Production Technician Ii

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 Manufacturing Team Lead, 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).

Roles and Responsibilities of the Position:

• 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.
• Preparation of packages for distribution as per the regulations for the Transportation of Dangerous Goods (TDG), Packaging and Transport of Nuclear Substances (PTNS), as well as International Air Transport Association (IATA)
• 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.

Required Qualifications:

• 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.

Additional Preferences:

• Aseptic and/or cGMP manufacturing experience is preferred.
• Experience working with radiopharmaceuticals will be considered an asset but is not a requirement.

Physical Demands/Travel:

• 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.
• Ability to maintain focus on a complex task for 4-6 hours at a time.

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:

• Position is onsite during the weekday.
• Comfortable handling radioactivity and follow proper ALARA (As Low As Reasonably Achievable) technique.
• Aseptic gowning.
• This role works in a hospital setting and it is mandatory for all employees to complete health screens before onboarding. In the event the screen results show non-immunity, vaccines may need to be administered.

Theworkenvironmentcharacteristicsdescribedherearerepresentative 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.

Eli Lilly Canada is committed to employment equity. We encourage applications from qualified women, members of visible minorities, aboriginal peoples, and persons with disabilities.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly 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.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly 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.

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