced therapies OR
Masters degree in Microbiology Virology or a related scientific discipline with 10years of experience in a microbiology/virology role within the pharmaceutical or biotechnology industry with a focus on sterile manufacturing and advanced therapies OR
Bachelors degree in Microbiology Virology or a related scientific discipline with 12years of experience in a microbiology/virology role within the pharmaceutical or biotechnology industry with a focus on sterile manufacturing and advanced therapies OR
Associates degree in Microbiology Virology or a related scientific discipline with 14years 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 cellbased assays molecular techniques and rapid microbial methods.
Indepth 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 problemsolving analytical and risk assessment skills.
For additional benefits information visit:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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 for assistance. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. Please apply via the Internal Career Opportunities portal in Workday.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid longterm 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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTFor Current Kite Pharma Employees and Contractors:
Required Experience:
Director
Employment Type
Full-Time
