Senior Manager Material Development - Cell Therapy 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 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 highly motivated individual with Extractables & Leachables (E&L) knowledge and material evaluation experience to join our team as a Senior Manager to contribute toward the advancement of innovative Tcell therapy processes and technologies for cancer treatment at Kites Santa Monica CA facility. The Senior Manager will lead Kites cell therapy E&L program including endtoend E&L risk assessment testing lab management and regulatory filing support. In addition the Sr Manager will support chemicals/reagent material selection for Kites cell therapy pipeline products and new process technology development. The Sr Manager will influence the raw material decisions through technical assessment and lab studies write and/or review user requirements/specifications coordinate internal and external studies write technical reports/memos to provide rationales and approvals for engineering and process design changes to meet internal facility fit and regulatory requirements.

The Sr Manager will work closely with teams from Process Development Analytical Validation CMC and Regulatory Affairs to evaluate and monitor the endtoend E&L risk of raw materials used in Kite cell therapy manufacturing process. The Sr Manager is expected to follow industry trend on E&L regulatory requirements and apply to Kite E&L program management.

The Sr Manager will collaborate with crossfunctional teams to select chemicals/reagents to work with Kites next generation manufacturing equipment and platform and colead the of material evaluation projects from proofofconcept design and testing to implementation and training for the receiving site.

Responsibilities

• Lead Kite E&L program including the risk assessment of all materials used in viral vector and cell therapy manufacturing process. Monitor E&L regulatory requirement change and work closely with CMC and Regulatory Affairs team to support pipeline development and BLA filing.
• Collaborate external teams and internal teams within Process Development to influence the selection of chemicals and single use disposables design. Design internal studies to evaluate impact on material properties to process.
• Manage external E&L study design report writing and toxicology assessment report.
• Lead handson activities that support PD and technology development design iterations through the of laboratory studies drafting experimental procedures study designs and analytical sampling plans followed by interpretation and communication of results through presentations technical reports and feedback sessions with partners and multifunctional risk assessment teams
• Define user requirement and acceptance criteria of material compatibility to support critical product quality attributes
• Collaborate closely with site and global partners to define and develop material requirements and qualification strategy for singleuse disposables and new technologies
• Acquire a detailed understanding of cell therapy processes equipment and technologies including process operating parameters performance criteria control strategy and translation of said specifications into user requirements and functional requirements.
• Data analysis presentation and report writing of results conclusions and recommendations
• Collaboration and management of internal and external partners and vendors.
• Application of project management and/or project leadership skills
• Lead and develop user requirements based on process quality and fitness for use in a GMP manufacturing environment. Work with vendors suppliers and internal partners to translate Kite specific requirements into functional and design specifications
• Operationalize new process technology to ensure successful GMP manufacturing
• Handle technical work streams with crossfunctional stakeholders and external collaborators throughout entire project lifecycle from conception to implementation
• Define manage and communicate project timelines and risks
• Maintain handson understanding on cell therapy bioprocessing techniques
• Support onboarding and mentoring of new team members

Requirements

• PhD degree in Biochemical Engineering Chemical Engineering Biomedical Engineering Biochemistry Material Science or related discipline with 0 years of pharmaceutical / biotechnology process development industry experience or
• MS degree in Biochemical Engineering Chemical Engineering Biomedical Engineering Biochemistry Material Science or related discipline with 4 years of pharmaceutical / biotechnology process development industry experience or
• BS degree with 6 years of pharmaceutical / biotechnology process development industry experience or
• High School Diploma with 11 years of pharmaceutical / biotechnology process development industry experience

Preferred Qualifications

• Knowledge of pharmaceutical cGMP principles for biotechnology manufacturing aseptic processing cell therapy products and process development

• Knowledge of regulatory regulations and requirements for pharmaceutical materials and E&L.
• Handson cell culture techniques and efficiencies using bioreactors and other culturing modalities cell isolation methods and use of laboratory equipment and analytical tools
• Established cell culture and aseptic processing techniques in a BSC such as cell passaging sampling fluid handling media formulation reagent and vial management and cryopreservation
• Use of statistical design of experiments
• Mastery of scientific and engineering principles related to bioprocessing including scaleup / scaleout approaches hydrodynamics mass transfer and cell culture equipment design control and monitoring strategies
• Fundamental understanding of cell biology principles subpopulation types differentiation phenotype markers and metabolic pathways is a plus
• Basic knowledge of material science and material compatibility with cell culture is a plus

Additional Qualifications

• Welldeveloped computer skills ability to multitask and selforganize
• Practical project management skills
• Selfmotivated strong sense of responsibility and willingness to accept temporary responsibilities outside of initial job description
• Highly collaborative results oriented positive can do attitude with a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
• Comfortable in a fastpaced environment with minimal direction and ability to adjust workload based upon changing priorities

• Ability to deliver in a fast pace dynamic crossfunctional team environment across research development and manufacturing departments
• Ability to think critically and demonstrated troubleshooting and problemsolving skills
• Excellent interpersonal verbal and written communication skills
• Knowledge of data management tools and statistical process controls
• Ability to function efficiently and independently in a changing environment

Qualifications

• Degree in Chemical Engineering Bioengineering pharmaceutical sciences or related field and appropriate years of experience: Ph.D. with 0 years work experience OR MS with 4 years of relevant work experience OR BS with 6 years of relevant work experience
• Strong understanding of biologics drug substance downstream manufacturing processes i.e. conjugation purification operations bulk freeze/thaw.
• Experience supporting drug substance manufacturing operations technology transfer and/or development. Past history with commercial manufacturing and/or process validation is highly desirable.
• Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing
• General understanding of protein structure and modes of degradation under various processing conditions
• Excellent troubleshooting skills and ability to solve complex technical issues.
• Ability to effectively collaborate in a dynamic crossfunctional matrix environment.
• Excellent and effective verbal and written communication skills
• Experience working in agile global and multicultural teams

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 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 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:

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 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.

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

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.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.