Associate Director, Analytical Development & QC – Biologics

Automatic Data Processing, Inc.; Malvern (Chester County); On-site; USD 180,000 - 240,000; Full time

Job summary

Uniquity Bio, a clinical-stage biotechnology company, seeks an Associate Director of Analytical Development & Quality Control in Malvern, PA. The role leads analytical development, QC, and regulatory submission activities, shaping strategy for late-stage development and BLA readiness.

The position requires strong protein chemistry knowledge, cross-functional influence, and ability to work with CMOs and contract labs while ensuring GMP compliance and timely delivery.

Qualifications

• Advanced degree with 10+ years in biopharma analytics.
• Experience with drug substance (DS) and drug product (DP) release and stability testing.
• Ability to lead cross-functional teams and external partners.

Responsibilities

• Develop and implement robust analytical methods across the product lifecycle.
• Lead method qualification, validation, and transfer for DS/DP release and stability testing.
• Oversee GMP and non-GMP stability studies in alignment with regulatory requirements.
• Manage reference standard lifecycle for product registration and QC.
• Review QC data and documentation for release and stability testing.

Skills

Analytical method development

QC lifecycle management

Cross-functional leadership

Education

Bachelor's degree or higher in analytical chemistry/biochemistry

Job description

Uniquity Bio, a clinical-stage biotechnology company, seeks an Associate Director of Analytical Development & Quality Control in Malvern, PA. The role leads analytical development, QC, and regulatory submission activities, shaping strategy for late-stage development and BLA readiness.

The position requires strong protein chemistry knowledge, cross-functional influence, and ability to work with CMOs and contract labs while ensuring GMP compliance and timely delivery.