Director, Commercial CMC Programs

Telix Pharmaceuticals (AMER)

5d•Hybrid

About The Position

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. To contribute to the achievement of the Group’s commercial and strategic goals by developing manufacturing and operational plans for the Group’s commercial and late-stage clinical assets in collaboration with Regional Operations leadership, Supply Chain, Program leadership, and the Director of Manufacturing Operations. As the Director, CMC Programs, you will play a critical role in overseeing a team of CMC program leads. Ensuring the effective execution of CMC strategies through the cross functional collaboration of internal and external partners. The CMC Programs team will be responsible for coordinating and delivering CMC activities in line with project requirements and company goals for Precision Medicine Diagnostics and Therapeutics programs. Setting up and solidifying global production, supply chain, logistics and distribution to support current late-phase clinical progression into commercial and ongoing commercial manufacturing of the Group’s assets.

Requirements

BA or BS degree in Engineering, Biology, Chemistry, Business or other relevant field
10+ years combined experience in cGMP Manufacturing, Contract Manufacturing, Business Development, or Quality
Experience in managing cross-functional teams, external partners, and CDMOs required
Ability to travel approximately 30% - both domestically and internationally

Nice To Haves

Direct experience in Sterile Injectable Filling and Lyophilization of Drug Product/Substances supporting both pre-commercial and commercial products preferred
Direct experience in Secondary Packaging of Parenteral drugs preferred
Direct experience in complex formulations of bulk drug substances and biologic drug substance manufacturing preferred
Experience managing cross-functional teams and International Contract Manufacturing Organizations

Responsibilities

Partner with contract manufacturers to create and maintain effective relationships. Serve as the liaison and escalation point between Telix and the External Contract Manufacturer (ECM) network
Provide oversight of the manufacturing, quality, and development of products from mid-stage clinical through ongoing commercial manufacturing.
Manage contracts to ensure delivery of company expectations while meeting budget targets
Partner with the Directors of Manufacturing Operations, Biologics, Radiochemistry, and CMC Programs to sustain ECM strategy used internally and externally
Partner with the Director of Manufacturing Operations to determine strategies for cost savings and capacity management within applicable ECMs
Partner with Program leadership, Supply Chain, and the Directors of CMC Programs to develop manufacturing and capacity strategies consistent with the current and future marketing strategies (short- and long-term)
Establish, own, and manage key ECM operating mechanisms and oversight alongside Supply Chain and Procurement
Coordinate communication between all applicable internal and external functions/organizations
Manage issues to ensure efficient and effective business resolution
Leadership, development, and performance management of the Commercial CMC Program Leads for the purpose of driving team capabilities to surpass company goals, including employing initiatives to coach employees to optimize their contribution and outputs
Lead performance business reviews with suppliers/contracting organizations
Responsible for ECM metrics for scorecard/dashboard creation and population
Commercial manufacturing budget management, including implementing continuous improvement