[Hiring] Director, Commercial CMC Programs @AMER

Role Description

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
• 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.

Key Accountabilities:

• 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.
• 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.

Qualifications

• 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.
• 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.
• Ability to travel approximately 30% - both domestically and internationally.

Key Capabilities

• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do.
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results.
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges.
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language.
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals.
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges.
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected.
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges.
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders.
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills.