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.

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 also 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. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

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, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond. Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself

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. These activities include batch record preparation, oversight of manufacturing execution, sample submission, and batch record review and disposition with Quality for multiple types of manufactures.The CT Manufacturing Technical Representative partners with Development Scientists, Third Parties and other Lilly groups (e.g., CT Packaging, Regulatory, Quality Assurance, Analytical, Project Management, and Commercial Manufacturing) to enable the manufacturing and delivery of drug product and technical information deliverables. Additionally, the Technical Representative works closely with the CT Manufacturing Operations group to enable planning, scheduling, material movement, budget development and testing. 

Key Objectives:

Drug Product Manufacturing Technical Lead: Responsible for all activities associated with cGMP (Good Manufacturing Practices) Drug Product Manufacturing. Partner with internal team members and manufacturing site to facilitate all required activities leading up to GMP Manufacturing. These activities include technical transfer, authoring of required technical documentation, and batch record review and approval. The Technical Representative is also responsible for manufacturing partner oversight and facilitating decision-making discussions during GMP activities. Finally, the Technical Representative is responsible for final review of batch record and collaborating with quality assurance representatives for final disposition of drug product batch.Ensure Quality Supply of Drug Product: Partner with Quality Assurance to ensure drug product manufactured for clinical trials complies with Quality Assurance requirements. Facilitate all discussions associated with deviations at external manufacturing sites and provide technical insight and recommendations for deviations. Finally, the technical representative manages significant manufacturing process modification.Regulatory Compliance: Interact with regulatory scientists to ensure clinical trial drug product matches the appropriate global regulatory documents. The Tech Rep contributes to the preparation of IND Regulatory Content required to support drug product submission. Facilitation of Drug Product Manufacturing Site Selection and Contracting: Partner with internal teams to evaluate the proper technical requirements for new drug product requests. CT Tech Reps influence appropriate site selection based upon product requirements and capacity and capabilities at partners within Lilly’s internal and external manufacturing network. Partner with procurement representatives, technical teams (formulation development, analytical methods development, engineering, device development, packaging, labeling), and commercialization manufacturing counterparts to draft contractual request for manufacturing at external sites, when applicable.

Educational Requirements:

Minimum of a B.S. in Chemistry, Engineering, Pharmacy, Pharmaceutical Sciences, or similar scientific fieldPreference 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) formulationExperience in advanced therapeutic modalities including genetic medicines & nucleic acid-based drug delivery via intravenous, subcutaneous, intrathecal and/or inhaled routes of administration.  This experience may include gene therapy, siRNA-antibody or siRNA-peptide conjugates, oligonucleotides, mRNA, viral nanoparticles, non-viral particles (lipid nanoparticles, liposomes, exosomes/extracellular vesicles), microparticles (traditional polymeric and cross-linked), viral vectors, adeno-associated virus (AAVs)Excellent oral and written communication skills with an ability to communicate clearly with peers and leadership.Ability to clearly identify key issues in manufacturing and lead a team to the appropriate solution(s).Comfortable working in a dynamic environment with changing priorities and short lead times.Initiative and ability to handle multiple independent projectsProven 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, 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.

#WeAreLilly