Biologics API-EM Scientist — External Manufacturing

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

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Well-being programs

Job summary

Lilly seeks an API-EM Scientist to support biologics manufacturing through external contract manufacturers, ensuring performance aligns with global quality standards. The role requires cross-functional collaboration with development, QC/QA, and site management to maintain compliant processes.

The position emphasizes regulatory understanding, documentation rigor, and the ability to drive continuous improvement in a 24/7 manufacturing environment in Indianapolis, IN.

Qualifications

• 3+ years of hands-on experience in pharmaceutical manufacturing and knowledge of regulatory expectations.
• Authorized to work in the United States on a full-time basis; sponsor unlikely.
• Technical expertise to support biologics manufacturing and external contract manufacturers.

Responsibilities

• Provide technical oversight for biologics manufacturing processes.
• Lead resolution of technical issues, including control strategy.
• Communicate effectively with internal and external partners.
• Build relationships with development and central technical organizations.
• Document process descriptions, measures, and specifications with justification.
• Ensure processes are compliant, in control, and validated or qualified.
• Assess validation data to demonstrate process capability.
• Drive continuous improvement across the network.

Skills

Biotech/pharmaceutical manufacturing

Regulatory compliance knowledge

Data management

Cross-functional collaboration

Education

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

Job description

Lilly seeks an API-EM Scientist to support biologics manufacturing through external contract manufacturers, ensuring performance aligns with global quality standards. The role requires cross-functional collaboration with development, QC/QA, and site management to maintain compliant processes.

The position emphasizes regulatory understanding, documentation rigor, and the ability to drive continuous improvement in a 24/7 manufacturing environment in Indianapolis, IN.