Senior Scientist, Biologics

Telix Pharmaceuticals Limited

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

Posted 11/10/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates technical and analytical expertise in biologics process development and manufacturing, with a strong focus on compliance, project management, and cross-functional collaboration. Proficient in authoring and reviewing regulatory documents and ensuring adherence to GMP and CMC standards.

Highest-signal resume keywords

Biologics Process DevelopmentGMP ComplianceProject ManagementCross-Functional CollaborationRegulatory Documentation

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Applicant Tracking System Keywords

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Hard Skills

Process KnowledgeTechnology TransferAnalytical Method TransferControl Strategy DefinitionOptimizationValidationQuality InvestigationsChange ControlRisk AssessmentBiologics Technology Expertise

Soft Skills

CommunicationTeamworkProblem-SolvingAnalytical ThinkingAdaptability

Tools & Technologies

Quality Management SystemSOPsBatch RecordsProtocolsReports

Industry Keywords

CMC ComplianceINDNDABLACell BankingCell CulturePurificationFormulationBioconjugation

About the role

Key responsibilities & impact

Provide technical and analytical expertise for late-phase biologics process development and manufacturing activities
Manage projects in a specific technology area at external CDMO partners
Contribute to internal cross-functional collaborations for clinical and/or commercial manufacturing
Design and document development projects, including process knowledge, technology transfer, analytical method transfer, design space, control strategy definition, optimization, and validation
Author, review, and approve external manufacturing documents, including SOPs, batch records, protocols, and reports
Ensure compliance through document creation, review and approval, quality investigations, corrective actions, and change control within a Quality system
Author and/or review source documents and CMC content supporting IND, NDA, BLA, and similar regulatory applications
Collaborate with CDMOs to assess capabilities, coordinate activities, troubleshoot, analyze operational performance, conduct risk assessments, and ensure timely deliverables

Requirements

What you’ll need

Science or engineering degree with minimum relevant experience: BS with 8 years of experience, MS with 6 years of experience, or PhD with 5 years of experience
Minimum 5 years of experience in GMP, quality management system, and CMC compliance and regulation
Demonstrated understanding and application of project management principles and tools
Ability to work in cross-functional, virtual teams
Technical and analytical expertise in a specific biologics technology area, such as cell banking, cell culture, purification, formulation, or bioconjugation
Ability to communicate with cross-functional teams in formal settings and third-party meetings
Ability to identify risks and needed deliverables and manage workload with limited feedback
Travel expectation of 10–25% for key in-person meetings, partner site visits, and SME/technical person-in-plant assignments

Benefits

Comp & perks

Annual performance-based bonuses
Equity-based incentive program
Generous vacation
Paid wellness days
Support for learning and development
Hybrid and remote work arrangements are available across Telix
Supportive, engaged global interdisciplinary team