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Director, Quality Control

Company: Kite Pharma
Location: Santa Monica
Posted on: March 22, 2020

Job Description:

Job DescriptionKite is seeking a Director, Quality Control who will be responsible for clinical site Quality Control, including analytical, microbial, stability and sample management groups and activities. You will also be tasked with staging appropriate validation of bioanalytical methods for cell therapy products and in-process/final product testing and stability testing methods.Responsibilities include (but are not limited to):Manage analytical, microbial, stability and sample management groups to ensure timely testing.-- Manage method transfer and phase appropriate qualification/validation of analytical methods from Analytical Development to QC as well as the transfer and validation of methods to a contract-testing lab.Responsible for OOS, deviations.Draft analytical and stability sections of BLA, IND.Responsible for method transfer to commercial site, method comparability, training of analysts.Monitor and trend dataAssemble reports on product release test monitoring of Kite's cGMP facility.-- Frequently update management on trends.-- Implement corrective action plans when necessaryCMO and OTL tracking to complete lot dispositionComplete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product releaseResponsible for stability program of clinical stage products.Support in-process and final specification system for drug substance and drug product of Kite cell therapy product.Establish user requirements for purchase, qualification of Kite's QC analytical equipment.-- Work with internal and external resources to maintain equipment in an optimal state.Participate in PAI, defend regulatory audits and draft response.Prepare of dossiers and data packages for interactions between Kite and Regulatory agencies.-- Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.Develop, revise and review SOPs, qualification/validation protocols and reports.Monitor the GMP systems currently in place to ensure compliance with documented policies.Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.Gather metric information for use in continuous improvement of areas of responsibility.Perform other duties as required.Qualifications:PhD molecular biologist or biochemist with 5+ years' of Quality Control experience or MS with 10+ years' of Quality Control experience in the biotech and/or pharmaceutical industry.Well versed in various analytical techniques such as FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals, preferred.Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)Minimum 2 years of QC lab management experience in the biotech and/or pharmaceutical industryQuality Control, GMPs, bioanalytical method validationStrong knowledge of GMP, SOPs and quality control processesStrong knowledge of technical writing for BLA, IND.--Identifying, writing evaluating and closing OOS's and investigationsStrong knowledge of cell culture techniquesEquipment and utility IQ/OQ/PQ/PVProficient in MS Word, Excel, Power Point and other applicationsAbility to communicate and work independently with scientific/technical personnel.Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing prioritiesSelf-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job descriptionAbility to think critically and demonstrate troubleshooting and problem solving skillsExcellent interpersonal, verbal and written communication skills

Keywords: Kite Pharma, Santa Monica , Director, Quality Control, Executive , Santa Monica, California

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