Director, Commercial CMC Programs

Telix Pharmaceuticals (AMER)

13d

About The Position

The Director, Commercial CMC Programs contributes to Telix’s commercial and strategic goals by developing manufacturing and operational plans for commercial and late-stage clinical assets in collaboration with Regional Operations leadership, Supply Chain, Program leadership, and the Director of Manufacturing Operations. The role oversees a team of CMC program leads and ensures CMC strategies are executed effectively through collaboration with internal and external partners. The CMC Programs team coordinates and delivers CMC activities for Precision Medicine Diagnostics and Therapeutics programs in line with project requirements and company goals. The position also establishes global production, supply chain, logistics, and distribution to support late-stage clinical progression and ongoing commercial manufacturing. The Director partners with external contract manufacturers and internal functions to oversee manufacturing, quality, and product development from mid-stage clinical through commercial manufacturing; manages contracts and budgets; develops manufacturing, capacity, cost-saving, and supplier strategies; and leads supplier performance reviews and issue resolution. The role also leads and develops Commercial CMC Program Leads, manages commercial manufacturing budgets and continuous improvement, and oversees external contract manufacturer metrics and operating mechanisms. Telix is a global radiopharmaceutical company focused on precision medicine for cancer and rare diseases. This role supports the international rollout of an approved prostate cancer imaging agent and the advancement of late clinical-stage products. The position requires approximately 30% domestic and international travel. Telix describes its workforce as hybrid and remote around the world and offers competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days, and learning and development support.

Requirements

BA or BS degree in Engineering, Biology, Chemistry, Business, or another relevant field.
10+ years of combined experience in cGMP Manufacturing, Contract Manufacturing, Business Development, or Quality.
Experience managing cross-functional teams, external partners, and CDMOs.
Experience managing cross-functional teams and international Contract Manufacturing Organizations.
Ability to travel approximately 30% domestically and internationally.
Commitment to excellence, results orientation, creativity and innovation, strong communication, collaboration, resilience, an inclusive mindset, adaptability, ethical behavior, and continuous learning.

Nice To Haves

Direct experience in Sterile Injectable Filling and Lyophilization of Drug Product/Substances supporting pre-commercial and commercial products.
Direct experience in Secondary Packaging of Parenteral drugs.
Direct experience in complex formulations of bulk drug substances and biologic drug substance manufacturing.

Responsibilities

Develop manufacturing and operational plans for commercial and late-stage clinical assets in collaboration with Regional Operations leadership, Supply Chain, Program leadership, and the Director of Manufacturing Operations.
Oversee a team of CMC program leads and ensure effective execution of CMC strategies through cross-functional collaboration with internal and external partners.
Coordinate and deliver CMC activities for Precision Medicine Diagnostics and Therapeutics programs in line with project requirements and company goals.
Establish global production, supply chain, logistics, and distribution to support late-stage clinical progression and ongoing commercial manufacturing.
Build and maintain effective relationships with contract manufacturers, serving as Telix’s liaison and escalation point for the External Contract Manufacturer network.
Oversee manufacturing, quality, and product development from mid-stage clinical through ongoing commercial manufacturing.
Manage contracts to meet company expectations and budget targets.
Partner with manufacturing and CMC leadership to sustain the ECM strategy internally and externally.
Work with the Director of Manufacturing Operations to develop cost-saving and capacity-management strategies within applicable ECMs.
Collaborate with Program leadership, Supply Chain, and CMC leadership to develop manufacturing and capacity strategies aligned with short- and long-term marketing strategies.
Establish, own, and manage key ECM operating mechanisms and oversight with Supply Chain and Procurement.
Coordinate communication among applicable internal and external functions and organizations.
Manage issues to achieve efficient and effective business resolutions.
Lead, develop, and performance-manage Commercial CMC Program Leads, including coaching employees to improve capabilities and contributions.
Lead performance business reviews with suppliers and contracting organizations.
Create and populate ECM metrics for scorecards and dashboards.
Manage the commercial manufacturing budget and implement continuous improvement.