Gilead Sciences, Inc.
* Perform testing of raw materials, intermediates, and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.* Work with internal and external resources to maintain lab in an optimal state.* Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product release.* Maintains laboratory instruments for calibration and routine maintenance* Author or revise SOPs, qualification/validation protocols and reports.* Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.* Provide updates at daily and weekly meetings.* 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.* Bachelor’s Degree OR* AA Degree and 2+ years’ experience in biotechnology or related field and Quality Control experience OR* High School Degree and 3+ years’ experience in biotechnology or related field and Quality Control experience* Thorough knowledge of GMP, SOPs and quality control processes.* Identifying, writing, evaluating, and closing OOS’s and investigations.* Proficient in MS Word, Excel, Power Point and other applications.* Strong written and verbal communication skills.* Ability to communicate and work independently with scientific/technical personnel.* Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.* Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).* Preferred: Experience in the biotech and/or pharmaceutical industry.* Potential shifts are Sunday – Wednesday or Wednesday – Saturday. Business need may require alternate work schedule, such as swing shift hours.Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. #J-18808-Ljbffr
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.* Bachelor’s Degree OR* AA Degree and 2+ years’ experience in biotechnology or related field and Quality Control experience OR* High School Degree and 3+ years’ experience in biotechnology or related field and Quality Control experience* Thorough knowledge of GMP, SOPs and quality control processes.* Identifying, writing, evaluating, and closing OOS’s and investigations.* Proficient in MS Word, Excel, Power Point and other applications.* Strong written and verbal communication skills.* Ability to communicate and work independently with scientific/technical personnel.* Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.* Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).* Preferred: Experience in the biotech and/or pharmaceutical industry.* Potential shifts are Sunday – Wednesday or Wednesday – Saturday. Business need may require alternate work schedule, such as swing shift hours.Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. #J-18808-Ljbffr