Principal Scientist, Biologics

Role Summary

Principal Scientist, Biologics role providing technical and analytical expertise for late-phase biologics process development and commercial manufacturing activities across multiple technology areas, managing projects with external CDMO partners, and collaborating cross-functionally to develop and execute clinical and commercial manufacturing.

Responsibilities

• Leads development projects for multiple technology areas (e.g., cell banking, cell culture, purification, formulation, or bioconjugation) to produce clinical and/or commercial drug substance, including process knowledge, technology transfer, analytical method transfer, design space and/or control strategy definition, optimization, and/or validation.
• Authors, reviews, and approves external manufacturing operation documents (SOPs, batch records, protocols, reports) for the production of clinical and/or commercial drug substance.
• Ensures compliance across technology areas through document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system.
• Authors and/or reviews source documents and CMC content to support IND, NDA, BLA and similar regulatory applications, including comparability and risk-based justifications.
• Leads collaborations with external partners such as CDMOs to develop selection criteria, assess capabilities, coordinate activities, plan technology transfer/analytical method transfer, troubleshoot, conduct risk assessments, and manage timely deliverables.
• Contributes to commercialization experience across programs, including optimization, process characterization, robustness, reproducibility, and process validation (definition/lock, PPQ, CPV).
• Mentors Senior Scientists and other staff on technical topics and Telix values.

Qualifications

• Education: BS with 11+ years of relevant experience, MS with 9+ years, or PhD with 8+ years in science or engineering.
• Experience: 6+ years in GMP, quality management system, and CMC compliance and regulation.
• Demonstrated experience in project management and ability to work in cross-functional, virtual teams.
• Travel: 10 ‚Äì 25% for in-person meetings, partner site visits, and SME/technical person-in-plant assignments.

Skills

• Strong collaboration and communication skills to interact with cross-functional teams and external partners.
• Technical proficiency across multiple biologics development areas (cell banking, cell culture, purification, formulation, bioconjugation).
• Analytical thinking, problem solving, and ability to manage multiple projects concurrently.

Education

• Science or engineering degree (BS/MS/PhD) with extensive relevant experience as specified.

Additional Requirements

• Travel up to 25% as needed for key meetings and partner site activities.