BrainChild Bio

Research Analyst

• Work collaboratively with internal Process Development and Analytical Development teams.
• Assist with experimental execution in support of molecular assay development and qualification, including ddPCR/qPCR-based methods.
• Perform routine molecular analytics (e.g., ddPCR) and provide data in a timely manner to support process studies.
• Support development and execution of lentiviral vector characterization assays for process development and process characterization activities.
• Author ELNs, methods, reports and SOPs.

Senior Research Associate – Analytical Development

Compliance

• Lead all operational and lifecycle management aspects of Regulatory CMC submissions (e.g., INDs, IMPDs, BLAs, MAAs, variations, amendments) supporting cell therapy development programs.
• Develop and execute global regulatory CMC strategies that align with program objectives, regulatory requirements, and overall business strategy.
• Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development and lifecycle management.
• Author, review, and coordinate Module 3 (M3) content, ensuring consistency, quality, and alignment across global regulatory submissions (e.g., US, EU, and other international health authorities).
• Evaluate the regulatory impact of CMC changes through formal change control processes and define and execute appropriate filing strategies.
• Proactively identify CMC regulatory risks, anticipate Health Authority questions, and develop mitigation and contingency strategies to support successful outcomes.
• Lead or contribute to interactions with health authorities by preparing briefing packages, technical justifications, responses to information requests, and regulatory meeting support.
• Collaborate cross‑functionally to ensure CMC deliverables meet regulatory requirements, quality standards, and program timelines.
• Drive continuous improvement and best‑practice sharing for Regulatory CMC processes in a rapidly growing, dynamic environment.

Senior Research Associate – Analytical Development

Director, Regulatory Affairs, CMC