Lead Specialist - Radiation Safety

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Lilly's Indianapolis Radioligand Therapy (Indy RLT) facility aims to transform precision oncology by combining a portfolio of targeted radioligand assets, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes - building a platform for the clinical development and commercialization of radioligands that fight cancer.

Main Purpose and Objectives of Position: 

The Lead Specialist, Radiation Safety (RS) is part of the Indy RLT Health, Safety, and Environmental and Radiation Safety (HSE-RS) team and provides technical expertise and operational support in the development, implementation, and maintenance of RS programs. This role focuses primarily on Radiation Safety programs but may include HSE programs, as needed.

The Lead Specialist, RS role will be fluid and dynamic as the Indy RLT team endeavors to develop and implement the necessary systems and business processes required to support GMP operations and build the site safety culture. This will require significant collaboration and resilience as the site grows through startup to full scale GMP manufacturing.

Post start-up, this role will continue to be the main resource for daily and weekly foundational radiation safety program maintenance and provide technical guidance and lead radiological incident prevention and response for manufacturing and support units.  The duties of the Lead Specialist, RS align with a 24/7 manufacturing schedule; the position entails day, night, weekend, and/or variable shift coverage.

Key Responsibilities for this role include:

• Perform fundamental radiation safety-related tasks daily, including performing quantitative surveys for radioactive contamination and area radiation fields, collecting, replacing, and analyzing particulate and liquid samples, conducting radiation instrument constancy testing and calibration tracking, and completing / reviewing radiation safety-related documentation to maintain audit and inspection readiness.
• Assist with routine HSE compliance activities by performing scheduled safety inspections and other compliance-related activities.
• Provide comprehensive Job Hazard Analyses (JHA) and provide field presence for various manufacturing and laboratory activities to ensure appropriate controls are being utilized and JHA recommendations have been appropriately implemented.

• Lead implementation of assigned RS operational readiness programs, such as equipment management, constancy testing, radiological surveys, radiological sample collection & analysis, and radioactive waste management as well as cross-functionally support HSE programs as needed.
• Provide input and feedback on radiation safety-related design decisions, leveraging existing knowledge, and incorporating external experiences and learning.
• Assist in the development and roll out of radiation safety programs, procedures, and tools, including training, mentoring, and onboarding of new staff to help support a strong HSE-RS culture at the site.
• Develop a partnership with Operations, Maintenance, and Engineering functions to help manage change, assure safety and compliance of new systems, and assist in setting requirements to ensure safe and compliant operations.
• Help operational teams understand the site-specific and regulatory requirements of their areas and programs; work with them in implementing solutions that comply with these regulations and programs.  Facilitate the implementation of the programs.
• Complete internal HSE-RS audits/assessments, lead/support HSE-RS incident prevention and response efforts & investigations as well as corrective action implementation.
• Serve as liaison between site & company subject matter experts, area owners, and contractors (as related to program needs) – finding process solutions with safety and compliance as priority.

Requirements:

• Bachelor’s degree in engineering or related science (e.g., radiological health, health physics, chemistry, biology, occupational safety/health, industrial hygiene)
  • ALTERNATE: 3+ years of experience in a pharmaceutical manufacturing environment, or similar, in a role requiring technical aptitude.
  • ALTERNATE: Formal training as a Radiological Controls Technician