Sr. Director, Operations TMS Expansion

See Yourself at Telix

The Sr Director TMS Operations will oversee the operational aspects of future expansion projects led by TMS including expansion of current capabilities and capacity at current TMS facilities as well as future expansion plans and projects. This position is expected to build strong collaborative relationships with other key leaders in the organization (specifically the VP of CDMO Expansion) ensuring that Telixs manufacturing facilities are positioned to optimize performance in terms of manufacturing quality service and consistency of radio-pharmaceutical production. The position reports directly to the SVP TMS Global Operations.

Key Accountabilities:

• Global position focused on TMS expansion capabilities and capacity (existing and future).
• Provides operational services support to regional TMS team focused on optimizing current TMS capabilities (Supports TMS Strategy Pillar 1):
  • Accelerate Seneffe operational capabilities:
    • TLX591 Tx for ProstAct Global and Commercial Manufacturing
  • Prioritize and accelerate Yokohama operational capabilities
    • Zircaix CT and Commercial Manufacturing
    • TLX591 Tx for ProstAct Global and Commercial Manufacturing in Japan
  • Deliver future TMS capabilities
• Provides operational support for the development and operationalization of Project Lightning (2 Tx sites) (Supports TMS Strategy Pillar 2).
  • Same as below.
• Provides operational support for the development and operationalization of RLS expansion sites (x 6 sites) (Supports TMS Strategy Pillar 3). Ex:
  • Equipment Selection:
    • Cyclotron capabilities cost and lead time evaluation.
    • URS for manufacturing equipment.
    • Hot Cell capabilities cost and lead time evaluation (per URS).
    • URS creation sourcing of analytical equipment manufacturing software quality system software inventory management software IT systems.
    • Service maintenance and warranties.
    • Lab and manufacturing equipment sourcing (per URS).
    • Vendor onboarding and equipment purchase.
  • Facility Design & Build:
    • Site Requirement Planning.
    • Design Build team sourcing and contracting.
    • Site Design Requirement Planning.
    • SME to complete design package per stage (10%-30%-100%).
    • Site Construction Planning.
    • GC contracting (contract review and executed).
  • Provide user requirements to support PET212 GMP manufacturing lab (workflow manufacturing QC dispensing areas) RAM and FDA manufacturing requirements.
• Operational support for the development of a Phase 3/Commercial capabilities at ITG (Building 4) (Supports TMS Strategy Pillar 4).
  • Operational support for process and (SOP) creation which includes (part of cross functional team):
    • Workflow maps to support design; Master Formula for each product; Batch Record for each product
    • Quality Systems: Document Controls; Deviations; Investigations; Batch Release; Operator Qualifications; Media Fills; Sterility Testing; Environmental Monitoring Program
    • Equipment maintenance; Facility maintenance
    • Inventory management
    • Emergency response
  • Collaborate with other departments including manufacturing quality assurance regulatory affairs and supply chain to ensure seamless coordination and alignment of facility expansions with organizational objectives.

Education and Experience:

• Minimum of 10 years of operational experience preferably in the pharmaceutical or biotechnology industry (radiopharmaceuticals preferred).
• Strong knowledge of regulatory requirements and industry standards related to pharmaceutical manufacturing facilities including FDA regulations BOP regulation cGMP guidelines NRC regulations and environmental health and safety standards.
• Excellent leadership and interpersonal skills with the ability to effectively communicate and collaborate with cross-functional teams and external stakeholders.
• Demonstrated experience in strategic planning budget management and vendor negotiations.
• Proficiency in facility management software systems and tools for asset management maintenance planning and performance tracking.
• Strong analytical and problem-solving skills with the ability to identify issues develop solutions and drive continuous improvement initiatives.
• Location: Remote with frequent travel to various TMS manufacturing facilities

Personal Attributes / Competencies:

• Strong interpersonal organizational and managerial skills.
• Excellent verbal and written skills communication skills are required.
• Excellent attention to detail in the execution of job responsibilities.
• Positive attitude with excellent interpersonal skills with a proven ability to create and maintain strong working relationships with internal and external stakeholders.
• Possess proven problem-solving skills and resourcefulness

Authorities:

• Financial: In line with Delegations of Authority Policy of the Board

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• 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
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment able to adjust to changing priorities and willing to take on new 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
• Continuous learning: Show a commitment to ongoing learning and professional development continually seeking out opportunities to expand your knowledge and skills

Required Experience:

Director