Associate Director, Manufacturing Development & Operations PM

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Full Time Malvern, PA, US

Uniquity Bio is a clinical-stage biotechnology company committed to putting science and patients first. We exist to develop transformative new medicines for immune-mediated diseases, and we’re looking for bright-minded professionals driven by a desire to advance science and make a difference for people in need. Our lead asset, solrikitug, is a highly potent TSLP inhibitor now in Phase 2 clinical trials for asthma, chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis (EoE) indications.

Join us in building an organization where people and science thrive together. You’ll have the opportunity to make a meaningful impact while working alongside a talented, agile team in an environment where ideas move quickly, colleagues are trusted, and quality remains a cornerstone.

The Associate Director, Manufacturing Development and Operations Project Management is responsible for leading cross-functional Chemistry, Manufacturing, and Controls (CMC) project management activities supporting the development, manufacture, and lifecycle management of monoclonal antibody therapeutics from early clinical development through commercialization. Reporting to the Sr. Director, Manufacturing Development and Operations Project Management (or equivalent), this role serves as a key partner to Technical Operations, Process Development, Analytical Development, Quality, Regulatory Affairs, Clinical Supply, and external manufacturing partners to ensure CMC programs are executed on schedule, within budget, and in compliance with quality and regulatory expectations.

The successful candidate will provide project leadership across drug substance and drug product development, technology transfer, manufacturing, analytical testing, regulatory submissions, and commercial readiness activities. This individual will drive planning, execution, risk management, communication, and decision-making across multiple internal and external stakeholders while establishing a culture of accountability, transparency, and operational excellence. Success in this role requires exceptional organizational and communication skills, strong technical understanding of biologics manufacturing and CMC development, and the ability to influence cross-functional teams without direct authority.

• Lead cross-functional CMC project management activities for monoclonal antibody development programs from preclinical development through commercialization.
• Partner with the Sr. Director, Manufacturing Development and Operations Project Management to provide overall project leadership and coordination, ensuring development activities are executed on schedule, within budget, and aligned with corporate objectives.
• Develop integrated CMC project plans that define scope, timelines, deliverables, critical paths, resource requirements, dependencies, and key milestones.
• Drive cross-functional alignment among Technical Operations, Process Development, Analytical Development, Manufacturing, Quality, Regulatory Affairs, Clinical Operations, Supply Chain, and Program Management.

• Coordinate manufacturing activities across drug substance and drug product development, including process development, technology transfer, GMP manufacturing, process characterization, process validation, analytical method readiness, release testing, and stability…