Biologics API Manufacturing Scientist – Technical Services

BioSpace; Indianapolis (IN); On-site; USD 68,000 - 174,000; Full time

Benefits offered by this job

Relocation assistance

Annual bonus

401(k) plan

Comprehensive benefits

Job summary

Lilly in Indianapolis is seeking an API-EM TS/MS Scientist to provide technical expertise for external manufacturing of biologics. You will support process monitoring, issue response, and improvements across contract manufacturers, ensuring compliance with cGMP and global standards.

The role requires a strong manufacturing background, cross-functional collaboration, and ability to influence external partners while maintaining regulatory alignment.

Qualifications

• Bachelor-level scientific degree in biotech, chemistry, biochemistry, biology, pharmacy or engineering.
• 3+ years hands-on experience in pharmaceutical manufacturing and regulatory expectations.
• Authorized to work in the United States on a full-time basis; no work visa sponsorship provided.

Responsibilities

• Provide technical oversight for biologics manufacturing processes.
• Lead resolution of technical issues including control strategy and manufacturing.
• Use excellent communication skills to manage internal and external relationships.
• Build and maintain relationships with development and central technical organizations.
• Ensure proper characterization of processes and products with documented measures and specifications.
• Ensure processes are compliant, capable, in control, and maintained in a validated state.
• Justify and document validation state with data on process capability.
• Influence and implement the network technical agenda and drive continuous improvement.
• Maintain biologic processes in a state of compliance with US and global regulations.
• Understand scientific principles required for manufacturing intermediates and drug substances.

Skills

Regulatory understanding

Data management

Cross-functional collaboration

Effective communication

Project management

Education

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

Job description

Lilly in Indianapolis is seeking an API-EM TS/MS Scientist to provide technical expertise for external manufacturing of biologics. You will support process monitoring, issue response, and improvements across contract manufacturers, ensuring compliance with cGMP and global standards.

The role requires a strong manufacturing background, cross-functional collaboration, and ability to influence external partners while maintaining regulatory alignment.