Sr. Scientist Peptides - Person in Plant

Eli Lilly and Company; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a TSMS Sr. Scientist specializing in peptides manufacturing. This role offers the opportunity to provide technical leadership and ensure the quality and safety of life-changing medicines. You will collaborate with contract manufacturers and internal teams, utilizing your expertise in GMP regulations and process optimization. Ideal candidates will have a solid foundation in chemistry or biochemistry, along with proven experience in pharmaceutical manufacturing. Join a diverse team dedicated to making a global impact and driving innovation in healthcare.

Qualifications

• 5+ years of experience in GMP pharmaceutical manufacturing.
• Strong leadership and collaboration skills required.

Responsibilities

• Oversee process monitoring and troubleshoot issues.
• Drive continuous improvement initiatives in manufacturing.

Skills

GMP pharmaceutical manufacturing

Process optimization

Root cause analysis

Team leadership

Regulatory knowledge

Communication skills

Education

Bachelor’s in Chemistry or Biochemistry

Job description

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 work worldwide to discover and deliver life-changing medicines, improve disease understanding and management, and give back through philanthropy and volunteerism. We prioritize our work and people, seeking those committed to bettering lives globally.

Position: TSMS Sr. Scientist Peptides Person in Plant - APIEM

This role reports to the TSMS Director – Peptides API EM and provides technical leadership in collaboration with API EM contract manufacturer personnel to ensure reliable supply and commercialization of medicines, emphasizing safety and quality. Responsibilities include:

1. Developing and maintaining process knowledge to ensure proper execution of product, process, and operational control strategies at the Contract Manufacturer (CM).
2. Interacting with CM personnel to ensure reliable supply through proper process execution.
3. Participating in technical transfer, process validation, and data monitoring with internal or external resources.
4. Adhering to Lilly’s standards (Red Book) during interactions with CMs.

Key Objectives/Deliverables:

The candidate will oversee process monitoring, troubleshoot issues, and implement improvements, requiring a strong understanding of manufacturing principles and Lilly systems to uphold standards with external CMs.

The role demands knowledge of cGMPs, global regulatory guidance, and industry standards, with cross-functional collaboration to meet technical goals.

Build and Sustain Process Team Relationships

• Leverage experience with unit operation control to contribute to the Lilly/CM Joint Process Team.
• Use excellent communication skills to manage relationships internally and externally.
• Build relationships with development and technical teams.
• Promote team spirit, coaching, and mentoring.

Develop and Sustain Process Knowledge

• Provide oversight for peptide manufacturing processes.
• Ensure compliance, control, and validation of processes.
• Maintain process knowledge infrastructure, including validated monitoring tools.
• Track key process parameters (CPPs, rOPPs, IPCs).

Provide Process Support

• Lead resolution of technical issues and process characterization.
• Document process descriptions, measures, and justifications.
• Validate processes with supporting data.
• Identify systemic production issues and lead root cause analysis and CAPAs.

Process Optimization & Continuous Improvement

• Drive technical agenda and continuous improvement initiatives.
• Ensure peptide processes comply with US and global regulations.
• Support development and analysis of process improvements.
• Identify cost reduction opportunities and bottlenecks.
• Optimize cycle time, loading, and yield.

Basic Requirements:

• Bachelor’s in Chemistry or Biochemistry.
• 5+ years of GMP pharmaceutical manufacturing experience and regulatory knowledge.
• Proven team leadership and collaboration skills.
• Ability to manage priorities and communicate effectively.

Preferred Qualifications:

• Experience with root cause analysis and problem solving.
• Knowledge of regulatory requirements and data management.
• Enthusiasm, flexibility, and influence skills.
• Project management experience.

Additional Information:

• Standard schedule is Monday-Friday, with potential off-hours for global support.
• Work involves entering manufacturing and lab areas with PPE requirements.
• Some travel may be required.

Lilly is committed to diversity and inclusion. If accommodations are needed during the application process, please complete the workplace accommodation request form. Lilly does not discriminate based on legally protected statuses.