[Hiring] Manufacturing Deployment Lead @AMER

Role Description

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

• Technology Transfer and Manufacturing Deployment
  • 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.
• 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 readiness.
  • Mandatory travel to TMS manufacturing sites is required to support facility startup, qualification campaigns, validation activities, and regulatory approval processes.
• Quality Systems and Documentation
  • Transition technology transfer documentation from CMC into the TMS quality management system.
  • Develop and review cGMP procedures, specifications, protocols, and reports required for product technology transfer.
  • 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.

Qualifications

• 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.

Requirements

• 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 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.
• 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.