Director, BRD Analytics & Development

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

Benefits offered by this job

Company bonus

401(k) and retirement benefits

Medical, dental, vision benefits

Flexible benefits

Onsite work at LTC-N Indy

Job summary

Lilly in Indianapolis, IN invites applications for an experienced analytical scientist to lead drug substance and drug product analytical efforts. The role supports clinical trials, regulatory submissions, and new product commercialization within a multidisciplinary team.

The role requires a PhD in Analytical Chemistry or related field with 5+ years in pharma, plus experience with IND/CTA and BLA/NDA processes. Onsite work at Lilly Technology Center-North is expected.

Qualifications

• Ph.D. or equivalent with 5+ years in pharma analytics or related field.
• Experience leading analytical efforts for drug substance and/or drug product development.
• Experience authoring regulatory submissions and responding to regulatory questions.
• Mentored scientific staff and led cross-functional teams.

Responsibilities

• Lead analytical efforts for drug substance and/or drug product development.
• Develop analytical methods and justify specifications for regulatory submissions.
• Design stability studies and support IND/CTA and BLA/NDA submissions.
• Provide technical guidance and transfer methods to CRO/CMO and Lilly sites.
• Collaborate with Discovery, Development, and Manufacturing to deliver data for trials.

Skills

Strong communication

Organizational skills

Leadership skills

Education

Ph.D. in Analytical Chemistry or Bioanalytical Chemistry

B.S. in Chemistry with 15+ years of experience

M.S. in Chemistry with 10+ years of experience

Job description

Lilly in Indianapolis, IN invites applications for an experienced analytical scientist to lead drug substance and drug product analytical efforts. The role supports clinical trials, regulatory submissions, and new product commercialization within a multidisciplinary team.

The role requires a PhD in Analytical Chemistry or related field with 5+ years in pharma, plus experience with IND/CTA and BLA/NDA processes. Onsite work at Lilly Technology Center-North is expected.