Associate Director, Quality Control- Analytical Tech Services

Biopharma Careers; Frederick (MD); On-site; USD 165,000 - 214,000; Full time

Job summary

Kite Pharma, a Gilead company, seeks an Associate Director to lead the Quality Control Analytical Tech Services group in Frederick, MD. You will drive QCs across qPCR, ddPCR, flow, and cell-based assays, partnering with QA, AD/PD, manufacturing, and regulatory teams to ensure robust analytical performance.

Lead method development, validation, transfers, investigations, CAPAs, and data analytics. Heavy emphasis on collaboration, compliance, and enabling commercial operations in CAR-T tech."

Qualifications

• Advanced scientific degree with relevant biologics/cell-gene therapy QC/analytical development experience.
• Experience supervising analytical labs in biotech/pharma.
• Knowledge of GMP, CGMP, QA and regulatory expectations.

Responsibilities

• Provide technical support, data trending, and procedural updates.
• Lead method validation, transfers, and continuous improvement efforts.
• Oversee method development, validations, and transfers.
• Support investigations, deviations, CAPAs, and change controls.
• Identify root causes of deviations and implement CAPAs for QC.
• Establish analytics to monitor trends in methods and products.
• Author technical reports and SOPs for cGMP activities.
• Supervise and mentor junior staff; train teams.

Skills

qPCR/ddPCR analysis

Flow cytometry

Cell-based bioassays

Automation development

Analytical method development

Data trending & MPC

Education

Advanced scientific degree (MD/PhD/PharmD)

Master's degree with 8+ years in biologics/cell-gene therapy QC/Analytical

Bachelor's degree with 10+ years in biologics QC/Analytical Development

Job description

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 adirectline between thatpurposeand our day-to-day work.Join us in our mission!

We are seeking a highly motivatedindividualto join us as an Associate Director, to lead Quality ControlAnalyticalTechServices 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 onsupportingcommercial operations in CAR-T technology.

You will work oncomplexprojectsinvolving qPCR/ddPCR, Flow cytometry and cell-based bioassays and lead efforts in automation development foranalyticalassays . You will havecross-functionalinteractionwith personnel from other groups such as Quality Assurance,AnalyticalDevelopment, Manufacturing, MaterialManagement(MM) andCorporate teams.

PositionResponsibilities(include but not limited to):

• Provide technicalsupport, process trending and procedural updates
• Lead method validation and method transferssupportcontinuous improvement, tosupport method/product/invalid trending, and to investigate laboratory/assay related findings.
• Lead andsupportmethod development, validations, and transfers
• Supportlaboratory investigations, deviations, CAPAs,changecontrol asneeded
• Assist in investigation, identify root cause for critical deviations anddetermineCAPA for QC asneeded
• Establish dataanalyticsto serve as metrics for monitoring trends in methods, products, and invalids
• Supportincoming tech transfers from AD/PD asneeded
• Author technical reports and protocols insupportof cGMP activities
• Supervise, train, andmentorjunior staff
• Createand/or revise procedures, SOPs, and test methods asneeded
• Supportequipment and software lifecyle process
• LIMS development and integration
• Provide technical expertise for AD/PD, QA, Regulatory, Manufacturing, and Supply Chain asneeded
• Supportand 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 inbiologics/cell-gene therapy in QCAnalytical,AnalyticalDevelopmentenvironmentOR
• Master’s Degreeand8+years’ experience inbiologics/cell-gene therapy in QCAnalytical,AnalyticalDevelopmentenvironmentOR
• Bachelor’s Degreeand10+years’ experience inbiologics/cell-gene therapy in QCAnalytical,AnalyticalDevelopmentenvironmentOR
• High School Degree and 14+years’ experience inbiologics/cell-gene therapy in QCAnalytical,AnalyticalDevelopmentenvironment

Preferred Qualifications:

• Experience supervising/managinganalyticallabs 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 initiatingchangecontrols.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, GMPs, GLP
• Ability to effectively negotiate anddevelopcollaborationwithin teams and amongstindividuals.
• 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.

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.

The salary range for this position is:

$165,495.00 - $214,170.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

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 .

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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 [e-mail] for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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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: