Sr Research Scientist I, Analytical Operations

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Oct 15, 2019
Ref
R0010089
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Kite, a Gilead Company, is seeking a highly-motivated individual to join us as a Sr. Research Scientist I in the Analytical Operations group within Commercial Quality Control (QC). The individual will work within the commercial QC organization, and will have significant cross-functional interaction with personnel from Clinical QC, Quality Assurance, Manufacturing and Corporate teams.

The Sr. Research Scientist I within the QC Analytical Operations group will have an overall responsibility, among others, for providing technical expertise for the optimization of analytical and/or microbiology test methods, driving method validation studies per ICH guidelines, supporting cross-site method transfer activities, assisting in improvement of quality metrics and promoting a culture of quality and compliance within QC.

Key Responsibilities include (but not limited to):
  • Support lifecycle management of commercial release methods by evaluating and proposing enhancements to the test methods.
  • Support activities related to the transfer and validation of analytical/microbiology methods from Clinical to Commercial QC, and commercial QC to external testing sites.
  • Assist with deviation, lab investigations, CAPA and change control activities at Kite pharma and contract labs, as needed.
  • Support inspection readiness activities.
  • Develop, revise and review SOPs, protocols and technical reports, as needed.
  • Participate in generating and providing training using instruction led training material.
  • Responsible for generating trending charts for monitoring method performance, product quality and/or test method invalid rates.

Qualifications:
  • Ph.D with 5+ years or Master with 8+ years of experience in a GMP environment
  • Experience in a number of analytical techniques, including but not limited to, Flow Cytometry, q PCR, ddPCR, ELISA, Cell Viability measurement, etc. Familiarity with microbiology tests is a plus.
  • Experience in performing method validation studies and supporting method transfer activities
  • Familiarity with FDA, ICH and GMP guidelines, as they pertain to operating within a QC lab
  • Ability to think critically and demonstrate troubleshooting/problem solving skills
  • Experience in conducting lab investigations, writing deviations, implementing CAPAs and initiating change controls
  • Excellent skills in Microsoft Office, data analysis software, and other related applications
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities


#LI-MY1

#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.

For jobs in the United States:

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 contactcareers@gilead.comfor assistance.

For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE 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.

Gilead 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:

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