Director, Drug Substance Manufacturing Excellence

Uniquity Bio, Inc.; San Diego (CA); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Uniquity Bio is seeking a Director of Manufacturing Sciences – Drug Substance to lead drug substance manufacturing for a monoclonal antibody program. You will coordinate CDMO/CRO/CTL activities, align CMC objectives with development plans, and manage budgets and timelines across development through regulatory submissions and commercial launch.

The role requires strong technical knowledge of biologics manufacturing, DOE and QbD expertise, and exceptional cross-functional leadership as part of the

Qualifications

• 7+ years in process development and manufacturing for protein therapeutics (monoclonal antibodies).
• Experience leading early to late development drug substance manufacturing activities.
• Experience with technology transfer and scale up.
• Thorough understanding of ICH, FDA, and EMA GMP requirements.
• Experience with authoring regulatory submissions (INDs, BLAs, etc).

Responsibilities

• Review/update process documentation to ensure drug substance manufacturing performance and quality.
• Monitor manufacturing activities including tech transfer, data trending, and change controls.
• Support CDMO investigations/deviations to ensure quality and regulatory compliance.
• Perform DOE studies and statistical analysis for process characterization.
• Support QbD principles in process qualification and regulatory submissions.
• Coordinate with CMC Project Management for on-time, on-budget execution.

Skills

Leadership

Project management

DOE

QbD

Cross-functional

Communication

Education

BS/MS/PhD in Engineering/Biochemistry/Molecular Biology

Job description

Uniquity Bio is seeking a Director of Manufacturing Sciences – Drug Substance to lead drug substance manufacturing for a monoclonal antibody program. You will coordinate CDMO/CRO/CTL activities, align CMC objectives with development plans, and manage budgets and timelines across development through regulatory submissions and commercial launch.

The role requires strong technical knowledge of biologics manufacturing, DOE and QbD expertise, and exceptional cross-functional leadership as part of the