Reference Standard Scientist - Bioproduct Research and Development

Organization Overview

The Bioproduct Research and Development (BR&D) organization delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep technical expertise that works collaboratively with discovery and manufacturing colleagues. Located in Indianapolis, IN, scientists have full access to Lilly's deep pharmaceutical development expertise and engineering capabilities.

In this role, you will be part of a diverse team of analytical chemists, pharmaceutical scientists, and engineers delivering product and process understanding across a broad range of platforms. Ideal candidates will possess experience across multiple analytical techniques, demonstrate an aptitude in technical problem-solving, and be motivated to work both independently and collaboratively in a dynamic environment.

Job Description

The Corporate Reference Standards Organization (CRSO) is responsible for all corporate reference standards used at Lilly. CRSO establishes corporate technical strategy and performs or coordinates the steps required to supply laboratories with approved reference standard materials and supporting data. Activities include specification and acquisition of source material, source batch candidate disposition, formulation and package development/execution, inventory management, order fulfilment, design of analytical testing protocols, evaluation of characterization data, creation and documentation of technical rationale for all decisions, and certification of profiles for reference standards.

The Reference Standard Scientist is responsible for ensuring the technical integrity and overall compliance of Lilly reference standards and critical related materials. This includes establishing and maintaining reference standard batch replacement, manufacturing/packaging activities, inventory management, and evaluation testing. The scientist will work closely within the CRSO team and with global customers to ensure efficient and timely support of reference standard material and information deliverables.

Key Responsibilities

Technical

• Use knowledge of reference standard science, analytical testing techniques, and general analytical chemistry background to solve technical problems and issues
• Establish and execute reference standard technical strategy including source material selection, packaging, specifications, statistical design, and certification of property values
• Discern the impact of new batches prepared by a new route that differs from the previously established reference standard batch
• Work as a critical team member to handle, organize, and utilize complex data sets from multiple sources to enable data driven conclusions

Project Management

• Manage the timely delivery of work associated with reference standard manufacturing, characterization, and inventory management
• Monitor existing batches and determine appropriate plans for resupply activities based on manufacturing or source batch acquisition complexity
• Participate in processes to meet global regulatory commitments associated with reference standards
• Leverage external vendors for appropriate technical deliverables
• Manage assigned internal project load, acting in a self-directed manner in anticipation of future assignments

Reference Standard Administration

• Prepare requests for source material and packaging operations to achieve timely supply of suitable material for new reference standard batches
• Disposition source materials to document suitability for use
• Maintain relationships with high-quality collaborators and vendors to meet capacity and capability required by CRSO
• Author high quality reference standard documentation including profiles and protocols in conjunction with molecule technical experts and product stewards
• Ensure that activities are compliant with all applicable regulatory and safety requirements
• Manage the process for replacement of materials that are nearing exhaustion
• Participate in all aspects of CRSO inventory management including global customer order fulfilment

Decision Making

• Provide updates to supervision regarding progress and issues
• Responsible for decisions that ensure the reliable supply of reference standard materials
• Understand and follow all relevant policies relating to this job including business, compliance, regulatory, quality, environmental, and safety expectations

Influence

• Ability to persuade and gain consensus via indirect authority
• Influence CRSO partners to fully participate in the reference standard establishment and maintenance process
• Lead laboratory and molecule technical experts to resolve laboratory, manufacturing, and reference standard issues
• Ensure global customers can efficiently procure CRSO materials

Customer Focus/External Focus

• Interface with various customer groups to enable positive and continuously improving interactions
• Establish a relationship of trust with customers and partners
• Interact with customers with integrity and respect
• Seek feedback from customers regarding the quality and timeliness of services