Description
Director of Cell Therapy Analytical Quality Control (QCA)
Location: El Segundo, CA
Compensation: $185,000 to $220,000 annually (commensurate with experience)
Position Type: Direct Hire
Overview:
Kelly® Science & Clinical is looking for an experienced Director to lead Quality Control Analytical (QCA) efforts in cell therapy. This senior-level role is focused on ensuring the successful design, implementation, and regulatory compliance of QC processes for cell therapy programs. The ideal candidate will oversee regulatory document creation, manage testing processes for lot release, stability, and characterization, and provide leadership for the QC analytical method lifecycle—from validation and troubleshooting to trending. You will also serve as the primary liaison across teams to ensure smooth coordination and quality assurance for cell therapy programs.
Key Responsibilities:
• Regulatory Documentation Management: Direct the creation and maintenance of critical regulatory submissions, such as IND and BLA applications, for cell therapy programs.
• QC Oversight: Manage all aspects of Quality Control activities, coordinating the testing of in-process materials, lot release, stability, and characterization with internal teams.
• Method Development & Documentation: Approve, develop, and document methodologies, including product specifications, testing protocols, SOPs, and analytical method validation for cell therapy products.
• Team Leadership & Development: Lead and mentor QC staff, handling recruitment, training, work distribution, performance management, and conflict resolution.
• Compliance & Quality Systems: Ensure QC activities are compliant with GMP, regulatory requirements, and internal quality standards.
• Budget Management: Oversee and manage the QC operational budget, tracking expenditures and ensuring financial alignment with project needs.
• Inspection Readiness & Support: Prepare the QC team for regulatory inspections, maintaining a high level of inspection readiness throughout cell therapy development.
• Data Review & Trending: Analyze QC data and trends to ensure reliable, scientifically accurate results that support regulatory submissions.
• Investigation & Troubleshooting: Lead investigations into analytical issues, providing thorough troubleshooting and resolution while keeping cross-functional teams updated.
• Cross-Functional Collaboration: Contribute to broader business initiatives by leading ad-hoc projects and providing expert support for additional departmental needs.
Required Qualifications:
• Education:
o Bachelor's degree in Biology, Chemistry, or a related scientific field with at least 15 years of relevant experience; or
o Master's degree in Biology, Chemistry, or a related field with at least 10 years of experience; or
o Ph.D. in Biology, Chemistry, or a related field with at least 8 years of relevant experience.
• Experience:
o At least 8 years of leadership experience in cGMP lab operations within the pharmaceutical or biotechnology industry.
o Proven success in managing and mentoring QC teams, particularly in a cell therapy or biologics environment.
o Experience with regulatory inspections, including cell therapy or biologics submissions (e.g., IND, BLA).
• Knowledge & Skills:
o Expertise in drafting regulatory documents, especially for cell therapy INDs and BLAs.
o In-depth understanding of QC assays, method validation, and transfer for cell therapies.
o Strong knowledge of cell culture, biologics manufacturing, and analytical characterization techniques.
o Extensive experience with GMPs and regulatory compliance requirements.
o A strategic, solutions-focused approach to managing quality assurance processes and troubleshooting issues.
o Excellent leadership abilities, with proven skills in managing teams and aligning their efforts with business objectives.
o Strong project management skills, including the ability to prioritize and manage multiple initiatives simultaneously.
o Excellent communication skills, with the ability to interface with various stakeholders, including senior management and external parties.
Work Environment:
• This role is based on-site in El Segundo, CA, and includes both lab and office work to manage QC programs for cell therapy.
• Standard business hours, with flexibility needed for critical activities and inspections.
Next Steps:
Once you apply, our team at Kelly Science & Clinical will review your qualifications. If your experience aligns with the role, we will contact you to discuss the next steps. Even if this position isn't the perfect match, we will keep you in our network for future opportunities.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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