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 lead the analytical chemistry laboratory and team members in the development and validation of analytical methods to support the development of radiopharmaceutical manufacturing processes for clinical development. This position will be within the Translational Radiochemistry team which is part of the Early Phase CMC group. They will be knowledgeable in applicable regulatory guidance and in methodologies of the development of analytical methods for the testing of radiopharmaceuticals.
Responsibilities:
Develop analytical methods for the testing of Lilly drug products, including chromatography methods (i.e. HPLC, TLC and GC) and spectroscopy methods (i.e. gamma spectroscopy, mass spectroscopy) according to phase appropriate guidelines (e.g. cGLP, cGMP).
Manage and lead the analytical chemistry laboratory and team members to effectively execute day-to-day development and validation activities.
Prepare standard test methods and method validation protocols in accordance with appliable compendial guidelines (e.g. USP, EP and ICH).
Execute approved method validation protocols.
Provide technical expertise as required for the development, troubleshooting and tech. transfer of analytical 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.
Ensure analytical methods are designed and validated per phase appropriate requirements while meeting project timelines.
Mentor, manage, and train a team of analytical chemists.
Adhere to all applicable procedures, cGLP, cGMPs, company policies and other quality or regulatory requirements.
Maintain good relationships with partners, CDMOs, 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.
Prepare and deliver presentations for internal and external team meetings.
Author development reports, manuscripts for publication in journals, and patents.
Perform other duties as assigned.
Basic Requirements:
BS/BA, MSc, or PhD degree in chemistry or a related discipline.
9+ years for BS/BA, 7+ years for MSc, or 3+ years for PhD of relevant industry experience in analytical development, validation, and testing in a GMP setting.
Proficient in modern analytical chemistry including developing, validating, and executing methods using TLC, HPLC/UPLC, GC, NMR and mass spectrometry.
Experience in quality control testing of radiopharmaceuticals is considered an asset.
Hands-on experience with radiopharmaceutical testing including GC, Radiometric TLC and HPLC-UV with radiometric detection of PET radioisotopes (F-18, Ga-68, Cu-64) and/or theranostic radioisotopes (Lu-177, Ac-225, Tb-161) is considered an asset.
Knowledge of environmental health and radioprotection requirements are considered assets.
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.
Position will require 0 to 20% of 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 a lab 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.
Position will require 0 to 20% of travel within North America and abroad into the EU. A valid passport and eligibility to travel into these countries are required.
Work Environment:
This position’s work environment is in a Laboratory.
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 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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