Scientist – QC Tech Services

Scientist / Senior Specialist

We’re 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. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're 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

Scientist – QC Tech Services

Kite, A Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential. Within the Quality Control department of our commercial cell therapy site in Hoofddorp, NL, the QC Science & Technology group is responsible for the coordination of new technology and/or method introduction into the department, support the QC department in providing scientific input to impact assessments and investigations and have oversight on the compliance status of the department (data trending, KPI/metrics tracking, Gemba walks, audit responses, etc).

We are seeking a highly motivated scientist to join the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy. In this role you will help to provide Quality Control oversight of commercial manufacturing of final drug product. You will be working on introduction of new bioanalytical methods and related instruments for cell therapy products tests, life cycle management and troubleshooting of current QC analytical test methods and enhancing GMP data integration. You will provide scientific support for the QC analytical group, assisting in documentation revisions, addressing method issues, generating impact assessments, and leading root cause investigations.

Responsibilities (include but are not limited to):

• Collaborate with the Global Kite network teams to discuss and coordinate new method/technology introductions and act as the liaison for Kite NL.
• Lead projects for the introduction and implementation of new methods and technology into the QC department at Kite NL.
• Lead projects for Tech Transfer of product related to Analytical methods.
• Author and revise analytical methods qualification/validation protocols, specifications, reports, and other documentation.
• Lead and participate in the validation of analytical methods and automation within QC.
• Trouble shooting for Analytical assays and implement CAPA when necessary.
• Support the department by identifying issues that may affect laboratory or facility monitoring or work processes.
• Monitor the GMP systems currently in place to ensure compliance with documented policies.
• Write and or Implement changes to controlled documents.
• Review proposed changes to systems, procedures, methods and submissions to regulatory agencies, as appropriate.
• Lead in investigations regarding OOS results. Address and manage deviations related to analytical procedures.
• Monitor and Trend Analytical and stability data and generate trending reports.
• Gather metric information for use in continuous improvement of areas of responsibilities.
• Interface with contract manufacturers to address QC analytical and related issues.
• Mentor junior staff.
• Act as SME during audits and Regulatory Inspections.
• Perform other duties as required.

Education, Experience, and Skills:

• Master’s degree in chemistry or biology with 10+ years industry experience in an analytical environment. Or PhD degree in Chemistry or Biology with 5+ years industry experience in an analytical environment.
• Expertise in analytical techniques such as Flow Cytometry, ELISAs, PCR, cell bioassays, and other biopharmaceutical testing methods.
• Working knowledge of cGMP and GLP.
• Project management skills are a plus.
• Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience.
• Proficient in Microsoft Office (Word, PowerPoint, Projects), with preferred excellence in Excel and JMP.
• Excellent verbal and written communication skills.
• Demonstrates effective time management skills and ability to work independently and as part of a team with internal and external clients, self-motivation, adaptability, and a positive attitude.

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.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

About Us

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.