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QC Chemist

Employer
Kite Pharma
Location
Frederick, MD, United States
Start date
Sep 4, 2019

View more

Discipline
Quality, Quality Control, Science/R&D
Required Education
Bachelors Degree
Position Type
Full time
We are seeking a highly motivated individual to join us as a QC Chemist, Quality Control. You will report into the Supervisor, Quality Control in Frederick, MD. In this role you will be a hands-on resource for QC Analytical. Initially as part of the start-up activities, you will participate in performing Assay Technical Transfers including being trained on all the Analytical Assays and training other analyst on site. As the site transitions into operation, you will primarily be responsible for providing technical expertise, troubleshooting and assay execution for analytical testing utilizing flow cytometry, ELISA, and cell-based bioassay. You'll also contribute to the initiation and completion of quality records associated with analytical testing at the site.

Additional Responsibilities (include but are not limited to):
  • Provide Training on Analytical Assays
  • 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.
  • 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
  • 50% Travel during start-up activities


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

#LI-ZN1

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 contactcareers@gilead.comfor assistance.

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