SanDiegoRecruiter Since 2001
the smart solution for San Diego jobs

Sr. QC Microbiologist, Quality Control

Company: Kite Pharma
Location: Oceanside
Posted on: October 13, 2019

Job Description:

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 Senior QC Microbiologist, Quality Control. Reporting to the Senior Manager (Microbiology), Quality Control in Oceanside, CA, in this role, you will be responsible for the execution of QC Microbiological program and methods in support of tech transfer, validation, lot release and in-process testing. The Sr. Microbiologist, under minimal supervision, will perform a broad range of activities to support the release of viral vector drug substances for clinical and commercial use. Responsible for the execution of raw material, in-process, final product testing, environmental monitoring and stability testing. Upkeep and maintenance of QC instrumentation and lab in GMP compliance. Work with outside testing labs and other Kite sites for method transfers. Ability and willingness to perform a wide variety of tasks - from those which are routine in nature to those which require independent thought and analysis. Responsibilities (include but are not limited to): Support the transfer and validation of microbiological methods to Oceanside, CA, QC. Provide technical oversight and training of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability). Complete routine record review of test data and related documents for raw material, in-process testing, drug-substance and drug product release. Generation of CoAs for product release. Conduct investigations regarding environmental monitoring (EM) action level excursions and out of specifications (OOS) results. Investigate and manage deviations related to microbiology procedures. Determine corrective/preventative actions (CAPA) and drive implementation. Generate trend reports on environmental monitoring and product release data. Frequently update management on trends. Implement corrective action plans when necessary. Gather metric information for use in continuous improvement of areas of responsibility. Develop, revise and review SOPs, qualification/validation protocols and reports. Assist in the management of laboratory activities and provide technical direction to staff. Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections. Monitor the GMP systems currently in place to ensure compliance with documented policies. Support the QC Microbiology and Aseptic Techniques Training programs. Support IT and QE to implement LIMS at Oceanside, CA Perform duties as needed Skills/Qualifications 7+ years of experience with BS degree in Microbiology or related scientific discipline 5+ years of experience with MS degree in Microbiology or related scientific discipline Strong experience in application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes, aseptic techniques, sterile gowning procedures and clean room operations. Strong Experience in applying GMP in QC lab in conformance to U.S., EU, and ROW standards. Experience in conducting lab investigations, writing deviations, implementing CAPA and initiating change control. Strong data integrity knowledge and practices. Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment Proficient in MS Word, Excel, Power Point and other applications 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 . For jobs in the United States: 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 contact careers@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Kite Pharma Employees and Contractors: Please log onto your Internal Career Site to apply for this job.

Keywords: Kite Pharma, San Diego , Sr. QC Microbiologist, Quality Control, Other , Oceanside, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


CDL A Team Driver - Up to 5,692 Miles Per Week
Description: Job Description TEAMS Come Experience the TLI Difference where... RESPECT is not just a word but a LifeStyle TLI TEAMS EXPECT : TEAM RUNS TEAM PAY
Company: Transco Lines, Inc.
Location: Placentia
Posted on: 10/24/2019

Amazon Holiday Delivery Driver - Lake Elsinore
Description: Amazon Holiday Delivery Driver Shifts: Early Morning, Day, Evening, Weekend Location: Irvine Job opportunities vary by location. We update postings
Company: Amazon Workforce Staffing
Location: Lake Elsinore
Posted on: 10/24/2019

Personal Banker 2 Register - Yorba Linda
Description: Important Note: During the application process, ensure your contact information email and phone number is up to date and upload your current resume prior to submitting your application for consideration. (more...)
Company: Wells Fargo
Location: Yorba Linda
Posted on: 10/24/2019


Amazon Delivery Driver - Lake Elsinore
Description: Amazon Holiday Delivery Driver Location: Carlsbad We update job postings daily opportunities for full-time delivery
Company: Amazon Workforce Staffing
Location: Lake Elsinore
Posted on: 10/24/2019

Part- Time Teller (20 Hours)- Mission Viejo Branch
Description: The Teller is an entry-level position responsible for assisting with the execution of branch activities, including day-to-day delivery of client-facing services and processing transactions, in coordination (more...)
Company: Citi
Location: Yorba Linda
Posted on: 10/24/2019

Amazon Delivery - Lake Elsinore
Description: Amazon Holiday Delivery Driver Location: Carlsbad We update job postings daily opportunities for full-time delivery
Company: Amazon Workforce Staffing
Location: Lake Elsinore
Posted on: 10/24/2019

Amazon Holiday Delivery Driver - Lake Elsinore
Description: Amazon Holiday Delivery Driver Location: Carlsbad We update job postings daily opportunities for full-time delivery
Company: Amazon Workforce Staffing
Location: Lake Elsinore
Posted on: 10/24/2019

CDL A Company Driver
Description: JOBS FOR EXPERIENCED CDL DRIVERS THAT HAVE EXCELLENT PAY, FULL BENEFITS AND A MENTOR PROGRAM No matter what drives you - a passion for the open road, career independence or financial security, jobs for (more...)
Company: Swift Transportation
Location: Highland
Posted on: 10/24/2019

Diesel Truck/Trailer Maintenance Technician
Description: As a Diesel Truck/Trailer Maintenance Technician mechanic at Walmart Supply Chain, you will be performing preventative maintenance and repairs on tractor and trailer equipment. Your responsibilities (more...)
Company: Walmart
Location: Yucaipa
Posted on: 10/24/2019

Get New Handyman Work Today - Preview Leads In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Yorba Linda
Posted on: 10/24/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Diego RSS job feeds