Jobs at Terrestrial Bio, Inc.

Supports quality assurance for combination medical products, focusing on device design controls, risk management, cGMP compliance, process validation, supplier quality, and batch record review. Maintains QMS documentation, DHFs, risk analyses, SOPs, protocols, and reports; participates in MRB, CAPA, deviations, audits, and regulatory inspection readiness. Collaborates with Manufacturing, Process Development, Quality Control, and Material Management during early clinical development.

Leads the Process Analytical Technology function for a microneedle array patch manufacturing program. Owns PAT strategy, technology evaluation, method development and validation, chemometric modeling, control strategy, SPC integration, data infrastructure, and transition to real-time release testing. Partners with manufacturing, process development, and formulation teams; supports regulatory submissions and inspections; oversees CSV and data integrity under GAMP 5; and builds the PAT organization toward commercialization.

Provides hands-on QA oversight for GMP manufacturing, packaging, QC testing, materials, equipment, and facilities. Reviews batch records, analytical data, protocols, and reports for accuracy, data integrity, and compliance. Supports inspections, deviations, OOS/OOT investigations, CAPA, change controls, validation activities, batch disposition, material inspection, equipment qualification, and facility readiness. Collaborates cross-functionally to resolve quality issues and maintain inspection readiness in a combination product environment.

Leads Terrestrial Bio’s enterprise Data & AI strategy, infrastructure, governance, ontology, systems integration, and applied AI roadmap. Builds and manages the Data & AI team, selects MES, ERP, LIMS, ELN, and QMS systems, oversees data pipelines and agentic automations, and ensures GxP-compliant data integrity, auditability, privacy, and change control. Reports to the CEO and communicates strategy, risks, progress, and investment plans to executive leadership and the Board.

Establish and lead Terrestrial Bio’s in-house GMP microbiology laboratory supporting its microneedle array patch program. Responsibilities include building Bioburden, bacterial endotoxin, and environmental monitoring capabilities; qualifying equipment; validating and transferring methods; authoring GMP documentation; managing investigations and CAPA; supporting contamination control and regulatory inspections; and hiring and mentoring microbiology staff.

The Senior Director of IT will build and lead Terrestrial Bio’s IT function from the ground up. Responsibilities include defining IT strategy and architecture, selecting and managing infrastructure, cloud, ERP, SaaS, networking, and security systems, hiring the IT team, executing multi-site transitions, establishing GxP-compliant governance and data integrity controls, and managing budgets, vendors, and contracts. The role partners with Manufacturing, Quality, Finance, and Operations while preparing IT infrastructure for rapid growth and headquarters consolidation.

Develops, characterizes, and improves manufacturing processes for therapeutic microarray patches. Designs and analyzes process development experiments, supports equipment and process scale-up, implements improvements in GMP manufacturing operations, updates batch records and SOPs, contributes to the quality system, and mentors junior engineers and technicians. Collaborates cross-functionally to advance products through clinical development and establish high-throughput commercial manufacturing capabilities.

Leads development and scale-up of microarray patch manufacturing processes for biopharmaceutical combination products. Responsibilities include modeling process parameters and quality attributes, designing experiments, improving unit operations, assessing automated equipment and analytical technologies, supporting GMP technical operations and regulatory filings, and managing engineers and technicians. The role establishes lab and pilot-scale processes, develops operating ranges, leads technology transfers, and mentors technical staff.

Develop and optimize cell-based functional bioassays for preclinical research and GMP lot release testing involving proteins, antibodies, peptides, and RNA. Execute compliant testing, analyze data statistically, maintain laboratory records, prepare reports for regulatory filings, and contribute to study design and translational research supporting IND submissions.