Assoc Director, Quality Control

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

Everyone at Kite is grounded by one common goal curing cancer. Every single day we seek to establish adirectline between thatpurposeand our day-to-day us in our mission!

We are seeking a highly motivatedindividualto join us as an Associate Director to lead Quality ControlAnalyticalTechServicesgroup reporting to the Senior Director Quality Control in Frederick this role you will lead a group and work closely with the Senior Director and other Associate Directors onsupportingcommercial operations in CAR-T technology.

You will work oncomplexprojectsinvolvingqPCR/ddPCR Flow cytometry and cell-based bioassaysand leadefforts in automation development foranalyticalassays. You will havecross-functionalinteractionwith personnel from other groups such as Quality AssuranceAnalyticalDevelopment Manufacturing MaterialManagement(MM) andCorporateteams.

PositionResponsibilities(include but not limited to):

• Provide technicalsupport process trending and procedural updates

• Lead method validation and method transferssupportcontinuous improvement tosupportmethod/product/invalid trending and to investigate laboratory/assay related findings.

• Lead andsupportmethod development validations and transfers

• Supportlaboratory investigations deviations CAPAschangecontrol asneeded

• Assist in investigation identify root cause for critical deviations anddetermineCAPA for QC asneeded

• Establish dataanalyticsto serve as metrics for monitoring trends in methods products and invalids

• Supportincoming tech transfers from AD/PD asneeded

• Author technical reports and protocols insupportof cGMP activities

• Supervise train andmentorjunior staff

• Createand/or revise procedures SOPs and test methods asneeded

• Supportequipment and software lifecyle process

• LIMS development and integration

• Provide technical expertise for AD/PD QA Regulatory Manufacturing and Supply Chain asneeded

• Supportand participate inspection readiness plans and participate during compliance audits (internal and external) and regulatory inspections.

• Follow technology changes recommends new technologies advises on technology purchases and implementation if appropriate.

• Additional duties as assigned.

Basic Qualifications:

• Advanced scientific degree (i.e. MD PharmD PhD) and 2years experience inbiologics/cell-gene therapy in QCAnalyticalAnalyticalDevelopmentenvironmentOR

• Masters Degreeand8years experience inbiologics/cell-gene therapy in QCAnalyticalAnalyticalDevelopmentenvironmentOR

• Bachelors Degreeand10years experience inbiologics/cell-gene therapy in QCAnalyticalAnalyticalDevelopmentenvironmentOR

• High School Degree and 14years experience inbiologics/cell-gene therapy in QCAnalyticalAnalyticalDevelopmentenvironment

Preferred Qualifications:

• Experience supervising/managinganalyticallabs within the biotechnology or pharmaceutical industry

• Well versed and experienced in bioanalytical methods working under GMP conditions.

• Deep experience in applying GMP in QC lab in conformance to US EU and ROW standards.

• Experience in conducting investigations writing deviations implementing CAPA and initiatingchangecontrols.

• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) Quality Control GMPs GLP

• Ability to effectively negotiate anddevelopcollaborationwithin teams and amongstindividuals.

• Demonstrated ability tocreateand maintain highly functioning teams.

• Excellentinterpersonal verbal and writtencommunicationsskills which are essential in thiscollaborativeworkenvironment

• Comfortable in a fast-pace small companyenvironmentwith minimal direction and able to adjust workload based on changing priorities.

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.

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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.