QC Project Lead: Tech Transfer & CGMP Compliance (On-site)

Lonza; Pearland (TX); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Disability insurance

Employee assistance programs

Paid time off

Job summary

Lonza in Pearland, TX (on-site) seeks a QC Project Lead to drive the introduction of new methods and processes into the QC department through technology transfer. The role provides technical support for investigations, and acts as the QC representative on project teams involved in cell and gene therapy product testing.

The successful candidate will lead transfer plans, review regulatory guidance, and ensure CGMP compliance while writing and approving test records and QC documentation.

Qualifications

• Minimum 3–5 years of experience in Quality Control.
• Bachelor’s degree in a scientific discipline is required.
• Experience with method validation/qualification and technology transfer in a QC environment.
• Knowledge of biological and cell-based assays (flow cytometry, ELISA, HPLC, ddPCR, qPCR) preferred.

Responsibilities

• Lead tech transfer activities including development of transfer plans, protocols, and reports.
• Provide QC representation in project team meetings and communicate project status and timelines.
• Review regulatory guidance and internal policies to ensure compliance with cGMP standards.
• Write, review, and approve test records, sampling plans, specifications, and QC documentation.
• Support stability programs and track testing progress and deliverables.
• Collaborate with cross-functional teams including QA, MSAT, and manufacturing.
• Assist with deviations, OOS investigations, CAPAs, and audit responses.

Skills

Quality Control

Regulatory compliance

Project management

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

Tools

Flow cytometry

ELISA

HPLC

ddPCR

qPCR

Job description

Lonza in Pearland, TX (on-site) seeks a QC Project Lead to drive the introduction of new methods and processes into the QC department through technology transfer. The role provides technical support for investigations, and acts as the QC representative on project teams involved in cell and gene therapy product testing.

The successful candidate will lead transfer plans, review regulatory guidance, and ensure CGMP compliance while writing and approving test records and QC documentation.