Manufacturing Deployment Lead

Telix Pharmaceuticals (AMER)

20h•Hybrid

About The Position

The Manufacturing Deployment Lead oversees the deployment of new manufacturing facilities and the transfer of TELIX diagnostic and therapeutic product technologies. This role coordinates the transfer of manufacturing processes, equipment, analytical methods, documentation, and technical knowledge from development teams or established manufacturing sites to new TMS facilities, ensuring a smooth handoff to TMS Operations. Supporting both greenfield developments and expansions at existing TMS sites, this position partners with Operations, Quality Assurance, Quality Control, Engineering, Regulatory Affairs, Supply Chain, EHS, and external vendors to ensure facilities and processes meet applicable regulatory requirements. This position reports to the Senior Director, Manufacturing Deployment and Tech Transfer.

Requirements

BS/BA in a science field or related degree preferred
Minimum of 5 years of operational experience, preferably in the pharmaceutical or biotechnology industry (radiopharmaceuticals preferred)
Strong knowledge of regulatory requirements and industry standards related to pharmaceutical manufacturing facilities, including FDA regulations, BOP regulation, cGMP guidelines, NRC regulations and environmental health and safety standards
Excellent interpersonal skills, with the ability to work in a team environment and collaborate with cross functional teams
Strong analytical and problem-solving skills, with the ability to identify issues, develop solutions, and drive continuous improvement initiatives
Strong interpersonal, organizational, and managerial skills
Excellent verbal and written skills communication skills are required
Excellent attention to detail in the execution of job responsibilities
Positive attitude with excellent interpersonal skills with a proven ability to create and maintain strong working relationships with internal and external stakeholders
Possess proven problem-solving skills and resourcefulness
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

Responsibilities

Execute technology transfers for TELIX diagnostic and therapeutic products at designated manufacturing
Support manufacturing deployment from facility readiness through regulatory approval and handoff to TMS
Conduct activities in accordance with applicable cGMP requirements, including 21 CFR Parts 210, 211, and
Provide on-site technical support for facility commissioning, equipment installation, manufacturing and QC laboratory readiness, personnel implementation, and qualification and validation activities.
Support QC laboratory startup, analytical method qualification and validation, and operational
Transition technology transfer documentation from CMC into the TMS quality management
Develop and review cGMP procedures, specifications, protocols, and reports required for product technology
Support validation and implementation of the electronic quality management system across the TMS
Partner with Manufacturing, Quality Assurance, Regulatory Affairs, Supply Chain, and other stakeholders to align facility expansion and technology transfer plans with organizational objectives.
Perform other duties as assigned.