Advisor - Translational Radiochemistry at Eli Lilly and Company

Ontario, Canada

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

PhD or MSc degree in radiochemistry, chemistry, chemical engineering, or a related discipline (PhD in radiochemistry or chemistry preferred)
Minimum 8 years for PhD or 10 years for MSc of relevant industry experience in radiochemistry, radiopharmaceutical manufacturing, organic chemistry, or process chemistry
Experience working in a pharmaceutical GMP manufacturing environment
Strong process radiochemistry

Responsibilities

Support Lilly’s early-phase radiopharmaceutical programs by leading tech. transfer and post-validation development activities of GMP production processes and test methods used in the production of Lilly’s radioligands at internal and external sites
Ensure activities are completed within the required budget and timelines
Author and oversee the preparation of CMC regulatory documents required for health authority filings including initial filings (i.e. IND, CTA, CTIS), amendments and notifications
Work cross-functionally with Regulatory, Quality Assurance, CMC, CDMOs and other vendors to ensure completion of the documents within the required timelines
Help to develop and execute overall program strategy for the delivery of radiopharmaceutical drug product programs from candidate identification to early-phase clinical studies
Provide technical support for any post-PV development or qualification activities in relation to GMP manufacturing process and analytical test methods
Support routine production operations including on-site manufacturing support, technical data review, troubleshooting, investigations, and implementation of CAPAs
Prepare and coordinate the execution of protocols (i.e. tech. transfer, process validation, method validation) associated with radioligands in accordance with applicable regulatory guidelines and the established Quality Management System
Monitor and evaluate project budget, tasks and risks; propose mitigation plans when required to ensure deadlines are met
Prepare RFPs and lead the evaluation of proposals to select new vendors and to initiate the addition of new projects with current vendors
Act as an engagement owner to select and onboard new radiopharmaceutical CDMO vendors to Lilly systems
Play a critical role in developing and maintaining good relationships with partners, CDMOs, vendors and suppliers
Adhere to all applicable procedures, cGLP, cGMPs, company policies and other quality or regulatory requirements
Provide verbal and written reports and presentations in a clear and concise manner
Perform other duties as assigned

Skills

Key technologies and capabilities for this role

GMPRadiochemistryTech TransferCMCAnalytical MethodsRegulatory FilingsINDCTACTISScale-upRadiopharmaceutical Manufacturing

Questions & Answers

Common questions about this position

What is the salary for the Advisor - Translational Radiochemistry position?

This information is not specified in the job description.

Is this a remote position, or what is the location requirement?

This information is not specified in the job description.

What are the key responsibilities or skills needed for this role?

The role requires managing development, scale-up, and tech transfer of GMP processes and analytical methods for radiopharmaceutical manufacturing, authoring CMC regulatory documents, and providing technical support for early-phase programs.

What is the team structure for this position?

The position is within the Translational Radiochemistry team, which is part of the Early Phase CMC group, and reports to the Director, Translational Radiochemistry.

What does Eli Lilly's company culture emphasize?

Eli Lilly unites caring with discovery to make life better for people, puts people first, and seeks determined individuals who give their best effort while supporting communities through philanthropy and volunteerism.

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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