Sr. Operator, Production Technician

Eli Lilly and Company•Us, IN

4d•$17 - $34•Onsite

About The Position

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. About POINT Biopharma: 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. Position Summary: Reporting to the Manager of Manufacturing, the Production Technician will have responsibility for: 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).

Requirements

2 to 5 years of relevant experience in a manufacturing environment or similar field of work.
Aseptic and/or cGMP manufacturing experience is preferred.
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)

Nice To Haves

Experience working with radiopharmaceuticals will be considered an asset but is not a requirement.

Responsibilities

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 manual, semi-automated, or automated visual inspection of finished pharmaceutical products (vials) to detect particulates, cosmetic defects, or container/closure integrity issues.
Apply defect classification criteria accurately and consistently in alignment with SOPs and regulatory standards.
Maintain aseptic technique and adhere to gowning procedures in classified cleanroom environments.
Perform other duties as assigned.

Benefits

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).

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume