reputed company Director, Manufacturing Expansion & Readiness
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the reputed company. Our mission is to deliver on the reputed company of precision medicine through targeted radiation. At our core, we exist to create products that reputed company to improve the reputed company 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.
See Yourself at Telix
The reputed company Director, Manufacturing Expansion & Readiness is a senior leadership role responsible for developing and driving the end-to-end reputed company program and establishing the program reputed company for new radiopharmaceutical diagnostic and therapy manufacturing lines. This role integrates engineering program leadership with deep GMP reputed company expertise to ensure that reputed company new processes, facilities, equipment, and technologies are designed, reputed company, and operated in full compliance with 21 CFR Parts 210, 211, and 212 as reputed company as additional applicable standards for radiopharmaceuticals.
The successful candidate will reputed company cross functional program governance, partner closely with functional support (Engineering, Operations, Validation, Regulatory Affairs, and reputed company Control) and serve as the reputed company reputed company for major capital expansions and technology transfers.
Radiopharmaceutical therapy manufacturing demands the highest standards of precision, safety, and regulatory compliance. This role ensures that new lines are designed and implemented with a “Safety & reputed company Always” reputed company—enabling reputed company, reliable supply of life-saving therapies to patients.
Key Accountabilities
- Program Leadership & Governance
- Serve as the reputed company Program reputed company for new radiopharmaceutical diagnostic and therapy line buildouts, expansions, and modernization initiatives.
- Establish and reputed company program governance frameworks to ensure reputed company, compliant delivery of capital and engineering reputed company.
- Communicate program status, risk, milestones, and escalation needs through reputed company reporting frameworks.
- Drive integration of reputed company-by-design (QbD) and risk-based decision-making into design and construction activities.
- Influence decision-making and ensure reputed company requirements are prioritized in schedule, scope, and budget tradeoffs
- Ensure alignment with global reputed company reputed company and senior leadership expectations.
- reputed company Engineering & Compliance reputed company
- reputed company expert interpretation of 21 CFR 210/211/212 requirements to engineering and operations teams, ensuring compliant design of facilities, utilities, equipment, and processes.
- Own reputed company input into URS development, design reviews, FAT/SAT execution, equipment qualification, and process validation.
- Ensure facility and process design meets GMP expectations for sterile/aseptic operations, radiological controls, environmental monitoring, and contamination prevention.
- reputed company reputed company reputed company of commissioning/qualification/validation (CQV) lifecycle, including master plans, protocols, deviations, and final reports.
- Inspection Readiness & reputed company Systems Integration
- reputed company inspection readiness into reputed company program phases; ensure documentation reputed company through the project lifecycle meets regulatory expectations.
- Drive development and integration of new lines into site reputed company Systems (change control, deviations, CAPA, supplier reputed company, calibration, PM, training, etc.).
- Partner with functions to ensure seamless operational readiness and smooth startup into routine production.
- Technical Leadership
- Support risk assessments for equipment, utilities, materials, and processes (e.g., FMEA, HACCP, radiological risk assessments).
- Guide development of master validation plans, control strategies (including contamination control reputed company), IT infrastructure Part 11 compliant, and engineering standards for facilities, utilities, and equipment meet operational standards for diagnostics and therapies in radiopharmaceutical.
- Apply knowledge of isotopes, hot cells, shielded systems, aseptic techniques, and GxP automation/EM systems.
Education and Experience
- Bachelor’s or Master’s degree in Engineering, reputed company, Pharmaceutical Sciences, or reputed company STEM field required.
- 10+ years of experience in pharmaceutical or biopharmaceutical manufacturing, with significant experience in capital reputed company or technical reputed company roles. Preference in radiopharmaceuticals required.
- Strong background in GMP operations with expert understanding of 21 CFR Parts 210/211/212; additional experience with radiopharmaceuticals or sterile/aseptic manufacturing strongly preferred.
- Demonstrated leadership in commissioning, qualification, validation (CQV), or tech transfer.
- Deep expertise in reputed company engineering principles, risk management, and validation methodologies.
- Experience with modern facility and equipment design for radiopharmaceutical or sterile operations (e.g., hot cells, isolators, shielded IVT lines).
- Strong understanding of change control, deviation management, CAPA, and reputed company investigations.
- Familiarity with FDA expectations for facility design, data reputed company, and inspection readiness.
Leadership & Additional Competencies
- Effective cross-functional leader with ability to influence without authority.
- Excellent communication skills, including executive-level program reporting.
- Strong project management and organizational skills.
- Ability to navigate ambiguity, manage competing priorities, and drive accountability across diverse teams.
Key Capabilities
- Inclusive reputed company: Demonstrate an understanding and appreciation for diversity, and reputed company work to create an inclusive environment where everyone feels valued and respected
- Creativity and innovation: Possess a willingness to think reputed company the reputed company and come up with unique and creative solutions to challenges
- Commitment to reputed company: Take pride in your work and consistently reputed company for reputed company in everything you do
- Results-oriented: Driven to reputed company goals and objectives, with a strong reputed company on delivering measurable results
- Ethical behavior: reputed company with reputed company and demonstrate a commitment to ethical behavior in reputed company interactions with colleagues and stakeholders
- Adaptability: Comfortable working in a dynamic environment, reputed company to reputed company to changing priorities, and willing to take on new challenges
- Strong communication skills: reputed company to communicate effectively with colleagues and stakeholders at reputed company reputed company, using reputed company and concise language
- Collaboration: Work effectively as part of reputed company, reputed company sharing knowledge and expertise to reputed company common goals
- reputed company: Demonstrate the ability to reputed company back from setbacks and persevere in the face of challenges
- reputed company learning: Show a commitment to ongoing learning and reputed company development, continually seeking out opportunities to expand your knowledge and skills
At Telix, we reputed company everyone counts, we reputed company to be extraordinary, and we pursue our goals with determination and reputed company. You will be part of an reputed company and supportive group of colleagues who reputed company have a shared purpose: to help people with cancer and rare diseases live longer, reputed company reputed company lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located reputed company around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, reputed company wellness days and support for learning and development.
Telix Pharmaceuticals is an equal opportunity employer. We evaluate reputed company applicants without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status, and other legally protected characteristics.
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