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.
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.
Position Summary:
Reporting to the Director, Translational Radiochemistry, the selected candidate will manage and be a technical expert in the development, scale-up and tech transfer of GMP processes and analytical methods for radiopharmaceutical manufacturing, and the preparation and authorship of CMC-related documents required to support regulatory filings. This position will be within the Translational Radiochemistry team which is part of the Early Phase CMC group.
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.
Basic Requirements :
PhD or MSc degree in radiochemistry, chemistry, chemical engineering, or a related discipline.PhD in radiochemistry or chemistry is 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 and analytical chemistry skills. Demonstrated experience with imaging radioisotopes (F-18, Ga-68) and therapeutic radioisotopes (Lu-177, Ac-225) is required.
Knowledge of environmental health and radioprotection requirements are considered assets.
Proven ability to work independently with strong organization and communication skills.
Demonstrate 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
Position will require up to 50% travel within North America and abroad into the EU.A valid passport and eligibility to travel into these countries are required.
Additional Information
Physical Demands/Travel:
The physical demands of this job are consistent with an office environment .
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:
This position's work environment is in an office setting.
The work environment characteristics described here are representative 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.
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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$121,500 - $198,000
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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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