Senior Scientist, Peptide Manufacturing & Process

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 66,000 - 172,000; Full time

Job summary

Lilly in Indianapolis, IN is seeking an API-EM TS/MS Sr. Scientist to provide technical and scientific expertise in external manufacturing environments for peptide drug substance. You will monitor processes, troubleshoot issues, and ensure compliance to global quality standards with external contract manufacturers.

The role requires knowledge of cGMPs, regulatory guidance, and cross-functional collaboration to meet technical objectives while supporting 24/7 operations and mentoring peers.

Qualifications

• Bachelor's in Chemistry, Biochemistry, Biology, Pharmacy or Engineering.
• 3+ years of pharmaceutical manufacturing experience with regulatory expectations.
• Knowledge of cGMPs and global regulatory manufacturing guidance.

Responsibilities

• Provide technical oversight for peptide manufacturing processes.
• Lead resolution of technical issues including control strategy and manufacturing.
• Communicate effectively to manage internal and external relationships.
• Build and maintain relationships with development and central technical organizations.
• Ensure proper characterization of processes and documentation of measures and specifications.
• Ensure processes are compliant, in control, and maintained in validated state.
• Document validation status with data supporting process capability.
• Influence and implement the network technical agenda and drive continuous improvement.
• Maintain peptide processes in compliance with US and global regulations.
• Coach and mentor peers and other scientists.

Skills

Process monitoring

Regulatory knowledge

Communication

Cross-functional collaboration

Mentorship

Education

Bachelor's degree in Chemistry/Biochemistry/Biology/Pharmacy or Engineering

Tools

cGMP understanding

Regulatory documentation systems

Job description

Lilly in Indianapolis, IN is seeking an API-EM TS/MS Sr. Scientist to provide technical and scientific expertise in external manufacturing environments for peptide drug substance. You will monitor processes, troubleshoot issues, and ensure compliance to global quality standards with external contract manufacturers.

The role requires knowledge of cGMPs, regulatory guidance, and cross-functional collaboration to meet technical objectives while supporting 24/7 operations and mentoring peers.