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CMC Program Lead at Telix Pharmaceuticals - ApplyBlast

CMC Program Lead

Telix Pharmaceuticals

5 months ago

3.6 on Glassdoor

Canada

Hybrid

Full Time

Senior

1 applicant

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About this role

The CMC Program Lead is responsible for leading the CMC Sub-Team and serving as the single point of contact for all CMC topics on the program matrix for early-stage antibody-conjugate radiopharmaceutical drug candidates. The CMC Lead will develop, execute, and maintain the integrated CMC strategy and plan grounded in Quality by Design (QbD) principles, aligned to Stage-Gate requirements, spanning Drug Substance, Drug Product, Analytical Development, and Supply Chain from preclinical development through end of phase 1 (first-in-human).

Responsibilities

Develop, own, and execute CMC strategies for antibody-based radiopharmaceutical drug candidates across the portfolio
Serve as the single point of accountability and key point of contact for all CMC matters within the program matrix
Lead the CMC Sub-Team for assigned programs, coordinating functional SMEs across Drug Substance, Drug Product, Analytical Development, QC, QA, Supply Chain, Validation, and Regulatory CMC
Own and maintain the integrated CMC plan, risk register, decision log, and project dashboards for assigned programs
Track CMC deliverables across multiple concurrent targets, maintain relationships with internal and external partners, and ensure CMC timelines are integrated with overall program plans

Skills

Qualifications

BS in Science, Mathematics, Engineering, or related discipline10+ years of CMC experience with 5+ years of CMC program/project management experienceExperience with biologics (monoclonal antibodies, bioconjugates) and/or radiopharmaceuticalsExperience managing pharmaceutical alliance/partnership programs or multi-site CMC executionKnowledge of FDA and global regulatory requirements (IND, NDA/BLA) applicable to radiopharmaceuticals and biologics

About Telix Pharmaceuticals

telixpharma.com

Headquarters

North Melbourne, Victoria, Australia

Company Size

201-500 employees

Founded

2015

View Profile

Telix Pharmaceuticals is a global, commercial‑stage biopharmaceutical company developing diagnostic and therapeutic “theranostic” products that use targeted radiation to detect and treat cancer. It advances radiopharmaceuticals through clinical development, regulatory approval, manufacturing and commercialisation to bring imaging agents and targeted therapies to patients. Telix works with the nuclear medicine community and international partners to scale access and improve outcomes. Its stated mission is to help patients with cancer live longer with better quality lives.