This senior position reports up through the technical services organization and is vital to the success of Lilly's monoclonal antibody and small molecule manufacturing. It is an integral part of the global parenteral network. The mission of Technical Services/Manufacturing Science (TS/MS) is to provide scientific leadership and technical support for manufacturing to make medicine today and tomorrow. The Monoclonal Antibody and Small Molecule group in the Parenteral Network provides product stewardship for all monoclonal antibody and small molecule products across multiple sites, focuses on issues of interest relative to control strategy and product quality, interfaces with product development to commercialize new parenteral products, develops new line-extensions for existing products, and implements continuous improvement projects across the parenteral network. You will be a key member in a cross-functional team by providing technical leadership for projects involving existing and new manufacturing processes and products. Support process design and scale-up, process technology transfer, validation and launch of new products and line-extensions, implementation of significant process improvements, identification and resolution of aseptic process issues, post-launch optimization of current products, and the development and implementation of specific process/technology improvements in parenteral manufacturing. Candidates should have expertise in product formulation and parenteral aseptic processing, be knowledgeable in cGMP, experimental design, statistical analysis, and in the effect of unit operations on product attributes, and the development and implementation of control strategies for parenteral products. Technical leadership and the ability to constructively influence are important in this role. Provide technical stewardship of monoclonal antibody and small molecule products. Collaborate with cross-functional team to support global parenteral manufacturing sites for new product commercialization, process improvements and technology transfers at sites including Indianapolis Parenteral Operations, Fegersheim and external manufacturing organizations. Collaborate with process engineers and development scientists to design and transfer robust manufacturing processes to commercial and third party manufacturing operations. This includes serving as a liaison to CM&C teams to shepherd new pipeline products from development into manufacturing. Design and execute necessary laboratory and pilot studies, as well as prepare technical reports and/or regulatory submissions to support business objectives. Suggest and evaluate opportunities for molecule, product and business process improvement. This includes driving the molecule/product technical agenda with a specific focus on process/productivity improvements in partnership with the Parenteral Product Network global manufacturing sites. Coach and mentor junior associates
Bachelor, Masters or Ph.D. degree in relevant area such as Pharmaceutical Science, Chemical Engineering, Biochemistry, Chemistry, or Biology.
A minimum of 3 years of industrial experience in commercial manufacturing or technical service of parenteral products and/or senior level research and technical transfer experience.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
This position does support future promotion on the Research Titles Technical Ladder and is open to qualified individuals at the salary class R1-R2.
10-20% domestic and international travel required.
Lilly is an EEO/Affirmative Action Employer and 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.