Supervisor Quality Control Analytical
Supervisor Quality Control Analytical
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$ 107185 - 138710
1 Vacancy
Job Description
Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR Tcell therapies have changed the paradigm. But were not finished yet.
Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
Gilead Sciences is looking to hire a Supervisor Quality Control Analytical.
Job Responsibilities & Requirements include but are not limited to:
Leadership
Experience with leadership people management and project management
Demonstrated leadership and management skills including establishing direction and goals and building good work ethics for the team
A minimum of 3 years experience supervising/managing is preferred
Routine Testing Support
The ideal candidate is well versed in various analytical methods (flow cytometry potency ELISA qPCR/ddPCR) in a cell therapy environment to support QC data review & COA generation to support ontime patient/stability testing and release
Supervision of all QC Analytical laboratory scheduling and testing to meet timelines
Supervisor/Manager review of QC Data and Generation of CoAs for ontime product release
Complete routine review of QC test data and related documents for stability reagent release etc.
Monitor and trend QC data results
Management of QC Analytical training program
Maintaining Operations
Provide updates/escalations at daily and weekly sitespecific and crosssite meetings Experience with method development/qualification tech transfer QC testing and laboratory deviations/investigations
Conduct investigations regarding out of specifications (OOS) results and address/manage deviations related to analytical procedures
Review & approve laboratory deviations and lab investigations
Review & approve as SME sitespecific and global SOPs and forms
Develop revise and review SOPs qualification/validation protocols and reports
Provides technical support for SOP & protocol writing & review.
Audits & Compliance
Working knowledge of quality systems and regulatory requirements 21 CRF Part 11/ 210/ 211 Knowledge of regulatory requirements for data integrity and practices. Audits & compliance
Knowledge of regulatory guidance and experience maintaining QC lab GMP compliance and audits
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
General
Experience with LIMS
Knowledge of CART manufacturing micro methods (e.g. sterility endotoxin and environmental monitoring) and equipment IQ/OQ/PQ/PV a plus
Proficient in MS Word Excel Power Point and other applications
Excellent interpersonal verbal and written communication skills are essential in this collaborative work environment
Comfortable in a fastpaced environment with minimal direction and able to adjust workload and flexibility based upon changing priorities
Gather metric information for use in continuous improvement of areas of responsibility Other duties as assigned
Knowledge:
Experience with analytical methods (flow cytometry potency ELISA and ddPCR/qPCR) in a cell therapy environment to support QC testing data reviews & COA generation to support patient/stability testing and release
Experience with leadership people management and project management
Experience with method development/qualification tech transfer QC testing and laboratory deviations/investigations
Knowledge of regulatory guidance and experience maintaining QC lab GMP compliance and audits
Specific Education & Experience Requirements:
5 years of relevant experience and a BS or BA. OR
3 years of relevant experience and a MS.
Prior management experience in pharmaceutical industry is preferred
For additional benefits information visit:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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 for assistance. NOTICE: EMPLOYEE POLYGRAPH PROTECTION 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. Please apply via the Internal Career Opportunities portal in Workday.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid longterm 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 systems ability to recognize and tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTFor Current Kite Pharma Employees and Contractors:
Required Experience:
Manager
Employment Type
Full-Time
