Director, Manufacturing Sciences - Drug Substance

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Full Time Malvern, PA, US

5 days ago Requisition

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 Director, Manufacturing Sciences – Drug Substance will play a key role in leading and driving activities for drug substance manufacturing of biological drug candidates at Uniquity’s CDMOs / CROs / CTL (control testing laboratories). The successful candidate will be part of the Manufacturing Development & Operations team, serving as a key technical and CMC team member. The initial program is a monoclonal antibody being developed as a subcutaneous injectable therapeutic for several chronic inflammatory diseases.

The selected candidate will coordinate drug substance manufacturing activities and serve as a key member of the product development team. This position will receive strategic direction from the VP, Drug Substance Process Development and Manufacturing and will work closely with the Manufacturing Technical Operations team to ensure continuous alignment of the CMC objectives with overall product development plans.

The selected candidate will contribute to overall plans, including timelines and budgets, for all drug substance manufacturing activities from early development through regulatory submissions and commercial launch. The individual in this role will also be responsible for coordinating the delivery of accurate reports and regulatory submission components related to these activities.

To achieve optimal and timely execution of drug substance manufacturing activities, the selected candidate will consistently work cross-functionally to identify short and long-term project requirements. In partnership with functional area leaders, the selected candidate will ensure effective stakeholder management and communication related to drug substance manufacturing activities.

Success in this role depends on a strong technical knowledge of the drug substance manufacturing process, excellent organizational and interpersonal skills, a keen attention to detail, and a passion for project execution. This role is expected to contribute to Uniquity’s continual drive to cultivate and maintain a passionate culture, dedicated to rapidly developing its portfolio while demonstrating the highest standards of ethics and professionalism.

• Review/edit/update process documentation including process specifications, master batch records, etc. to ensure expected drug substance manufacturing process performance and product quality following appropriate best practices.
• Monitor manufacturing activities including tech transfer, data trending, change controls, etc. to ensure expected drug substance process performance and product quality. May include Person-In-Plant participation.
• Support CDMO…