Principal Scientist, Biologics

Telix Pharmaceuticals Limited

. Provide technical and analytical expertise for early-phase biologics process development and manufacturing activities .

Posted 10/12/2026full-timeRemote • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in biologics process development and manufacturing, with a strong focus on project management, regulatory compliance, and cross-functional collaboration. Proficient in leading technical projects and mentoring teams while ensuring adherence to quality systems and regulatory standards.

Highest-signal resume keywords

Biologics Process DevelopmentGMP ComplianceProject ManagementRegulatory Applications (IND, NDA, BLA)Cross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical Method TransferPurification TechnologyFormulation TechnologyBioconjugation TechnologyControl Strategy DefinitionQuality InvestigationsChange ControlSOP Review and ApprovalTechnical Knowledge in BiologicsDocument Creation and Review

Soft Skills

Communication with Cross-Functional TeamsMentoringAutonomous Work Management

Industry Keywords

Quality Management SystemCMC ComplianceTherapeutic ProgramRisk AssessmentsCapability AssessmentClinical Manufacturing

About the role

Key responsibilities & impact

Provide technical and analytical expertise for early-phase biologics process development and manufacturing activities
Manage projects across analytical, purification, formulation, and bioconjugation technology areas
Act as the Biologics lead for a specific therapeutic program
Lead development projects involving process knowledge, technology transfer, analytical method transfer, design space, control strategy definition, optimization, and qualification
Review and approve SOPs, batch records, protocols, analytical procedures, and development reports
Ensure compliance through document creation, review and approval, quality investigations, corrective actions, and change control within a Quality system
Author and review source documents and CMC content for IND, NDA, BLA, and similar regulatory applications
Lead collaborations with internal sites and external CMC partners, including capability assessment, activity coordination, planning, troubleshooting, risk assessments, and deliverable management
Mentor Senior Scientists and other Scientists on technical topics and Telix values
Contribute to cross-functional collaborations to develop and execute clinical manufacturing

Requirements

What you’ll need

Science or engineering degree with one of the following experience combinations: BS with 11 years of experience, MS with 9 years of experience, or PhD with 8 years of experience
Minimum 5 years of experience in GMP, quality management system, and CMC compliance
Demonstrated understanding and application of project management principles
Ability to work in cross-functional, virtual teams
Technical knowledge in multiple biologics technology areas, including analytical, purification, formulation, or bioconjugation
Ability to communicate with cross-functional teams in formal settings and third-party meetings
Ability to manage workload autonomously, with feedback for complicated topics
Willingness to travel 10–25% for key in-person meetings, partner site visits, and SME/technical person-in-plant
Experience supporting regulatory applications such as IND, NDA, and BLA, including comparability and risk-based approaches

Benefits

Comp & perks

Annual performance-based bonuses
Equity-based incentive program
Generous vacation
Paid wellness days
Support for learning and development
Remote work arrangement