Associate Director, Quality Control- Analytical Tech Services

Kite Pharma; Frederick (MD); On-site; USD 165,000 - 214,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Job summary

Kite Pharma in Frederick, MD is seeking an Associate Director to lead the Quality Control Analytical Technical Services group, reporting to the Senior Director of Quality Control. The role focuses on qPCR/ddPCR, flow cytometry, cell-based bioassays, and automation development for analytical assays in CAR-T technologies.

Responsibilities include method validation, transfers, investigations, CAPAs, and cross-functional collaboration with QA, Analytical Development, Manufacturing, MM, and corporate

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

Responsibilities

• Provide technical support, process trending and procedural updates
• Lead method validation and method transfers to 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 lifecycle process
• 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.

Skills

qPCR/ddPCR

Flow cytometry

Cell-based bioassays

Automation development for analytical

Cross-functional collaboration

Education

Advanced degree (MD/PhD/PharmD)

Master's Degree

Bachelor's Degree

High School Degree

Tools

LIMS

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 ControlAnalyticalTechServicesgroup, 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) andCorporateteams.

PositionResponsibilities(include but not limited to):

• Provide technicalsupport, process trending and procedural updates

• Lead method validation and method transferssupportcontinuous improvement, tosupportmethod/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.

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*.

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. 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 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.

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.