Scientist, Reference Standard Manufacturing - BRD Corporate Reference Standards Organization (CRSO)

About the role

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. This role involves influencing all phases of drug development, product registration, and marketed product support by establishing, executing, and maintaining suitable reference standards.

Responsibilities

• Establish and maintain the SOPs that govern reference standard manufacturing activities.
• Lead global technical teams to ensure appropriate manufacturing instructions and documentation.
• Manage and coordinate resupply activities for source batch materials and manufacture of reference standard batches.
• Collaborate with CRSO partners to ensure full participation in the reference standard manufacturing process.
• Resolve technical issues and lead investigations of departures from quality standards.
• Ensure compliance with all applicable regulatory and safety requirements.
• Manage multiple complex projects concurrently, responding to changing priorities and maintaining accuracy and attention to detail.
• Communicate critical information to relevant stakeholders and interact with external sources to obtain material.

Requirements

• Master's degree in Chemistry, Biochemistry, Life Science, or related field with 3 years of relevant experience in the pharmaceutical industry.
• Bachelor's degree in Chemistry, Biochemistry, Life Science, or related field with 5 years of relevant experience in the pharmaceutical industry.
• Knowledge of measurement techniques and statistical analysis of data.
• Understanding of chemical synthesis, purification techniques, formulation, packaging, and inventory management.
• Experience with computerized inventory management and electronic notebook systems.
• Proficiency in statistical tools (e.g., Excel and JMP).
• Strong scientific problem-solving skills.
• Experience with pharmaceutical analysis or production preferred.
• Strong project management skills, with managing a network of external vendors preferred.

Skills

• Experience with the science of reference standards preferred.
• Pharmaceutical analysis or production experience preferred.
• Strong project management skills, with managing a network of external vendors preferred.

Benefits

Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Pay

The anticipated wage for this position is $65,250 - $169,400.

Schedule

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).