Director, Manufacturing Operations

Telix Pharmaceuticals Limited; Canada; On-site; CAD 120,000 - 180,000; Full time

Benefits offered by this job

Equity-based incentive program

Annual performance-based bonuses

Generous vacation

Paid wellness days

Support for learning and development

Job summary

Telix Pharmaceuticals is seeking an experienced manufacturing/CMC leader to drive process development and operations for late-stage clinical to commercial products. You will oversee global manufacturing, quality, and CDMO partnerships, ensuring supply chain robustness and regulatory readiness.

The role requires 10+ years in cGMP manufacturing, strong leadership, and a track record with sterile fill/finish and lyophilization. Travel up to 30% is expected, with global collaboration across regions.

Qualifications

• BA or BS in Engineering, Biology, Chemistry, or a relevant field.
• 10+ years of experience in late-stage clinical to commercial cGMP manufacturing or related fields.
• 3+ years of management experience.
• Direct experience in sterile injectable filling and lyophilization of drug products.
• Direct experience in secondary packaging of parenteral drugs.
• Experience with international CDMOs.
• Ability to travel ~30% domestically and internationally.

Responsibilities

• Oversee manufacturing, quality, and development from mid-stage clinical through commercial launch.
• Collaborate with Directors of CMC Programs to sustain, monitor, and improve CDMO strategies.
• Determine strategies for cost savings, supply redundancy, and process improvement within the CDMO network.
• Develop manufacturing and capacity strategies aligned with current and future marketing plans.
• Lead technical transfers and process validation at internal and external CDMOs.
• Manage complex technical issues to ensure business resolution and support quality investigations.
• Provide leadership, development, and performance management of manufacturing engineers.
• Serve as technical lead for business reviews with suppliers/contracting organizations.

Skills

Leadership

Communication

Collaboration

Adaptability

Ethical behavior

Continuous learning

Problem solving

Education

Bachelor's degree in Engineering, Biology or Chemistry

Job description

Unsolicited job offers that attempt to phish for personal data have become increasingly prevalent online. Telix does not make any offers outside the official application process and will not make unsolicited contact.

Genuine vacancies are only posted on our website and official social media accounts.

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 s 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 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 exceedTelix's expectations.
• Provide oversightintothe manufacturing, quality, and development of products frommid-stage clinical through commercial launch.
• Partner withthe 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 improvementwithinCDMO network.
• Partner with Programleadership, Supply Chain, and the Directors of CMC Programsto develop manufacturing and capacity strategies consistent with the current and future marketing strategies (short and long term).
• Managecomplex technicalissues to ensure efficient and effective business resolution.
• Support quality investigations and non-conformances by providingappropriate productexpertise.
• Leadership, development, and performance management of the team ofmanufacturing engineers for the purpose of driving team capabilities to surpass company goals, including employing initiatives to coach employees tooptimizetheir contribution and outputs.
• Technicallead forbusiness reviews with suppliers/contracting organizations.
• Oversee technical transfers and process validation at internal and externalCDMOs.

Education and Experience:

• BA or BS degree in Engineering, Biology, Chemistry, orotherrelevant field
• 10+ years combined experience inlate-stage clinical to commercialcGMP Manufacturing, Engineering, Contract Manufacturing,and/orQuality
• 3+ years ofpreviousmanagement 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 drugsubstancemanufacturing 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

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.