Associate Director, Process Development

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 T-cell 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

Key Responsibilities:

• Work with key stakeholders to support the life-cycle management activities including developing efficient business processes for process characterization and development of integrated control strategies.

• Provide guidance to team members to enable efficient and timely execution of life-cycle management activities.

• Act as an SME for design of experiments execution of studies under protocol appropriate use of statistical approaches implementation of QbD principles authoring of reports / regulatory documents response to questions from regulatory agencies process data analysis & trending using JMP and GMP manufacturing support.

• Review technical documentation technical SOPs manufacturing batch records technical reports and summary reports.

• Support equipment qualification risk assessment process characterization parameter classification TT and process validation activities for commercial manufacturing.

• Support and lead AI initiatives for process development and characterization

Basic Qualifications:

• PhD Degree in Biochemical Engineering Chemical Engineering Biomedical Engineering Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 5 years of experience or

• MS Degree in Biochemical Engineering Chemical Engineering Biomedical Engineering Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 8 years of experience or

• BS Degree in Biochemical Engineering Chemical Engineering Biomedical Engineering Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 10 years of experience or

Additional Qualifications:

• Candidates with prior experience and demonstrated capability within life-cycle management of cell and gene therapy products will be preferred.

• Candidates with prior leadership experience managing direct reports or cross-functional project teams will be preferred

• Practical knowledge of regulations and requirements pertaining to cGMP manufacturing for cell and gene therapy products.

• Practical knowledge of scientific and engineering principles related to bioprocessing including scale-up / scale-out approaches and process data analysis including machine learning models for process development

• Ability to think critically troubleshoot and problem solve in a timely manner.

• Excellent interpersonal verbal and written communication skills.

• Ability to work and collaborate in a fast paced dynamic cross-functional team setting across research development and manufacturing departments.

For additional benefits information visit:

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 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:

Kite Pharma 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 non-job related characteristics or other prohibited grounds specified in applicable federal state and local 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.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.