Scientist, Translational Radiochemist Full-time

Radiochemist, Translational Radiochemistry

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.

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.

Reporting to the Translational Radiochemist Scientist in CMC, the Radiochemist, Translational Radiochemistry will develop manufacturing processes as directed and validate manufacturing processes to support the production of radiopharmaceuticals for use in clinical development. They will work in the laboratory in collaboration with team members, other departments, external partners (CMOs). They will be knowledgeable in applicable regulatory guidance and in methodologies of the development and validation of radiosynthesis, purification, and formulation processes.

Objectives:

• Develop and validate processes for the manufacture of POINT drug products, including radiosynthesis, purification, and formulation, according to phase appropriate guidelines (e.g. cGLP, cGMP)
• Produce and supply radiolabeled compounds to support the preclinical evaluation of novel radioligands.
• Support the development of cGMP radiopharmaceutical manufacturing processes to enable clinical development activities.
• Automate manufacturing production processes using automated synthesis units
• Author master batch records and process validation documents.
• Execute approved process validation protocols
• Provide technical expertise as required for the development, troubleshooting and tech transferring of manufacturing methods to external vendors/ partners
• Review experimental data both internally and from external vendors/ partners. Summarize and interpret results, relaying findings through summary reports, technical documents, or presentations

Accountabilities:

• Ensure manufacturing processes arc designed and validated per phase appropriate requirements while meeting project timelines
• Adhere to all applicable procedures, cGLP, cGMPs, company policies and other quality or regulatory requirements
• Maintain good relationships with partners, CMOs, vendors and suppliers.
• Embody and promote a quality culture and “right-the-first-time” approach to all activities
• Work well in a fast-paced environment
• Perform other duties as assigned
• Prepare and deliver presentations for internal and external team meetings.
• Author development SOPs, reports, manuscripts for publication in journals, and patents

Required Qualifications:

• BS/BA or MSc degree in chemistry or a related discipline
• 3+ years of relevant industry experience in radiopharmaceutical development and validation in a GMP setting
• Skilled in the development and optimization of automated radiopharmaceutical production methods
• Proven ability to work independently with strong organization and communication skills
• Demonstrated ability to successfully prioritize projects and manage timelines in a fast-paced Environment
• Functional knowledge of GMPs and applicable FDA, EMA, Health Canada, USP, ICH and PDA Guidelines

Additional Preferences:

• Experienced in radiochemistry development. Hands-on experience with imaging radioisotopes (F-18, Ga-68, Cu-64, Zr-89, In-111) and/or therapeutic radioisotopes (Lu-177, Ac-225, Tb-161, Cu-67, Pb-212) is considered an asset.
• Knowledge of environmental health and radioprotection requirements are considered assets
• Experienced in quality control testing of radiopharmaceuticals is considered an asset

Physical Demands / Travel:

• Position will require to 20% of travel within North America and abroad into the EU. A valid passport and eligible to travel into these countries are required

Work Environment:

• Position requires to be onsite during the work week.
• 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.

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

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.