Senior Leader, Analytical Development & QC (Biologics)

Uniquity Bio, Inc.; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Uniquity Bio in Malvern, PA, seeks an Associate Director of Analytical Development & Quality Control to lead analytical development, method qualification, transfer, validation, and release testing for drug substance and product. The role ensures GMP compliance and readiness for regulatory submissions.

The position provides scientific leadership across analytical development and QC, guiding cross‑functional teams and coordinating with CMOs and contract labs to drive lifecycle management through

Qualifications

• Bachelor's or higher in analytical chemistry, biochemistry, or related field.
• 10+ years in biopharmaceutical analytical development/quality control.
• Strong knowledge of protein chemistry, analytical methods, and bioassays.
• Experience with biologics analytical method development, qualification, transfer, validation, and lifecycle management.

Responsibilities

• Lead analytical development, method qualification, transfer, validation, and lifecycle management for DS/DP release and stability testing.
• Ensure GMP/GLP compliance and regulatory readiness for CMC submissions (PPQ, BLA).
• Provide scientific leadership and cross-functional collaboration with internal teams and external partners (CMOs/labs).
• Drive risk management, data integrity, and technical documentation quality.

Skills

Analytical chemistry

Biochemistry

Analytical method development

Leadership

Education

Bachelor's degree or higher in analytical chemistry/biochemistry or related field

Job description

Uniquity Bio in Malvern, PA, seeks an Associate Director of Analytical Development & Quality Control to lead analytical development, method qualification, transfer, validation, and release testing for drug substance and product. The role ensures GMP compliance and readiness for regulatory submissions.

The position provides scientific leadership across analytical development and QC, guiding cross‑functional teams and coordinating with CMOs and contract labs to drive lifecycle management through