For Current Kite Pharma Employees and Contractors:

　　Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

　　Job Description

　　Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.

　　Kite is seeking a highly motivated individual to join us as a QC Specialist in our new commercial cell therapy production center located in Frederick, MD. You will report into the Quality Control Microbiology Supervisor or Manager and provide Quality Control support of commercial manufacturing of final drug product. You will also perform technical oversight of Quality Control methods and programs for cell therapy products. Are you ready to help bring lifesaving therapies to cancer patients in need.

　　You will also be responsible for providing Quality Control support of commercial manufacturing of final drug product.

　　Shift Note: Wed-Sat - 3pm-2am

　　Responsibilities include (but are not limited to):

　　Conduct investigations regarding environmental monitoring (EM) action level excursions, and out of specifications (OOS) results.

　　Execute EM/UM sampling as well as Microbiological Testing such as: Media Growth Promotion Testing, Microorganisms ID, Sterility and Endotoxin Testing

　　Investigate and manage deviations related to microbiology procedures and cleanroom related activities. Determine corrective/preventative actions (CAPA) and drive implementation.

　　Assist in the generation of trend reports on environmental monitoring and product release data. Frequently update management on trends. Implement corrective action plans when necessary.

　　Assist in the transfer and provide technical oversight and training of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability).

　　Assist in the management of laboratory activities and provide technical direction to staff.

　　Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release.

　　Develop, revise and review SOPs, qualification/validation protocols and reports.

　　Support execution of protocol or study as needed.

　　Monitor the GMP systems currently in place to ensure compliance with documented policies.

　　Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate. Assist in the gathering of metric information for use in continuous improvement of areas of responsibility.

　　Support the QC Microbiology and Aseptic Techniques Training programs.

　　Additional duties as assigned.

　　These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

　　Basic Qualifications:

　　Master’s Degree and OR

　　Bachelor’s Degree and 2+ years’ experience in a biotech/biopharmaceutical setting OR

　　AA Degree and 4+ years’ experience in biotech/biopharmaceutical setting OR

　　High School Degree and 5+ years’ experience in biotech/biopharmaceutical setting

　　Preferred Qualifications:

　　Experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required.

　　Familiar in various microbiological techniques including rapid release methods, and environmental monitoring processes with reference to cell therapy product.

　　Familiar in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes is preferred.

　　Familiar with Environmental Monitoring requirements and tests (viable and non-viable),

　　Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals

　　Ability to gown for entry into Aseptic core and supporting areas.

　　Working knowledge of quality systems and regulatory requirements (21 CRF Part

　　11/210/211).

　　Strong knowledge of GMP, SOPs and quality control processes

　　Strong data integrity knowledge and practices.

　　Identifying, writing evaluating and closing OOS’s and investigations.

　　Strong knowledge of aseptic manufacturing and EM processes

　　Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

　　Strong understanding and experience operating within an GMP environment

　　Exceptional attention to detail and ability to keep track of multiple ongoing projects

　　Excellent oral and written communication skills

　　Proficient in MS Word, Excel, Power Point and other applications

　　Ability to perform duties with minimal supervision and must be adaptable to a dynamic and fast-paced environment

　　Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

　　Does this sound like you? If so, apply today.

　　#LI-ML1

　　#IND123

　　The salary range for this position is: $78,455.00 - $101,530.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

　　For additional benefits information, visit:

　　https://www.gilead.com/careers/compensation-benefits-and-wellbeing

　　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 system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .

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　　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 disability, genetic 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 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 [email protected] for assistance.

　　For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

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　　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 log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

　　Change The World With Us

　　Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.

　　We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.

　　While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.

　　Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. The health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.

　　The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation.