QC Specialist I - Cell Therapy
QC Specialist I - Cell Therapy
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$ 80325 - 103950
1 Vacancy
Job Description
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
Responsibilities (include but are not limited to):
Perform testing of raw materials intermediates final products and stability by following analytical methods.
Maintain calibrate and operate equipment and instruments supporting cell bioassays Flow Cytometry ELISA and PCR assays.
Track and test products according to Stability protocols.
Work with internal and external resources to maintain lab in an optimal state.
Monitor and trend data 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.
Assist in the preparation of dossiers and data packages for interactions between Kite ( GILEAD) and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
Develop revise and review SOPs qualification/validation protocols and reports.
Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures. Provide updates at daily and weekly meetings.
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.
Gather metric information for use in continuous improvement of areas of responsibility.
Perform other duties as required.
Basic Requirements:
- BS Degree in a scientifically oriented field and 2 years related work experience
- MS Degree in a scientifically oriented field and 0 years related work experience
Preferred Requirements:
2 years of industry experience working in a the biotech and/or pharmaceutical industry Quality related role
Strong knowledge of GMP SOPs and quality control processes.
Identifying writing evaluating and closing OOSs and investigations.
Proficient in MS Word Excel Power Point and other applications.
Strong written and verbal communication skills.
Ability to communicate and work independently with scientific/technical personnel
Well versed in various analytical techniques such as Flow Cytometry ELISAs PCR and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
Potential shifts are Sunday Wednesday or Wednesday Saturday. Business need may require alternate work schedule such as swing shift hours.
For additional benefits information visit:
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 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 for assistance. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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. Please apply via the Internal Career Opportunities portal in Workday.
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:
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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:
Required Experience:
Unclear Seniority
Employment Type
Full-Time
