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Senior Scientist -Manufacturing/ Technical Services - United States  

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Posted on : 15 April 2017

Project Description

Senior Scientist -Manufacturing/ Technical Services
United States
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 39,000 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.
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 manufacturing 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 in collaboration across the parenteral network. The Research Scientist is a key member in a cross-functional team by providing technical leadership for projects involving existing and new manufacturing processes and products. This includes support for 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. The candidate 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. Specific knowledge relative to monoclonal antibody and small molecule products including drug delivery devices is an advantage. Technical writing and communication skills are used daily and the ability to effectively communicate and transfer knowledge to all levels of competency is essential. Technical leadership and the ability to constructively influence are important in this role.

  1. Provide technical stewardship of monoclonal antibody and small molecule products.
  2. 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.
  3. 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.
  4. Design and execute necessary laboratory and pilot studies, as well as prepare technical reports and/or regulatory submissions to support business objectives.
  5. 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.
  6. Coach and mentor junior associates.
  1. Bachelor, Masters or Ph.D. degree in relevant area such as Pharmaceutical Science, Chemical Engineering, Biochemistry, Chemistry, or Biology.
  2. 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.
  3. 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
  1. Demonstrated examples of leadership, influence, and problem solving skills.
  2. Demonstrated ability to analyze and interpret complex technical data and troubleshoot data issues.
  3. Strong written and oral communication skills.
  4. Preparation, review and response preparation of global regulatory submissions i.e. BLAs and NDAs and other technical communications.
  5. Ability to Leadership teams to successfully deliver projects on time and in scope.
  6. Working knowledge of statistical design of experiments and analysis.
  7. Working knowledge and scientific understanding of product distribution, drug delivery devices and advanced drug delivery systems.
  • 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.