Senior/Principal Scientist – Peptide Technical Services & Manufacturing Science (TS/MS), API External Manufacturing

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Peptide/oligonucleotide manufacturing

Process stewardship

Process validation

Regulatory support

GMP compliance

Job summary

Lilly is seeking a Senior/Principal Scientist for API External Manufacturing in Indianapolis. You will oversee peptide and oligonucleotide manufacturing processes, lead issue resolution, and support transfers and validation in a cGMP environment.

Collaborating with external CMOs, you will contribute to regulatory documentation and drive continuous improvements while ensuring global regulatory compliance.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmacy, or Engineering.
• 3+ years of experience in pharmaceutical manufacturing.
• Knowledge of regulatory expectations and process monitoring.

Responsibilities

• Provide technical oversight for peptide and oligonucleotide manufacturing.
• Lead issue resolution and troubleshooting in production.
• Support process transfer and validation activities.
• Ensure compliance with cGMPs and global regulations, and contribute to regulatory documentation.
• Manage relationships with external contract manufacturers.
• Perform process characterization and data-driven optimization.
• Drive continuous improvement initiatives.

Skills

Peptide manufacturing

Oligonucleotide manufacturing

Regulatory knowledge

Process monitoring

Cross-functional communication

Education

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

Job description

Role

Senior/Principal Scientist in API External Manufacturing within Lilly's Technical Services/Manufacturing Sciences team, specializing in Peptides and Oligonucleotides (TIDES).

Responsibilities

• provide technical oversight for peptide/oligonucleotide manufacturing
• lead issue resolution
• support process transfer and validation
• ensure compliance with cGMPs and global regulations, and contribute to regulatory documentation
• Manage relationships with external contract manufacturers
• perform process characterization
• drive continuous improvement initiatives

Requirements

• Bachelor's in Chemistry, Biochemistry, Biology, Pharmacy, or Engineering
• 3+ years in pharmaceutical manufacturing
• knowledge of regulatory expectations and process monitoring

Preferred

• experience with regulatory requirements
• project management
• cross-functional communication

HighValue

• peptide/oligonucleotide manufacturing
• process stewardship
• process validation
• regulatory support
• GMP compliance

WorkSetup

onsite Indianapolis, IN; some travel; possible off-shift work to support 24/7 operations.