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.
Experience working with unsealed radioactive materials and familiarity with exposure and contamination control practices, as well as performing radiological surveys and using radiation detection instrumentation.
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
Additional Preferences:
- Strong collaboration and communication skills, with teamwork focus and Safety as a Partner mentality.
- Excellent organization and time management skills, as well as strong analytical skills and systematic and structured way of working
- Ability to lead or contribute to cross-functional and technical teams
- Familiarity with NRC/Agreement State regulatory requirements
- Experience in a GMP or cGMP environment
Other information:
- Tasks will require entering manufacturing and laboratory areas, which require wearing appropriate PPE.
- Tasks may require actions such as entering & working in tight/confined spaces, climbing stairs, climbing ladders, and lifting / carrying heavy objects.
- Must carry a cell phone as position will support 24/7 manufacturing operations.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$28.84 - $42.31
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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