QC Team Lead

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Kite we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

As QC Team Leader Microbiology department, you will be responsible for the lab operations and lead a group of QC microbiologists (approx. 10 analysts) whose primary goal is to test commercial final drug product and perform Environmental monitoring of the Manufacturing cleanrooms.

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.

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

Department Description

As Supervisor for QC microbiology, you will be joining a team in which people of all backgrounds and experiences are respected, and where working together while being focused on saving lives by finding the cure for cancer is a daily activity.

The QC microbiology group is part of the Quality Control department. The Quality Control department ensures consistent quality throughout the manufacturing process by providing accurate testing of Incoming Goods, in-process samples, final product, environmental monitoring, and stability samples.  The team is diverse, enthusiastic, and hard working.

You will be reporting to the Associate Director QC microbiology.

Your Responsibilities

In this role, you will lead a group of QC microbiologists, whose primary goal is to perform environmental monitoring of the clean rooms and to test final drug product while ensuring total cGMP compliance. The supervisor will manage all resources (analysts, equipment, batches, and documentation) to ensure timely delivery of high-quality sampling, testing and reporting.

Due to the nature of the product and speed of treatment, this role requires a high level of proficiency and ownership of the process.

Your responsibilities, among others, will be:

• Lead one of the QC microbiology groups, act as an advisor and technical resource to the team (approx. 10 technicians)

• Coordinate and perform Training of new personnel and manage training records for the QC microbiology group

• Coordinate and work with the team to troubleshoot issues and provide solutions

• Organize and prioritize daily tasks to ensure an efficient process and timely analysis of batches

• Monitor the GMP systems currently in place to ensure compliance with documented policies and safety regulations

• Lead investigations and support continuous improvement initiatives

• Write, review and/or implement deviations, change controls and CAPAs

• Write, review and/or implement changes to controlled documents (SOPs, Specifications, Methods, etc.)

• Act as a SME during audits and Regulatory Inspections

• Interact with other departments and within QC in a professional manner and join in applicable meetings.

Your Profile

The ideal candidate has a can-do attitude and thrives in a fast-paced environment. Because the QC group is involved daily with multiple departments, a strong ability to communicate and coordinate is essential to ensure a smooth and efficient process.  The ideal candidate should possess a technical mind but is also able to think outside the box in order to use logic and sound judgement to provide solutions to problems.

Your profile

• You have a BSc degree in Life Science or related field, with proven leadership experience in the Pharmaceutical Industry.

• You have previous working knowledge of GMPs.

• Proficient in application of QC principles, concepts, industry best practices and standards

• You have been performing and concluding investigations, writing and implementing deviations, change controls and CAPAs

• Experience in writing or updating SOPs and analytical methods

• Experience with participating in audits (regulatory, customers, inter-organizational)

• You have a leader with a can-do attitude, roll up your sleeve’s mentality and comfortable in a fast-paced environment

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 .

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.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.