Associate Research Scientist, Process Impurities Development
Associate Research Scientist, Process Impurities Development
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$ 99705 - 129030
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
We are seeking a highly motivated Associate Research Scientist to join our Process Impurities Development team within the Method Development and Automation function. This role focuses on the development optimization and validation of analytical methods supporting residual impurity testing host cell protein (HCP) analysis compendial testing and raw material characterization to support gene and cell therapy manufacturing.
The successful candidate will bring strong experience with ELISA ELLA and molecular biology techniques along with a working knowledge of ICH USP and EU regulatory guidelines for analytical method development. You will play a critical role in ensuring product safety and consistency by supporting process development and tech transfer activities across the organization.
Title: Associate Research Scientist I Process Impurities Development
Team: Analytical Development Process Impurities Method Development
Reports to: Principal Scientist Analytical Ops
Key Responsibilities
Develop and optimize analytical methods for detection and quantification of residual impurities including Host Cell Proteins and nucleic acids
Perform and validate ELISA- and ELLA-based assays for impurity profiling
Execute molecular biology methods (e.g. qPCR ddPCR) to support residual DNA or RNA detection
Conduct compendial testing per USP EP and other regulatory guidelines for raw materials and in-process components
Design and execute method validation studies in accordance with ICH USP and EU requirements
Troubleshoot assay performance issues and implement continuous improvements
Collaborate cross-functionally with Process Development Quality and Manufacturing teams to integrate analytical methods into development workflows
Document experimental protocols validation reports and supporting SOPs in accordance with GDP and regulatory standards
Maintain compliance with GMP and internal quality systems
Basic Qualifications
BA / BS and 4 years of relevant experience
MA / MS and 2 years of relevant experience
Degree in Biochemistry Molecular Biology Analytical Chemistry or a related discipline
Preferred Qualifications
Demonstrated expertise in ELISA ELLA (e.g. ProteinSimple Ella platform) and quantitative molecular assays
Familiarity with impurity testing for biologics or gene therapies (e.g. HCP assays residual DNA/RNA enzyme activity)
Proven experience developing and validating analytical methods in alignment with ICH Q2(R2) USP and EU guidelines
Working knowledge of compendial methods and regulatory standards (USP <85> <61/62> <1132> etc.)
Proficiency in data analysis using software such as SoftMax Pro GraphPad Prism and JMP
Excellent technical writing skills for protocols reports and submissions
Strong collaborative mindset and communication skills
Comfortable working in a dynamic biotech environment with evolving priorities and timelines
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 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:
IC
Employment Type
Full-Time
