Senior Biologics DP Engineer & Tech Transfer Lead

BioSpace; Indianapolis (IN); On-site; USD 129,000 - 209,000; Full time

Job summary

Lilly in Indianapolis, Indiana is seeking a Advisor or Senior Advisor, Engineering, Biologics Drug Product Development to define parenteral manufacturing processes and lead cross-functional collaboration. The role drives tech transfer, process qualification, regulatory submissions, and pioneering technologies like ADC, mRNA LNP.

Requires advanced degree and extensive biologics knowledge. This is a high-impact, full-time position with competitive compensation and comprehensive benefits; actual

Qualifications

• PhD with 2+ years of industry experience in pharmaceutical development or manufacturing.
• MS with 10+ years of industry experience in pharmaceutical development or manufacturing.
• BS with 12+ years of industry experience in pharmaceutical development or manufacturing.
• Extensive knowledge and deep understanding of biologics parenteral product development.
• Deep understanding of cGMP requirements, ICH and regulatory guidelines.

Responsibilities

• Define parenteral drug product clinical manufacturing processes for clinical manufacturing.
• Collaborate with cross-functional stakeholders to develop process control strategies and criteria.
• Lead tech transfer, scale-up, and mentor scientists to define manufacturing parameters.
• Review regulatory documents for IND, BLA and NDA and respond to inquiries.
• Drive process qualification and control strategy and address technical gaps.

Skills

Biologics parenteral dev

cGMP knowledge

Regulatory guidelines

Stakeholder management

ADC/mRNA LNP experience

Statistics & data mgmt

Communication skills

Education

Engineering degree (PhD/MS/BS)

Job description

Lilly in Indianapolis, Indiana is seeking a Advisor or Senior Advisor, Engineering, Biologics Drug Product Development to define parenteral manufacturing processes and lead cross-functional collaboration. The role drives tech transfer, process qualification, regulatory submissions, and pioneering technologies like ADC, mRNA LNP.

Requires advanced degree and extensive biologics knowledge. This is a high-impact, full-time position with competitive compensation and comprehensive benefits; actual