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 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.
Organizational 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 can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender.
The Clinical Trials Manufacturing organization leads the technical transfer of cGMP activities for drug product supporting clinical trials (Phase 1 through 4). CT Manufacturing is performed either externally at approved Third Party Contract Manufacturers, both in the US and OUS, or internally at Lilly commercial manufacturing facilities.
Key Responsibilities:
* The CT Manufacturing Technical Representative (Tech Rep) must demonstrate the technical ability to plan and perform cGMP activities for drug product manufacturing, including batch record preparation, oversight of manufacturing execution, sample submission, and batch record review and disposition with Quality.
* The Technical Representative partners with Development Scientists, Third Parties, and other Lilly groups to enable the manufacturing and delivery of drug product and technical information deliverables.
Key Objectives:
* Responsible for all activities associated with cGMP Drug Product Manufacturing, including technical transfer and batch record review.
* Partner with Quality Assurance to ensure drug product manufactured for clinical trials complies with Quality Assurance requirements.
* Interact with regulatory scientists to ensure clinical trial drug product matches the appropriate global regulatory documents.
* Partner with internal teams to evaluate the proper technical requirements for new drug product requests.
Educational Requirements:
* Minimum of a B.S. in Chemistry, Engineering, Pharmacy, Pharmaceutical Sciences, or similar scientific field.
* Preference of 5+ years in GMP Drug Product Manufacturing, External Manufacturing, Formulation Development or other related function.
Additional Preferences:
* Knowledge of oral (small molecule), parenteral (small and/or large molecule) formulation.
* Experience in advanced therapeutic modalities including genetic medicines & nucleic acid-based drug delivery.
* Excellent oral and written communication skills.
* Ability to clearly identify key issues in manufacturing and lead a team to appropriate solutions.
* Comfortable working in a dynamic environment with changing priorities.
* Proven experience in partnering and problem solving across both an internal and external networks.
* Knowledge of cGMP’s.
Additional Information/Requirements:
* Some domestic and/or international travel required (< 10%).
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.
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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