Sr. Operator, Production Technician

Industry:

Company: Eli Lilly and Company

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.

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 39,000 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. #WeAreLilly

POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. Recently acquired by Eli Lilly and Company, POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT is a wholly owned subsidiary of Eli Lilly and Company. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT is a wholly owned subsidiary of Eli Lilly and Company.

Responsibilities:

• Aseptic production of radiopharmaceutical drug product and radioisotopes in accordance with established manufacturing batch records.
• Support the technical transfer, development, and validation of production methods associated with finished dosage form (FDF) drug products and radioisotope products.
• Investigate, resolve, and mitigate deviations, non-conformances, and OOS (Out of Specification) events associated with product manufacturing at the POINT GMP facility.
• Monitor production-related equipment to ensure proper function and compliance with the established calibration / PM equipment schedule.
• Continuous process improvement of existing manufacturing methods via Current Good Manufacturing Practices (cGMP).
• Produce radioisotopes and drug products following cGMP guidelines and resolve all production-related quality events in a timely manner.
• Coordinate production activities with Quality Control, Quality Assurance, and Plant Maintenance to facilitate on-time release of drug product and radioisotopes.
• Participate in technical transfer and process validation activities in collaboration with other departments.
• Safely work with radioactive materials following ALARA principles and NRC guidelines.
• Utilize and monitor all manufacturing-related equipment.
• Conduct and appropriately document aseptic production of radiopharmaceutical drug product and radioisotopes via strict adherence to manufacturing batch records and affiliated SOPs.
• Safely handle and participate in the transfer of radioactive materials throughout the facility.
• Monitor manufacturing equipment to ensure performance and safety standards are met.
• Collaborate with maintenance technicians, equipment manufacturers, and quality assurance to ensure that all production equipment is in good working order and is validated for use.
• Provide verbal and written reports to supervisors in a clear and concise manner.
• Maintain accurate and complete lab data notebooks as per cGLP and/or cGMP, as appropriate.
• Adhere to all applicable procedures, cGLP, cGMPs, company policies and any other quality or regulatory requirements.
• Embody and promote a quality culture and due diligence approach as part of all activities.
• Work well in a fast-paced team environment.
• Perform other duties as assigned.

Basic Requirements:

• BS/BA degree in a science related field of study is preferred. Other degrees and certifications will be considered with a combination of relevant work experience.
• 3 to 5 years of relevant experience in a manufacturing environment or similar field of work.
• Hours of work will require shift work on the requirements as we progress into next phases. Flexibility is required.

Additional Preferences:

• Aseptic and/or cGMP manufacturing experience is preferred.
• Experience working with radiopharmaceuticals will be considered an asset but is not a requirement.
• Ability to maintain focus on a complex task for 4-6 hours at a time
• Adaptable to work in a fast-paced and evolving environment
• Maintain clear, consistent, and constant verbal communication with one or more team members during performance of duties
• Comfortable handling radioactivity and follow proper ALARA (As Low As Reasonably Achievable) technique
• Full range of motion and ability to use both hands mandated by machinery. High degree of manual dexterity. Regular lifting of 10 lb weights, occasional lifting of up to 50 lbs
• Excellent oral and written communication skills
• Very detail oriented and meticulous with execution of tasks and documentation
• Work collaboratively in a team environment
• Operate and execute with a sense of urgency
• Excellent organizational and interpersonal skills
• Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel)

Additional Information:

This position’s work environment is on site at the 4850 W 78th St, Indianapolis Facility.

Physical Demands/Travel:

The physical demands of this job are consistent with a manufacturing environment

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

This position’s work environment is a manufacturing environment.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Lilly currently anticipates that the base salary for this position could range from between $36,000 to $71,500 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. 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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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.

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly