Manufacturing Deployment Lead

OpenKrill; United States; Remote; USD 120,000 - 190,000; Full time

Benefits offered by this job

Hybrid work options

Job summary

Telix Pharmaceuticals seeks a Manufacturing Deployment Lead to oversee transfers of manufacturing processes, equipment, and analytical methods to new TMS facilities. You will coordinate with Operations, QA, Regulatory Affairs, Supply Chain and external vendors to ensure regulatory compliance and smooth handoffs to TMS Operations.

Ideal candidates have a BS/BA in science, 5+ years in pharma/biotech operations (radiopharmaceuticals preferred), and strong analytical and problem-solving skills.

Qualifications

• BS/BA in science or related field; preferred
• Minimum 5 years of operational/pharma/biotech experience; radiopharmaceuticals preferred
• Strong knowledge of regulatory requirements and cGMP, FDA/NRC considerations
• Excellent interpersonal and cross-functional collaboration skills
• Willingness to travel to TMS manufacturing sites (US) as needed

Responsibilities

• Execute technology transfers for TELIX products at designated manufacturing sites
• Support facility readiness through regulatory approval and handoff to ops
• Provide on-site support for facility commissioning, equipment installation, and validation activities
• Ensure QC lab readiness, analytical method qualification and validation
• Partner with stakeholders to align expansion plans with company goals

Skills

Regulatory knowledge

Cross-functional

Problem-solving

Communication

Education

BS/BA in science

Job description

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

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.

Key Accountabilities:

• 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
• Mandatory travel to TMS manufacturing sites is required to support facility startup, qualification campaigns, validation activities, and regulatory approval processes.

Facility, Equipment, and Laboratory Readiness

• 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

Quality Systems and Documentation

• 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

Cross-Functional Collaboration

• 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.

Education and Experience:

• 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
• Location: US Frequent travel to TMS manufacturing facilities is mandatory and an essential requirement of this role.

Ways of Working:

• 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

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.

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