QC Site Lead – Gene Therapy Manufacturing (Startup)

Regulatory Jobs; Lebanon (IN); Presencial; USD 125.000 - 202.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Company bonus

401(k)

Health insurance

Life insurance

Descripción de la vacante

Lilly is building LP2 in Lebanon, Indiana, to manufacture advanced therapies and gene therapy products. The Site QC Lead will define QC strategy for internal and external labs, oversee start-up operations, and ensure compliant testing and release of materials.

You will collaborate with site leadership and external partners to support timely product delivery. The role demands extensive cGMP experience, robust laboratory leadership, and readiness for ongoing inspections, with a focus on quality

Formación

• 8+ years of cGMP commercial manufacturing experience in QC or related disciplines.
• 8+ years of direct laboratory leadership and supervision of QC personnel.
• Experience with regulatory inspection readiness and executing inspections.

Responsabilidades

• Set site QC strategy for internal and external laboratory operations including receipt, test, release, and stability samples.
• Size and shape the site’s analytical footprint with leadership alignment for current and future programs.
• Provide laboratory leadership during start-up and ongoing operations; plan workload and ensure compliance.
• Oversee external partner testing to maintain quality standards and oversight.
• Ensure adherence to procedures, methods, and regulatory commitments; lead audit readiness.

Conocimientos

cGMP

QC leadership

Laboratory leadership

Regulatory inspections

Start-up experience

Educación

Bachelor's degree in science

Herramientas

Root Cause Analysis

Descripción del empleo

Lilly is building LP2 in Lebanon, Indiana, to manufacture advanced therapies and gene therapy products. The Site QC Lead will define QC strategy for internal and external labs, oversee start-up operations, and ensure compliant testing and release of materials.

You will collaborate with site leadership and external partners to support timely product delivery. The role demands extensive cGMP experience, robust laboratory leadership, and readiness for ongoing inspections, with a focus on quality