Manufacturing Scientist - LP1 Peptide Synthesis

Hispanic Alliance for Career Enhancement; Lebanon (IN); On-site; USD 60,000 - 95,000; Full time

Job summary

An established industry player in healthcare is seeking a Manufacturing Scientist for its new greenfield facility in Lebanon, IN. This role offers a unique opportunity to contribute to the startup of advanced manufacturing processes for API molecules. You will be part of a dedicated team focused on enhancing process control, yield, and productivity in a compliant environment. Your expertise will help shape the future of reliable medicine supply, ensuring that quality standards are met through innovative solutions and collaborative efforts. If you are passionate about making a difference in global health, this position is perfect for you.

Qualifications

• Bachelor's in Chemistry or related field with 3 years of cGMP experience.
• Master's degree with at least 1 year of relevant experience.

Responsibilities

• Execute technical projects to improve process control and productivity.
• Develop metrics to assess process variability and capability.
• Design experiments with clear objectives.

Skills

Analytical Skills

Communication Skills

Interpersonal Skills

Creativity

Initiative

Education

Bachelor's in STEM

Master's in STEM

Tools

cGMP manufacturing

Technical Documentation

Process Control

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 35,000 employees worldwide work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We prioritize our work and put people first. We're seeking individuals committed to improving lives globally.

Lilly is constructing an advanced manufacturing facility for API molecules in Lebanon, IN. This site represents our largest investment in manufacturing capacity, supporting current and future products, including new modalities. This is a unique opportunity to join the startup team for a greenfield manufacturing site, helping to establish processes and systems for successful GMP manufacturing operations.

Organization Overview:

The Manufacturing Scientist is part of the TSMS (Technical Services/Manufacturing Science) team, providing technical support for reliable, compliant API manufacturing. This role supports the Manufacturing Process Team, ensuring safe and reliable medicine supply. Responsibilities include executing technical projects to improve process control, yield, purity, and productivity, and conducting research and experiments at laboratory scale for process improvements and troubleshooting.

Key Responsibilities:

1. Understand scientific principles of manufacturing intermediates and bulk drug substances, including chemistry and equipment interactions.
2. Execute technical projects to enhance process control, yield, purity, and productivity.
3. Support preparation of technical documents such as reports, change controls, regulatory submissions, deviation investigations, validation protocols, and processing records.
4. Develop and monitor metrics to assess process variability and capability.
5. Validate and document manufacturing processes and cleaning processes using data to demonstrate capability.
6. Ensure accurate instructions and process flow documents describe the process and control strategies.
7. Design experiments with clear objectives.
8. Investigate deviations to ensure product quality.

Basic Requirements:

• Bachelor's in STEM (Chemistry preferred) with at least 3 years in cGMP manufacturing, or master's with 1 year experience.

Additional Preferences:

• Knowledge of peptide synthesis.
• Experience in API manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.
• Familiarity with cGMP environment and terminology.
• Strong analytical, communication, and interpersonal skills.
• Ability to work independently and in diverse teams.
• Creativity and initiative for process improvements.
• Mentoring skills and flexibility to meet business needs.

Lilly is committed to diversity and inclusion. If accommodations are needed during the application process, please complete the accommodation request form. We are an EEO employer and do not discriminate based on protected statuses.