Reference Standard Scientist - Bioproduct Research and Development

Eli Lilly and Company • Us, IN

3d

About The Position

The Reference Standard Scientist is part of Lilly’s Bioproduct Research and Development organization and the Corporate Reference Standards Organization (CRSO), which supplies laboratories with approved reference standard materials and supporting data. The role ensures the technical integrity and compliance of Lilly reference standards and related critical materials, including batch replacement, manufacturing and packaging activities, inventory management, and evaluation testing. The scientist collaborates with the CRSO team, molecule technical experts, product stewards, vendors, and global customers to deliver reference standard materials and information efficiently and on time.

The position applies reference standard science, analytical testing, and general analytical chemistry to establish technical strategies, assess source materials and new batches, evaluate characterization data, and document decisions. It also manages projects and inventory, supports regulatory commitments, prepares technical documentation, and helps resolve laboratory, manufacturing, and reference-standard issues. The anticipated wage is $66,000–$148,500. Full-time equivalent employees are eligible for a company bonus, and eligible employees may participate in a comprehensive benefits program.

Requirements

• B.S. in Chemistry and at least 3 years of pharmaceutical analysis or production experience, or M.S. in Chemistry and at least 1 year of pharmaceutical analysis or production experience.
• Strong knowledge of analytical sciences, including measurement techniques, specifications, and statistical analysis of data.
• Project management skills.
• Understanding of chemical synthesis, purification techniques, formulation, packaging, and inventory management.
• Ability to respond to changing priorities while maintaining accuracy and attention to detail.
• Demonstrated scientific problem-solving skills.
• Influencing and coaching skills.
• Experience with computerized inventory management.
• Strong proficiency with statistical tools such as Excel and JMP.
• Strong communication skills.
• Strong compliance background.
• Must be authorized to work in the United States on a full-time basis; the company will not sponsor work authorization or visas for this role.

Nice To Haves

• Experience with the science of reference standards.

Responsibilities

• Use reference standard science, analytical testing techniques, and analytical chemistry knowledge 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.
• Assess the impact of new batches prepared by a route that differs from the previously established reference-standard batch.
• Organize and use complex data sets from multiple sources to support data-driven conclusions.
• Manage timely delivery of reference-standard manufacturing, characterization, and inventory-management work.
• Monitor existing batches and determine resupply plans based on manufacturing or source-batch acquisition complexity.
• Participate in processes to meet global regulatory commitments associated with reference standards.
• Use external vendors for appropriate technical deliverables and manage assigned internal projects in a self-directed manner.
• Prepare requests for source material and packaging operations to ensure timely supply of suitable material for new reference-standard batches.
• Disposition source materials and document their suitability for use.
• Maintain relationships with collaborators and vendors to meet CRSO capacity and capability needs.
• Author reference-standard profiles, protocols, and other documentation with molecule technical experts and product stewards.
• Ensure activities comply with applicable regulatory and safety requirements.
• Manage replacement of materials nearing exhaustion and participate in CRSO inventory management, including global customer order fulfillment.
• Provide supervisors with progress and issue updates and make decisions that ensure reliable supply of reference-standard materials.
• Follow applicable business, compliance, regulatory, quality, environmental, and safety policies and expectations.
• Influence CRSO partners to participate in reference-standard establishment and maintenance; lead laboratory and molecule technical experts in resolving related issues.
• Help global customers efficiently procure CRSO materials.
• Interface with customer groups, build trusted relationships, seek feedback, and support positive, continually improving customer interactions.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) participation eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits eligibility.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level