Director, Drug Substance Manufacturing Sciences

ADP; Malvern (Chester County); On-site; USD 180,000 - 320,000; Full time

Job summary

Uniquity Bio's Director, Manufacturing Sciences – Drug Substance is a senior role leading manufacturing for a monoclonal antibody program. Based in Malvern, PA, the role collaborates with CDMOs/CROs and internal teams to develop and scale drug substance processes from early development through regulatory submissions and commercial readiness.

The candidate will oversee process development, technology transfer, DOE/statistical analyses, and CMC document authoring, while managing timelines and

Qualifications

• B.S., M.S., and/or Ph.D. in Engineering, Biochemistry, Molecular Biology, or a related discipline.
• Proven experience (7+ years) in process development and manufacturing for protein therapeutics (monoclonal antibodies, specifically).
• Experience in overseeing and leading early to late development drug substance manufacturing activities for protein therapeutics.
• Demonstrated ability to oversee, manage and direct the work of consultants, external collaborators and CDMOs / CROs / CTLs.
• Extensive hands‑on experience with manufacturing unit operations pertinent to monoclonal antibodies and other protein therapeutics, particularly in downstream operations.
• Experience with technology transfer and scale up activities, and a track record of successful collaboration with internal and external (CDMO/CRO) teams.
• Experience reviewing release data packages.
• Thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing process development, manufacturing, and stability.
• Experience with authoring regulatory submissions such as INDs, BLAs, etc.
• Strong leadership and project management skills, with the ability to effectively prioritize tasks, manage timelines, and drive results.
• Exceptional written, oral, interpersonal, and presentation skills and the ability to effectively interface with colleagues throughout the organization, including management team.
• Proven ability to adapt to a dynamic and fast‑paced work environment.

Responsibilities

• Review/edit/update process documentation to ensure drug substance manufacturing process performance and product quality.
• Monitor manufacturing activities including tech transfer, data trending, change controls, etc.
• Support CDMO investigations/deviations to ensure quality and regulatory compliance.
• Support DOE studies from review to completion; proficient in DOE and statistical analysis.
• Support Process Qualification studies for drug substance; proficient in Quality by Design principles.
• Partner with CMC Project Management to ensure programs are on time and within budget.
• Work with CDMOs, vendors, and experts to plan and execute development and manufacturing activities.
• Author/Review/Edit CMC regulatory documents such as briefing books and BLA submissions.
• Travel to meetings, conferences, and CDMO sites as required (10%).

Skills

Process development

Monoclonal antibodies

CDMO management

Regulatory submissions

Project management

Team leadership

Scale-up

DOE

GMP

Education

Engineering, Biochemistry, Molecular Biology

Job description

Uniquity Bio's Director, Manufacturing Sciences – Drug Substance is a senior role leading manufacturing for a monoclonal antibody program. Based in Malvern, PA, the role collaborates with CDMOs/CROs and internal teams to develop and scale drug substance processes from early development through regulatory submissions and commercial readiness.

The candidate will oversee process development, technology transfer, DOE/statistical analyses, and CMC document authoring, while managing timelines and