Biologics QC Director - Build & Scale Analytical Excellence

Vivid Resourcing; Cambridge (MA); Hybrid; USD 150,000 - 200,000; Full time

Job summary

A biotechnology company based in Cambridge, MA is seeking a Director of Quality Control to build and lead a high-performing QC organization. The role involves developing QC strategies aligned with IND-enablement, overseeing analytical testing, and ensuring compliance with GMP standards. The ideal candidate will have 10 to 15 years of QC experience, a strong understanding of regulatory frameworks, and proven leadership capabilities. This position offers a hybrid work model.

Qualifications

• 10 to 15 years of QC experience in biologics or advanced modalities.
• At least 5 years in leadership roles.
• Strong understanding of global GMP and biologics regulatory frameworks.

Responsibilities

• Build and lead a high-performing QC organization.
• Develop QC strategy for IND-enablement and early-phase manufacturing.
• Oversee analytical testing and method lifecycle management.

Skills

Analytical technologies for biologics

Leadership skills

Cross-functional collaboration

Regulatory compliance

Education

MS or PhD in relevant field

Tools

HPLC

UPLC

MS

ELISA

qPCR

Job description

A biotechnology company based in Cambridge, MA is seeking a Director of Quality Control to build and lead a high-performing QC organization. The role involves developing QC strategies aligned with IND-enablement, overseeing analytical testing, and ensuring compliance with GMP standards. The ideal candidate will have 10 to 15 years of QC experience, a strong understanding of regulatory frameworks, and proven leadership capabilities. This position offers a hybrid work model.