Director, Quality Control
Santa Monica, CA, USA | Leading Pharmaceutical / Biotech Company
Industry:Pharmaceutical / Biotech
Job Description:56 people have viewed this job
Kite 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 data
Assemble reports on product release test monitoring of Kite’s cGMP facility.Frequently update management on trends.Implement corrective action plans when necessary
CMO and OTL tracking to complete lot disposition
Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release
Responsible 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.
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 industry
Quality Control, GMPs, bioanalytical method validation
Strong knowledge of GMP, SOPs and quality control processes
Strong knowledge of technical writing for BLA, IND.
Identifying, writing evaluating and closing OOS’s and investigations
Strong knowledge of cell culture techniques
Equipment and utility IQ/OQ/PQ/PV
Proficient in MS Word, Excel, Power Point and other applications
Ability 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 priorities
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
Ability to think critically and demonstrate troubleshooting and problem solving skills
Excellent interpersonal, verbal and written communication skills