Quality Control Project Lead - Cell Therapy

Lonza•Houston, TX

3d•Onsite

About The Position

As a Quality Control Project Lead, you will play a critical role in supporting late-stage cell therapy programs as they progress through Phase III, PPQ, and commercial launch activities. This position serves as the primary Quality Control representative for assigned client programs, partnering closely with QC laboratories, Program Management, Quality Assurance, Manufacturing, and customers to ensure successful technology transfers, analytical readiness, and project execution.

Requirements

Bachelor's degree in a scientific discipline required.
Experience in Quality Control within a regulated biopharmaceutical, biotechnology, cell therapy, or related GMP environment.
Strong knowledge of cell therapy product development, technology transfer, analytical methods, validations, and product-specific qualification requirements.
Experience supporting new product introductions and cross-functional project execution.
Demonstrated technical writing experience, including preparation and review of scientific reports and GMP documentation.
Customer-facing experience with the ability to effectively manage client relationships and stakeholder communications.
Strong organizational, planning, and project management capabilities with proven ability to manage multiple priorities simultaneously.
Excellent verbal and written communication skills, attention to detail, and ability to influence cross-functional teams.

Nice To Haves

Experience with analytical techniques such as flow cytometry, ELISA, PCR, cell viability, or cell-based assays preferred.

Responsibilities

Lead Quality Control activities supporting client programs through technology transfer, process development, qualification, validation, and commercial readiness efforts.
Serve as the primary QC representative on cross-functional project teams, communicating testing status, timelines, risks, and analytical requirements to internal stakeholders and customers.
Coordinate new product introductions and support implementation of new methods, assays, and processes within the QC organization.
Author, review, and approve technical documentation including transfer plans, assay transfer protocols, reports, specifications, sampling plans, stability reports, comparability reports, and bridging studies.
Collaborate with BioAnalytical Services and laboratory teams to support method qualification, validation, and analytical lifecycle management activities.
Provide technical support for investigations, deviations, out-of-specification events, CAPAs, audits, and regulatory compliance activities.
Support stability programs by coordinating protocol initiation, tracking testing milestones, and ensuring timely reporting of results and project deliverables.
Act as a liaison between customers and internal teams, ensuring expectations, commitments, and project timelines are effectively managed and communicated.