BRD Analytical Development Director

BioSpace; Indianapolis (IN); On-site; USD 140,000 - 218,000; Full time

Benefits offered by this job

Company bonus

401(k) and pension

Medical, dental, vision benefits

Paid time off

Job summary

Lilly, headquartered in Indianapolis, IN, seeks experienced professionals to lead analytical sciences across drug substances and products. The role supports regulatory submissions, IND/CTA and BLA/NDA activities within a multidisciplinary team and external partners.

You will mentor staff and drive optimization of modalities from peptide to gene therapies as needed. The position is onsite in Indianapolis with travel up to 15% and a comprehensive benefits program.

Qualifications

• Ph.D. in Analytical Chemistry or Bioanalytical Chemistry with 5+ years in the pharmaceutical industry.
• Experience leading analytical efforts for drug substance/product development and commercialization; introduced new methodologies.
• Experience developing global regulatory strategies and authoring regulatory submissions.

Responsibilities

• Lead analytical efforts for drug substance/product development and regulatory submissions.
• Develop analytical methods, specifications, and stability studies.
• Author IND/CTA, BLA/NDA/MAA, RtQ and respond to regulatory questions.
• Transfer technology to CRO/CMO networks and Lilly sites.
• Mentor and develop scientific staff and drive knowledge sharing.

Skills

Analytical chemistry

Pharma development

Regulatory submissions

Leadership

Mentoring

Education

Ph.D. in Analytical/Bioanalytical Chemistry

B.S. in Chemistry with 15+ years

M.S. in Chemistry with 10+ years

Job description

Lilly, headquartered in Indianapolis, IN, seeks experienced professionals to lead analytical sciences across drug substances and products. The role supports regulatory submissions, IND/CTA and BLA/NDA activities within a multidisciplinary team and external partners.

You will mentor staff and drive optimization of modalities from peptide to gene therapies as needed. The position is onsite in Indianapolis with travel up to 15% and a comprehensive benefits program.