[Hiring] Director, Manufacturing Operations @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
• Directors of CMC Programs

Ensuring their effective leadership, execution, and delivery through the delivery of process development and improvement required for contract and regulatory compliance as well as commercial viability by ensuring adequate global production, supply chain, logistics, and distribution planning to support current clinical development and commercial development of the Group’s assets.

This role oversees subject matter experts in Small Molecule API, Aseptic Fill/Finish, and Secondary Packaging activities with a focus on execution to company objectives with the level of quality needed per stage.

Key Accountabilities:

• Partner with contract manufacturers to ensure quality, deliveries, and costs meet or exceed Telix’s expectations.
• Provide oversight into the manufacturing, quality, and development of products from mid-stage clinical through commercial launch.
• Partner with the Directors of CMC Programs to sustain, monitor, and improve both internal and external contract development/manufacturing organization (CDMO) strategies.
• Partner with the Directors of CMC Programs to determine strategies for cost savings, supply redundancy, and process improvement within CDMO network.
• 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).
• Manage complex technical issues to ensure efficient and effective business resolution.
• Support quality investigations and non-conformances by providing appropriate product expertise.
• Leadership, development, and performance management of the team of manufacturing engineers for the purpose of driving team capabilities to surpass company goals, including employing initiatives to coach employees to optimize their contribution and outputs.
• Technical lead for business reviews with suppliers/contracting organizations.
• Oversee technical transfers and process validation at internal and external CDMOs.

Qualifications

• BA or BS degree in Engineering, Biology, Chemistry, or other relevant field
• 10+ years combined experience in late-stage clinical to commercial cGMP Manufacturing, Engineering, Contract Manufacturing, and/or Quality
• 3+ years of previous management experience
• Direct experience in Sterile Injectable Filling and Lyophilization of Drug Product/Substances supporting both clinical and commercial products
• 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 working with 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