Associate Director, Quality Control- Analytical Tech Services
We’re 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. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're 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
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 an Associate Director, to lead Quality Control Analytical Tech Services group, reporting to the Senior Director, Quality Control in Frederick, MD. In this role, you will lead a group and work closely with the Senior Director and other Associate Directors on supporting commercial operations in CAR-T technology.
You will work on complex projects involving qPCR/ddPCR, Flow cytometry and cell-based bioassays and lead efforts in automation development for analytical assays. You will have cross-functional interaction with personnel from other groups such as Quality Assurance, Analytical Development, Manufacturing, Material Management (MM) and Corporate teams.
Position Responsibilities (include but not limited to):
Provide technical support, process trending and procedural updates
Lead method validation and method transfers support continuous improvement, to support method/product/invalid trending, and to investigate laboratory/assay related findings.
Lead and support method development, validations, and transfers
Support laboratory investigations, deviations, CAPAs, change control as needed
Assist in investigation, identify root cause for critical deviations and determine CAPA for QC as needed
Establish data analytics to serve as metrics for monitoring trends in methods, products, and invalids
Support incoming tech transfers from AD/PD as needed
Author technical reports and protocols in support of cGMP activities
Supervise, train, and mentor junior staff
Create and/or revise procedures, SOPs, and test methods as needed
Support equipment and software lifecyle process
LIMS development and integration
Provide technical expertise for AD/PD, QA, Regulatory, Manufacturing, and Supply Chain as needed
Support and participate inspection readiness plans and participate during compliance audits (internal and external) and regulatory inspections.
Follow technology changes, recommends new technologies, advises on technology purchases and implementation if appropriate.
Additional duties as assigned.
Basic Qualifications:
Advanced scientific degree (i.e. MD, PharmD, PhD) and 2+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR
Master’s Degree and 8+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR
Bachelor’s Degree and 10+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR
High School Degree and 14+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment
Preferred Qualifications:
Experience supervising/managing analytical labs within the biotechnology or pharmaceutical industry
Well versed and experienced in bioanalytical methods working under GMP conditions.
Deep experience in applying GMP in QC lab in conformance to US, EU and ROW standards.
Experience in conducting investigations, writing deviations, implementing CAPA and initiating change controls.
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, GMPs, GLP
Ability to effectively negotiate and develop collaboration within teams and amongst individuals.
Demonstrated ability to create and maintain highly functioning teams.
Excellent interpersonal, verbal and written communications skills which are essential in this collaborative work environment
Comfortable in a fast-pace small company environment with 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:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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.
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Kite Pharmais 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 disability, geneticinformation 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 [email protected] for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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.
Kite Pharmaprovides 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 apply via the Internal Career Opportunities portal in Workday.