Director, Manufacturing Operations

Telix Pharmaceuticals Limited; Deutschland; Hybrid; EUR 150.000 - 210.000; Vollzeit

Benefits dieser Stelle

Competitive compensation

Bonus program

Equity-based incentives

Generous vacation

Paid wellness days

Learning and development support

Zusammenfassung

Telix Pharmaceuticals is seeking a senior manufacturing/CMC leader to oversee SMEs in Small Molecule API, Aseptic Fill/Finish, and Secondary Packaging, ensuring execution at the required quality level for each stage.

The role partners with CDMOs and internal Directors of CMC Programs to drive manufacturing strategies, cost-saving initiatives, and supply continuity across global operations, including international travel and complex regulatory requirements.

Qualifikationen

• BA or BS degree in Engineering, Biology, Chemistry, or another relevant field.
• 10+ years in late-stage clinical to commercial cGMP Manufacturing, Engineering, Contract Manufacturing, and/or Quality.
• 3+ years of management experience.
• Direct experience in Sterile Injectable Filling and Lyophilization for clinical and commercial products.
• Experience with Secondary Packaging of Parenteral drugs.
• Experience working with International Contract Manufacturing Organizations.
• Ability to travel ~30% domestically and internationally.

Aufgaben

• Partner with contract manufacturers to ensure quality, deliveries and costs meet Telix expectations.
• Oversee manufacturing, quality, and development from mid-stage clinical through commercial launch.
• Collaborate with Directors of CMC Programs on CDMO strategies and cost savings.
• Lead cross-functional efforts to sustain and improve CDMO networks and processes.
• Develop manufacturing and capacity strategies aligned with marketing plans (short and long term).
• Resolve complex technical issues to enable efficient business outcomes.
• Lead quality investigations and support non-conformances with product expertise.
• Mentor and manage manufacturing engineers to exceed company goals.

Kenntnisse

Leadership

cGMP Manufacturing

Sterile Fill/Finish

Lyophilization

CDMO Management

Process Validation

Cost Optimization

Travel

Ausbildung

BA/BS in Engineering, Biology, Chemistry or related

Tools

Sterile Filling Equipment

Lyophilization Equipment

Process Validation Tools

Jobbeschreibung

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 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.

Education and Experience

• 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

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.

Benefits

• competitive salaries
• annual performance-based bonuses
• an equity-based incentive program
• generous vacation
• paid wellness days
• 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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