Director, Manufacturing Sciences - Drug Substance

Position Overview

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.

Key Responsibilities

• 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 investigations/deviations due to drug substance manufacturing activities to ensure phase appropriate quality and regulatory compliance.
• Support Process Characterization studies for drug substance from documentation review and protocol generation through study execution and completion of all associated reports. Must be proficient in Design of Experiments (DOE) and statistical analysis.
• Support Process Performance Qualification studies for drug substance from documentation review and protocol generation through study execution and completion of all associated reports. Must be proficient in Quality by Design principles.
• Partner with the CMC Project Management team to support project-level coordination, ensuring development programs are executed on time and within budget.
• Work with internal and external stakeholders to manage deliverables and budgets (e.g., CDMOs, vendors, and technical experts to support the planning and execution of drug substance process development and manufacturing activities. Participate in team meetings to identify project-level requirements and build collaborative relationships with other stakeholders including DS and DP Manufacturing, Process Development, Project Management, Quality Assurance, and Regulatory Affairs
• Author/Review/Edit appropriate sections of CMC regulatory documents including briefing book packages, regulatory amendments, BLA supporting documents, etc.
• Travel to company meetings, conferences, and CDMO sites as required (10%).

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.

Work Environment

At Uniquity Bio, we believe every team member has an impact on the patients we aim to serve. We are a nimble team with a rigorous approach to drug development that requires collaboration and transparency to maximize value, reduce risk, and deliver meaningful, best-in-class products. We are looking for self-starters who enjoy working in a complex, collaborative environment and are motivated to bring critical new medicines to people around the world. We are a small, fast-paced organization with a talented team of in-house employees and external consultants. Candidates must be self-motivated and able to work both independently and collaboratively to achieve success and impact in our dynamic work environment.

This is a U.S.-based position. Team members who live within commuting distance of our Malvern, PA or San Diego, CA office locations are expected to spend time in the office, and remote employees are expected to travel to an office on a regular basis. Specific details for both local and remote staff will be discussed and agreed upon on a case-by-case basis with the employee's manager. Business travel may be required depending upon the specific needs of the position.

The above job description is not intended to be all-inclusive. Requirements of the position may change from time to time based on business needs.