Scientist, Reference Standard Manufacturing - BRD Corporate Reference Standards Organization; CRSO

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.

The Reference Standard Manufacturing Scientist is responsible for ensuring the technical integrity, reliable supply of materials, and overall compliance of Lilly reference standard manufacturing activities.

The Scientist will have influence in all phases of drug development, product registration, and marketed product support by ensuring that reference standard manufacturing strategies are properly established, executed, and maintained to deliver suitable reference standards.

The individual will ensure that materials, manufacturing process, and the certifying documentation are scientifically sound, properly integrated with analytical control strategies, and compliant with all corporate and regulatory requirements. The individual will work closely with global Lilly scientists, internal partners, and external third-party manufacturers to ensure efficient and timely support of material and information deliverables.

• Broadly understands reference standard sub-division processes, specifically vial lyophilization and solution reference standards
• Qualifies and maintains relationships with high-quality vendors to meet capacity and capability required by CRSO
• Uses understanding of control strategies to select source materials, design packaging, manage inventory, manage equipment and facilities, and design protocols.
• Leads global technical teams to ensure that the manufacturing instructions and associated documentation for in-house production, or manufacturing by vendors, is appropriate and justified for any changes for replacement batches.
• Directs the acquisition of data required to disposition a candidate source batch material
• Performs activities needed to ensure timely resupply of source batch materials and manufacture of candidate reference standard batches
• Establishes and maintains the SOPs that govern these activities
• Develops and maintains training materials associated with reference standard manufacturing
• Fulfills the role of RS Information Scientist, as needed, by autonomously designing, collaborating on, authoring or reviewing scientific conclusions and content of documents such as reference standard protocols and profiles
• Applies statistical techniques, defines appropriate calculations, and makes conclusions to support key suitability decisions
• Ensures that activities are compliant with all applicable regulatory and safety requirements
• Continually improves the reference standard manufacturing process

• Accountable for the successful management and timely delivery of all work in progress associated with reference standard manufacturing
• Monitors existing batches and determines which resupply activities must start earlier than normal based on manufacturing or source batch acquisition complexity
• Leads the team of laboratories and other key stakeholders associated with executing fill/finish activities, including the authorship of the reference standard protocol
• Establishes appropriate plans for material supply, storage, and distribution activities based on material properties and uses
• Defines and executes appropriate actions based on trends and the outcome of metrics
• Autonomously manages assigned internal project load; acts in a self-directed manner in anticipation of future assignments
• Prioritizes work based upon key milestones and uses the principles of project management to consistently meet rigid timelines
• Leverages internal and external vendors for appropriate technical deliverables and required capacity
• Creates high-quality documentation in conjunction with molecule technical experts, product…