Senior Scientist, Radiochemistry

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The Sr Scientist, Radiochemist position will support the development of clinical-stage radiopharmaceutical assets. This role is responsible for managing the development required to ensure manufacturing and QC procedures meet the corporate requirements to support clinical trials, regulatory submissions, and transition to commercial-stage manufacturing.

Key Accountabilities:

• Interface with key stakeholders, including external CMOs, to manage the development of manufacturing and QC procedures for clinical-stage radiopharmaceutical assets in compliance with all applicable GMP regulations. •
• Demonstrate the ability to manage multiple CMOs with little oversight from management. 
• Manage the development and validation of manual or automated manufacturing procedures as required. 
• Manage the development and validation of non-compendial QC procedures as required. 
• Generate development, validation, method transfer, and various other types of protocols and reports. 
• Author CMC sections for INDs, NDAs, BLAs, and foreign equivalents. 
• Generate SOPs for manufacturing and QC procedures. 
• Support method transfers to external manufacturers. 
• Participate in the streamlining, optimization, and scale-up of manufacturing procedures in preparation for commercial supply. 
• Provide technical support for manufacturing and QC procedures for all Telix products as required.
• Ensure all documentation generated is consistent with Telix QMS and general principles of GMP manufacturing. 

Education and Experience:

• Bachelor’s degree plus 8 years experience, or Masters degree plus 6 years experience, or doctorate plus 5 years experience. 
• Practical radiochemistry experience is required. 
• Experience developing HPLC, TLC, or GC QC methods for radiopharmaceuticals is required. 
• Experience working in GMP-compliant manufacturing is required. 
• Strong written and verbal communication skills. 
• Experience with conjugation and radiolabeling of biologics is preferred.
• Experience of method development to support regulatory filings is preferred. 

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• 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
• 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
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills