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 T-cell 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
Gileads mission is to discover develop and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.
We are seeking a highly motivatedindividualto join us as a Supervisor Quality ControlAnalytical reporting to the Associate Director Quality Control in Frederick MD. In this role you will be responsible for tasks associated with managing a groupresponsibleforanalyticaltesting and release of cell therapy final product using techniques such asqPCR/ddPCR Flow cytometry Cell-culture-ELISAand will havecross-functionalinteractionwith personnel from other QC groups Quality AssuranceAnalyticalDevelopment Manufacturing MaterialManagement(MM) andCorporateteams.
You will be responsible for the day to day oversight of the QC Analytical team during a 40-hour work week on the Swing shift Wednesday through Saturday 3:00pm to 1: shift is subject to change.
KeyResponsibilities(include but are not limited to):
Training onAnalyticalAssays usingqPCR/ddPCR Flow cytometry Cell-culture-ELISA
Supervise all QCAnalyticallaboratory testing usingqPCR/ddPCR Flow cytometry Cell-culture-ELISA
Responsiblefor the efficient operation of the QCAnalyticallabs including the planning coordination anddirectsupervision of activities conducted by QCAnalysts.
Manages QCAnalyticaltraining program
Hirementoranddevelopexceptional QC personnel
Works with QC raw materials team to establish testing process of raw materials
Generates of CoAs for product release
Develops revises and reviews SOPs tech transfer/qualification/validation protocols and reports
Conduct and/ordevelopinvestigation of OOS aberrant results andtrends in invalid assayin product and raw material testing.
Developand author deviations related to QCAnalyticalprocedures to investigate root cause impact and corrective and preventative actions.
Participate and/or leaddaily and weeklyteammeetings
Monitorsthe GMP systems currently in place to ensure compliance withestablished SOPs Policies cGMPs and other relevant regulatory requirements. Conduct investigations tosupportdeviations whenpreferred.
Review proposed changes to systems procedures methods and submissions to regulatory agencies as appropriate
Author controlled documents such as SOPs forms etc. asneeded.
Participate andSupportdevelopment and implementation ofOperationalExcellenceinitiativestoenhancelaboratory and staff efficiencies
Review proposed changes to systems procedures methods and submissions to regulatory agencies as appropriate
Other duties as assigned
Basic Qualifications:
MA / MS Degree with 3 years of analytical and/or cGMP operations and/or quality experience OR
BA/BS Degree with 5 years of analytical and/or cGMP operations and/or quality experience
Preferred Qualifications:
Experience supervising/managinganalyticallabs within the biotechnology or pharmaceutical industry
Demonstrated leadership and management skills including establishing direction and goals and guiding execution while fostering a team-based environment
Well versed in various analytical techniques such as Flow Cytometry ELISA PCR and cell bioassays and other applicable methods for the testing of biopharmaceuticals
Excellentexperience in applying GMP in QC lab in conformance to US EU and ROW standards.
Experience in conducting investigations writing deviations implementing CAPA and initiatingchangecontrols.
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) Quality Control GMPs GLP
Ability to effectively negotiate anddelivercollaborationwithin teams and amongstteam members.
Demonstrated ability tocreateand maintain highly functioning teams.
Excellentinterpersonal verbal and writtencommunicationsskills which are essential in thiscollaborativeworkenvironment
Comfortable in a fast-pace small companyenvironmentwith minimal direction and able to adjust workload based on changing priorities.
Comfortable in a fast-pace small companyenvironmentwith minimal direction and able to adjust workload based on changing priorities.
People Leader Accountabilities:
Create Inclusion - knowing the business value of diverse teams modeling inclusion and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills experience aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals purpose and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
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 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 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 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 systems ability to recognize and kill 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
