Director, Commercial CMC Programs

Telix Pharmaceuticals Limited; Australia; Hybrid; CAD 180,000 - 260,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

Equity-based incentive program

Generous vacation

Wellness days

Learning and development support

Job summary

Telix Pharmaceuticals is seeking a Director, CMC Programs to lead a global team responsible for manufacturing, quality, and development of Telix assets from late-stage clinical through commercial manufacturing.

You will coordinate with Regional Operations, Supply Chain, Program leadership, and the Director of Manufacturing Operations to ensure timely, compliant CMC execution and scalable production strategies.

Qualifications

• Bachelor's degree in engineering, biology, chemistry, business, or related field.
• 10+ years in cGMP manufacturing, contract manufacturing, business development, or quality.
• Experience leading cross-functional teams and managing external partners/CDMOs.
• Direct experience in sterile injectable filling and lyophilization of drug products.
• Direct experience in secondary packaging of parenteral drugs.
• Experience with complex formulations of bulk drug substances and biologic drug substance manufacturing.
• Experience managing international contract manufacturing organizations.
• Travel ~30% domestically and internationally.

Responsibilities

• Oversee CMC programs and lead a team of CMC program leads.
• Set up and solidify global production, supply chain, logistics, and distribution for late-stage to commercial.
• Coordinate with Regional Operations leadership, Supply Chain, Program leadership and Manufacturing Operations.
• Lead commercial manufacturing budget management and continuous improvement.
• Drive ECM strategy and governance with internal and external partners.
• Manage ECM metrics, scorecards, and performance reviews with suppliers.

Skills

Cross-functional leadership

CDMO experience

External partner management

Strategic planning

Communication

Education

BA/BS in Engineering

BA/BS in Biology

BA/BS in Chemistry

BA/BS in Business

Job description

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.

See Yourself at Telix

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.

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, 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
• Education and Experience:
  • 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

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality 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 all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

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