Senior Advisor, Biologics Drug Product Engineering

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

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Healthcare benefits

Job summary

Lilly is seeking a Advisor/Senior Advisor, Engineering, Biologics Drug Product Development in Indianapolis. You will define parenteral manufacturing processes for clinical development, lead tech transfer, and coordinate cross-functional teams to ensure regulatory submissions are robust and timely.

Responsibilities include developing process control strategies, collaborating with RA, analytical, manufacturing services, and external CDMOs, and staying at the forefront of new technologies in

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.

Responsibilities

• Define parenteral drug product clinical manufacturing processes.
• Develop manufacturing process control strategies and capability criteria.
• Lead tech transfer and manufacturing process design.
• Author regulatory submissions and related documents (IND/BLA/NDA).
• Collaborate with internal/external stakeholders to accelerate development.
• Support regulatory inquiries and drive regulatory strategy.

Skills

Parenteral DP development

Regulatory submissions

Cross-functional leadership

Process development

Statistical data management

Education

PhD

MS

BS

Job description

Lilly is seeking a Advisor/Senior Advisor, Engineering, Biologics Drug Product Development in Indianapolis. You will define parenteral manufacturing processes for clinical development, lead tech transfer, and coordinate cross-functional teams to ensure regulatory submissions are robust and timely.

Responsibilities include developing process control strategies, collaborating with RA, analytical, manufacturing services, and external CDMOs, and staying at the forefront of new technologies in