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.
Kite Pharma 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 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 [email protected] for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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 Pharma 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 apply via the Internal Career Opportunities portal in Workday.
Skills Required
- Advanced scientific degree such as MD, PharmD, or PhD and 2+ years of experience in biologics or cell-gene therapy within a QC Analytical or Analytical Development environment
- Master's degree and 8+ years of experience in biologics or cell-gene therapy within a QC Analytical or Analytical Development environment
- Bachelor's degree and 10+ years of experience in biologics or cell-gene therapy within a QC Analytical or Analytical Development environment
- High school degree and 14+ years of experience in biologics or cell-gene therapy within a QC Analytical or Analytical Development environment
- Experience supervising or managing analytical laboratories within the biotechnology or pharmaceutical industry
- Experience with bioanalytical methods under GMP conditions
- Experience applying GMP in QC laboratories according to US, EU, and rest-of-world standards
- Experience conducting investigations, writing deviations, implementing CAPA, and initiating change controls
- Working knowledge of quality systems and regulatory requirements, including 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, QC, GMP, and GLP
- Ability to negotiate effectively and develop collaboration across teams and individuals
- Demonstrated ability to create and maintain highly functioning teams
- Excellent interpersonal, verbal, and written communication skills
- Ability to work in a fast-paced environment with minimal direction and adjust workload based on changing priorities
Gilead Sciences Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Gilead Sciences and has not been reviewed or approved by Gilead Sciences.
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Fair & Transparent Compensation — Pay is considered competitive and fair relative to roles, frequently cited as a standout strength. Feedback suggests compensation compares well within biotech and is a notable reason employees feel valued.
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Equity Value & Accessibility — Stock awards and an employee stock purchase program are consistently described as meaningful parts of total compensation. Equity components are seen as accessible and enhance long‑term wealth building.
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Retirement Support — A strong company 401(k) match with immediate vesting is often singled out as a differentiator. This support is perceived to significantly boost long‑term financial security.
Gilead Sciences Insights
What We Do
The way we see it, the impossible is not impossible. It’s simply what hasn’t been achieved yet. For more than 30 years, we’ve pursued it, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases. Creating Possible drives everything we do. It’s evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving lives of people around the world. For us, nothing is impossible – because of the people we work with, the communities we stand with and the partners we push forward with. Our ~12,000 employees band together through science, grit, compassion and courage to prove the impossible wrong. At Gilead, the tangible results of your contributions are evident. Where every individual matters. Where all employees can enhance their skills through ongoing development. And where we start every day with one question: “What’s next?” Social Media Guidelines: https://gilead.inc/3t1m7d5
