Senior Manager, Document and Data Management

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.

Position Overview

Reporting to the Senior Director, Manufacturing Development and Operations Project Management, the Senior Manager, Document and Data Management is responsible for leading the management of technical documents and associated data that support process development, manufacturing, analytical testing, and other Chemistry, Manufacturing, and Controls (CMC) development activities for development-stage products within Uniquity Bio. The position ensures that development documentation and supporting data are accurately prepared, reviewed, approved, maintained, and archived in accordance with company procedures, regulatory expectations, and industry best practices.

Working in close partnership with the Senior Director, Manufacturing Development and Operations Project Management, this individual provides project-level coordination to support the timely execution of CMC development activities. The role serves as a central point of coordination for technical documentation generated by internal teams and external partners, including contract development and manufacturing organizations (CDMOs), contract laboratories, vendors, and consultants, ensuring that key development deliverables such as protocols, reports, stability data, technical summaries, and project documentation are complete, accurate, reviewed, approved, and readily accessible.

The Senior Manager partners closely with Manufacturing Development and Operations, Quality, Regulatory Affairs, and Program Management to facilitate document reviews, coordinate cross-functional activities, monitor document and data status, and support regulatory submissions and batch readiness activities. The position also helps establish and continuously improve scalable document and data management processes, standards, and tools that promote consistency, traceability, data integrity, transparency, and efficient execution across development programs.

Success in this role requires exceptional organizational and interpersonal skills, meticulous attention to detail, strong project coordination capabilities, and a passion for execution. The ideal candidate possesses a solid understanding of pharmaceutical development, manufacturing processes, CMC documentation, and technical data management, and thrives in a collaborative, fast-paced environment where timely, high-quality documentation is critical to program success.

Key Responsibilities

• Partner with the Senior Director, Manufacturing Development and Operations Project Management to provide strong project-level support and coordination to ensure timely execution of development activities.
• Work with internal and external stakeholders (e.g., CDMOs, vendors, and technical experts) to manage manufacturing project deliverables (e.g., protocols, reports, summary slide decks).
• Receive manufacturing-related documents (both internal and external) and effectively and efficiently post/route them for review using the established review procedure, monitor the review process, and follow-up with internal and external stakeholders to bring the documents to completion and to ensure that they are properly filed/archived.
• Lead and facilitate cross functional team meetings (including both internal and external partners) as needed to support the document review process.
• Monitor, track, and tabulate stability data for internal review as well as external submissions, including regulatory filings.
• Complete data verification activities as requested, including but not limited to, review of raw data files.
• Collaborate with several development functions including Manufacturing Development and Operations and Quality to support batch readiness and disposition activities.
• Curate project-specific correspondences including, but not limited to, reports, meeting slide decks, and analytical methods.
• Develop and maintain project-related documents and archive project materials to ensure visibility of project history, current status, and future directions.
• Leverage project management best practices and tools (e.g., trackers) to foster a team culture of transparency, accountability, effective cross-functional communication, and timely execution.

Qualifications

Education

• Bachelor's degree in Life Sciences, Engineering, Information Management, Technical Communications, or a related discipline required.

Experience

• 5 - 10 years of experience in document management, technical operations, CMC, regulatory operations, or a related function within the biotechnology or pharmaceutical industry.
• Experience managing technical development documentation supporting biologics or pharmaceutical product development.
• Experience with electronic document management systems (e.g., SharePoint, SmartSheet, etc.).
• Experience supporting regulatory submissions, including INDs, BLAs, or global marketing applications, is highly desirable.

Knowledge, Skills, and Abilities

• Strong understanding of document lifecycle management, version control, records management, and electronic document management systems.
• Familiarity with CMC development documentation and the documentation requirements supporting regulatory submissions.
• Excellent organizational skills with exceptional attention to detail and document quality.
• Strong project management skills with the ability to coordinate multiple concurrent document reviews and deadlines.
• Excellent written, verbal, and interpersonal communication skills.
• Ability to work effectively across Manufacturing Development and Operations, Quality, Regulatory Affairs, and Program Management organizations.
• Demonstrated ability to improve business processes and implement scalable document management practices in a growing organization.
• Proficiency with Microsoft Office and electronic document management systems.
• Experience supporting organizations progressing from early development through commercialization is preferred.

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.

Uniquity Bio is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.