Lab Ops Specialist II

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

• Perform QC sample receipt processing and distribution for testing and storage.

• Perform Apheresis accession inspection and assist QA with product returns.

• Maintain and operate equipment and instruments supporting sample processing.

• Work with internal resources to maintain the lab in an optimal state.

• Perform cryo sample disposition and shipment.

• Track inventory of lab supplies retain samples stability samples and test materials.

• Track and distribute samples according to stability protocols.

• Support on-the-job training for junior staff.

• Troubleshoot standard issues and identify deviations from standard processes.

• Own deviations CAPAs and change controls when necessary.

• Gather metric information for continuous improvement of areas of responsibility.

• Perform data entry and review.

• Support generation of Certificates of Analysis (CoAs) for product release.

• Assist in preparation of dossiers and data packages for interactions between Kite and regulatory agencies if needed.

• Develop revise and review SOPs work instructions forms sampling plans qualification/validation protocols and reports.

• Support investigations regarding out-of-specification (OOS) results out-of-trend (OOT) events and other unexpected laboratory events.

• Monitor GMP systems to ensure compliance with documented policies.

• Evaluate current operational processes and practices for efficiency and potential improvements.

• Work with LIMS administrators to incorporate new processes for sample management in LIMS.

• Assist with audits walkthroughs and inspections when necessary.

• Perform additional duties as assigned.

• Duties may be delegated to qualified deputies as needed.

Basic Qualifications

• BS degree in a scientifically oriented field and at least 2 years related work experience.

OR

• MS degree in a scientifically oriented field and at least 0 years related work experience.

OR

• AS/AA degree in a scientifically oriented field and at least and 4 years of experience in Quality Control/GMP environment

Preferred Qualifications

• Degree in biotechnology or related field with Quality Control experience.

• Working knowledge of GMP SOPs and quality control processes.

• Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211).

• Proficient in MS Word Excel PowerPoint and other applications.

• Ability to communicate and work independently with scientific/technical personnel.

• Strong written and verbal communication skills.

• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities.

• Experience with LabVantage LIMS.

• Flexibility to work variable schedules including weekends as business needs require.

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.