Kite Pharma · 3 days ago
Assoc Director, Quality Control
Frederick, MD
Full-time
Onsite
Director/Executive
$165K/yr - $214K/yr
8+ years expKite Pharma is a biopharmaceutical company focused on developing innovative cancer immunotherapies. The Associate Director will lead the Quality Control Analytical Tech Services group, overseeing method development, validations, and cross-functional interactions to support commercial operations in CAR-T technology.
BiotechnologyHealth CareMedicalOncologyTherapeutics
Responsibilities
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
Qualification
Required
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
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
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Kite Pharma
Kite Pharma is a biotechnology company that designs and develops immune-based therapies to treat cancer indications.
1001-5000 employees
H1B Sponsorship
Kite Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (47)
2023 (54)
2022 (59)
2021 (53)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$335.38MKey Investors
Alta Partners
2017-08-28Acquired
2015-12-10Post Ipo Equity· $250.12M
2014-06-20IPO
Leadership Team
Craig Vermeyen
Director, Packaging and Labeling
Mark Jurgens
Executive Director, Head of External Scientific Collaboration
Recent News
BioWorld Financial Watch
2025-12-29
2025-12-07
Company data provided by crunchbase