QC Analytical Specialist II

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Oct 04, 2019
Ref
R0009621
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time
Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

We are seeking a highly-motivated individual to join us as a Quality Control QC Analytical Specialist II in the Commercial Quality Control (QC) organization. You will work directly with the analytical QC testing function, and will have cross-functional interaction with personnel from other QC groups, Quality Assurance, Analytical Development, Manufacturing and Corporate teams.

You will primarily be responsible for providing technical expertise, troubleshooting and assay execution for analytical testing utilizing flow cytometry, ELISA, and cell-based bioassay. Additionally, you will be accountable for method performance monitoring and trending. You'll also contribute to the initiation and completion of quality records associated with analytical testing at the site.

Key Responsibilities include (but are not limited to):
  • Provide technical support for assay performance and troubleshooting of analytical issues in the context of a GMP laboratory.
  • Represent Commercial QC as a primary point of contact for analytical methods in collaboration with Manufacturing and Analytical Development organizations.
  • Represent Commercial QC on Product Quality Teams and to other stakeholders.
  • Author and revise processes and procedures for analytical method and associated work streams.
  • Establish processes and procedures for purchasing, implementation, training and maintaining QC equipment in collaboration with method subject matter experts
  • Coordinate with stakeholders for equipment validation and manage validation activities in alignment with established timelines
  • Responsibility for ensuring electronic data meets Part 11 requirements in alignment with internal procedures
  • Lead teams to support deviations, investigations, CAPAs and change control activities as needed
  • Identify and lead teams for lean improvement activities
  • Author and support regulatory filings and response to questions
  • Support inspection readiness activities
  • Participate in generating training module and instruction led training material
  • Other duties as required


Qualifications:
  • Bachelor's degree with 4+ years of experience, preferably in a GMP environment or Master's degree with 2+ years of experience, preferably in a GMP environment.
  • Experience with flow cytometry, cell-based bioassays, and ELISA methodologies
  • Experience with method qualification and transfer activities
  • Experience in performing equipment validation activities
  • Familiarity with FDA, ICH and GMP guidelines
  • Familiarity with Part 11 requirements
  • 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


IND123

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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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