Team Lead, Quality Control Microbiology
- Employer
- Kite Pharma
- Location
- Frederick, MD, United States
- Start date
- Jul 2, 2019
View more
- Discipline
- Quality, Quality Control, Science/R&D, Microbiology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
You need to sign in or create an account to save a job.
We are seeking a highly motivated individual to join us as a Team Lead, Quality Control. You will report into the Associate Director, Quality Control in Frederick, MD and be a hands-on resource for QC Analytical. In this role you will be responsible for the day to day oversight of the QC Microbiology team. You will also be responsible for environmental monitoring program, water and utility testing and final product microbiological testing.
Additional Responsibilities (include but are not limited to):
Requirements:
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 contactcareers@gilead.comfor 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.
Additional Responsibilities (include but are not limited to):
- Team Lead of all QC Micro laboratory testing
- Sustain environmental monitoring program for Kite
- Management and optimization of the Aseptic gowning training and qualification program
- Management of QC Microbiology training program
- Work with QC raw materials team to establish specifications and testing process of raw materials.
- SME on investigations of sterility and environmental excursions
- Monitor and trend data
- Assemble reports on findings from environmental monitoring of Kite's cGMP facility. Frequently update management on environmental trends. Implement corrective action plans when necessary
- Complete routine record review of test data and related documents for in-process and routine environmental monitoring testing, drug product release. Generation of CoAs for product release
- Develop, revise and review SOPs, qualification/validation protocols and reports
- Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro 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
- Other duties as assigned
Requirements:
- BS or BA in Microbiology or related discipline and 7 years of relevant experience or MS in Microbiology or related discipline and 4 years of relevant experience
- Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team
- Minimum of 7 years' experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is preferred.
- Minimum of 3 years' experience supervising/managing microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry
- Well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to cell therapy product
- Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes, endotoxin testing and sterility testing of final product
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 contactcareers@gilead.comfor 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.
You need to sign in or create an account to save a job.
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert