CMC Program Lead

Telix Pharmaceuticals Limited

. Lead the CMC Sub-Team and serve as the single point of contact for all CMC topics for the TLX597 and TLX66 program .

Posted 10/27/2026full-timeRemote • United States, Belgium, Canada, Switzerland, United KingdomSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in CMC program management, including the development and execution of integrated strategies for radiopharmaceuticals and biologics. Proficient in managing cross-functional teams and ensuring compliance with FDA and global regulatory requirements throughout the drug development lifecycle.

Highest-signal resume keywords

CMC Program ManagementRegulatory ComplianceProject ManagementBiologics ExperienceRisk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Strategy DevelopmentDrug Substance ManagementAnalytical DevelopmentQuality ControlQuality AssuranceBioconjugationAntibody ManufacturingUpstream ProcessingDownstream ProcessingIND/NDA/BLA Requirements

Soft Skills

InitiativeProcess ImprovementCollaborationAdaptabilityCommunication

Tools & Technologies

Project DashboardsRisk RegistersDecision LogsTask ListsSOPs

Industry Keywords

RadiopharmaceuticalsPharmaceuticalsBiopharmaMatrix Operating ModelICH Q8-Q12 GuidelinesQuality by DesignClinical Supply WorkstreamsTechnology TransferPhase-Transition HandoffsDrug Development Lifecycle

About the role

Key responsibilities & impact

Lead the CMC Sub-Team and serve as the single point of contact for all CMC topics for the TLX597 and TLX66 program
Develop, execute, and maintain integrated CMC strategies and plans from preclinical development through Phase 3
Coordinate functional SMEs across Drug Substance, Drug Product, Analytical Development, QC, QA, Supply Chain, Validation, and Regulatory CMC
Own CMC deliverables, timelines, budgets, risk registers, decision logs, project dashboards, and Gate-readiness packages
Track deliverables across concurrent targets and manage internal and external partner relationships, contracts, budgets, and invoices
Identify CMC risks, develop mitigation strategies, and escalate issues early
Provide regular CMC updates to senior management and program governance
Coordinate with manufacturing sites and external CDMOs/CMOs for Drug Substance and Drug Product supply
Partner with R&D, Discovery, Translational Development, Radiochemistry, Regulatory, Quality, Supply Chain, and collaboration partners
Support CMC IND packages, clinical supply workstreams, technology transfer packages, and phase-transition handoffs
Facilitate meetings and maintain agendas, minutes, decision logs, task lists, and risk analyses
Identify process gaps and implement solutions in accordance with SOPs and applicable GxP requirements

Requirements

What you’ll need

BA or BS degree in Science, Mathematics, Engineering, or a related scientific discipline required
10+ years of relevant radiopharmaceutical, pharmaceutical, or biopharma CMC experience
5+ years of CMC program/project management experience
Experience with biologics, monoclonal antibodies, bioconjugates, and/or radiopharmaceuticals required
Experience managing pharmaceutical alliance/partnership programs or multi-site CMC execution within a matrix operating model
Robust knowledge of FDA and global regulatory requirements, including IND and NDA/BLA requirements applicable to radiopharmaceuticals and biologics
Technical understanding of antibody manufacturing, upstream/downstream processing, bioconjugation, radiochemistry, and drug product fill/finish
Familiarity with ICH Q8-Q12 guidelines and Quality by Design principles, including TPPs, CQAs, CPPs, and control strategy development
Strong experience in project management across the drug development lifecycle
Experience working in a successful matrix-managed environment
Ability to demonstrate initiative and improve or establish processes
Ability to work in a dynamic, fast-paced, continuously changing global environment with minimal oversight
Ability to travel minimally to manage collaborations with global team members and CDMOs

Benefits

Comp & perks

Annual performance-based bonuses
Equity-based incentive program
Generous vacation
Paid wellness days
Support for learning and development
Competitive salary
Hybrid and remote work arrangements