Director of Cell Therapy Analytical Quality Control (QCA)

Job Title: 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.