Veterans Preferred - Scientist, Method Development -Analytical

Company: Kite Pharma
Location: Santa Monica
Posted on: May 11, 2022

Job Description:

Military Veterans are Encouraged to Apply. -Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

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

Job Description

Analytical Development is looking for a talented and highly motivated Research Scientist (RS), with a background in immunology and/or cancer biology, to lead method development for characterization and release of drug substance and drug product for T cell therapies. The ideal candidate will have an extensive knowledge of retroviral and lentiviral vectors and T cell-based products.

The RS will be responsible for independently designing, planning and executing analytical method development of immunoassays, impurities assays, and molecular biology assays using Quality by Design (QbD) and design of experiment (DOE) approaches. The ideal candidate will have an extensive experience in method development, method qualification/validation of PCR-based methods including ddPCR and qPCR, and ELISA-based method development using traditional ELISA, Luminex, MSD, Alphalisa platforms.

The candidate will generate, analyze, interpret, and present experimental data, and carefully document resultant information. They will author, review, and edit test methods and SOPs, protocols, reports, and assist in the technical review of CMC sections and supporting documents for regulatory filings. In partnership with Research and Translational Medicine, the RS will work cross-functionally to identify new technologies and opportunities for continuous process/product improvement.

This role has a significant scope of growth which will evolve and expand over time to include mentoring junior team members, functioning as a vector and a T cell biology SME and working with key stakeholders to build and advance product characterization workflows to enhance product understanding.

Responsibilities and Duties

• Independently design, execute and document analytical method development and qualification in support of process development, product release and stability, and product characterization of drug substance (vector) and T cell drug products.
• Employ quality by design (QbD) and design of experiment (DOE) approaches for method development to quickly identify robust operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines.
• Act as a SME for Analytical Development and responsible for knowledge/technology transfer of in-process and product characterization methods across Kite sites.
• Use forward looking perspective to contribute towards strategic (go/no-go) decisions as well as recommend new technologies for the Process Development team to pursue.
• Participate as a key member in cross-functional teams that align on strategies to characterize in-process and product attributes in Kite cell therapy products.
• Function independently in non-routine development activities and project goals.
• Author and review technical documents (e.g., development reports, SOPs, and technical reports).
• Maintain accurate documentation of experiments in ELN and reports.
• Function as a key contributor to Process Development knowledge by remaining up to date on scientific literature and the newest developments in relevant fields.
• Effectively communicate scientific findings pertaining to process/drug development via external and internal presentations, publications, patents, white papers, etc.
• Demonstrate leadership traits through team participation, internal consulting, and mentoring of junior team members.
• Work closely with clinical and commercial QC during knowledge, method transfer and co-qualification.
• Develop experimental approaches using new analytical technologies.
• Maintain, calibrate and operate analytical equipment and instruments.
• Ensure that departmental areas are maintained per 5S guidelines.
  
  Basic Requirements
  
  
  • Ph.D/PharmD with 0+ years of industry/research experience; OR
  • MA/MS/MBA with 6+ years of industry experience; OR
  • BA/BS with 8+ years of industry experience; OR
  • High School Diploma with 12+ years of industry experience
    
    Additional Qualifications
    
    
    • Strong scientific background in immunology, cancer biology or cell biology.
    • In-depth knowledge of T cell biology and immune cell therapy (e.g., viral vectors, CAR T functional assays) is strongly desired.
    • Expertise in analytical method development and qualification of plate-based immunoassays, impurities assays, and molecular biology (e.g. RT-PCR, ddPCR, ELISA, MSD, Luminex).
    • Knowledge of QbD approaches to analytical method development including gap and risk assessments, DOE and statistical analysis.
    • Experience with cell culture (aseptic techniques, human cell line expansion); experience with human primary cell culture and isolation of immune cells is a plus.
    • Excellent skills in Microsoft Office, data analysis software (e.g. JMP, Graphpad Prism, Geneious, SoftMax Pro), and other applications.
    • Ability to think critically and demonstrate troubleshooting and problem-solving skills.
    • Evidence of high level of scientific expertise demonstrated through scientific publications, literature review and scientific conference participation is preferred.
    • Overall understanding of drug development process and its impact on projects, goal and timelines is preferred.
    • Experienced in establishing and maintaining internal and external collaborations, especially with outside centers of excellence in field of specialization.
    • Excellent oral and written communication and presentation skills.
    • Understanding of GxP is preferred.
      
      #LI-ML1
      
      #IND123
      
      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 careers@gilead.com for assistance.
      
      Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since 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 a reasonable accommodation.
      
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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.
      
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      For Current Kite Pharma Employees and Contractors:
      
      Please log onto your Internal Career Site to apply for this job.

Keywords: Kite Pharma, Santa Monica , Veterans Preferred - Scientist, Method Development -Analytical, Other , Santa Monica, California