Global Manufacturing Engineer
About this role
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
Global Manufacturing Engineer provides technical expertise for process development and manufacturing activities related to bulk formulation, fill/finish, lyophilization, and packaging of small molecules and biologics, ensuring processes are sufficiently developed to meet program objectives, safety standards, regulatory expectations, and quality compliance. This role is responsible for serving as the technical lead on internal cross-functional teams and with external CDMO partners, collaborating with all stakeholders to develop and execute clinical and commercial manufacturing.
Key Accountabilities:
- Technical lead of pharmaceutical development and manufacturing activities related to bulk formulation, fill/finish, lyophilization, and packaging of small molecules and biologics.
- Analyze production processes and report results. Identify and communicate gaps, risks, and inefficiencies. Drive implementation of process improvements and risk mitigations. Lead manufacturing investigations and root cause analysis.
- Manage technical collaborations with multiple contract development/manufacturing organizations (CDMOs) to provide technical support and achieve key project milestones.
- Author and review external manufacturing operation documents such as SOPs, batch records, protocols, and reports to produce clinical and/or commercial products.
- Author and support the submission of CMC sections in IND, NDA, BLA, and related regulatory filings
- Ensure appropriate compliance through document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system.
Education and Experience:
- Science or engineering degree with 4+ years of relevant operational pharmaceutical experience across a breadth of functions including but not limited to, manufacturing operations, bioprocessing technology, validation, and engineering
- Experience in MS Office suite applications (e.g., Excel, Word, Project)
- Experience working with cross-functional teams, external partners and CDMOs
- Experience in authoring challenging technical documents, including but not limited to, protocols, reports, CMC modules, and filing response.
- Strong experience in a key functional area within pharmaceutical operations
- Experience in pharmaceutical and process development
Key Capabilities:
- Autonomy: Comfortable working independently with senior-level support
- Strong communication skills: Able to communicate effectively with internal and external colleagues and stakeholders, using clear and concise language.
- Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
- Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
- 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
- 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
- Travel expectation: 10 – 25% for key in-person meetings, partner site visits, and SME/technical person-in-plant assignments.
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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