Scientist, Translational Radiochemist

Eli Lilly and Company; Ontario; On-site; CAD 80,000 - 100,000; Full time

Job summary

A leading biopharmaceutical firm in Canada is seeking a Scientist, Radiochemist to develop and validate manufacturing processes for radiopharmaceuticals. The role involves close collaboration with team members and external partners, ensuring compliance with regulatory guidelines while delivering innovative solutions in a fast-paced environment.

Qualifications

• 3+ years in radiopharmaceutical development and validation in a GMP setting.
• Skilled in automated production methods.
• Ability to prioritize projects and manage timelines.

Responsibilities

• Develop and validate radiopharmaceutical manufacturing processes.
• Produce and supply radiolabeled compounds.
• Automate manufacturing processes with synthesis units.

Skills

Radiopharmaceutical development

Process validation

GMP knowledge

Automation skills

Organizational skills

Communication skills

Education

BS / BA or MSc in chemistry

Job description

Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

About POINT Biopharma

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 Advisor, Translational Radiochemist in CMC, the Scientist, Radiochemist, Translational Radiochemist 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, and 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 are 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, and 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.

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

Equal Employment Opportunity

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 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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