Lead Scientist, Early-Phase Drug Substance Process

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 120,000 - 160,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI, is seeking a Process Chemistry Scientist to provide technical oversight for externally manufactured drug substance programs within the CMC function.

The role leads documentation for external batches and monitors batch data to support process improvements. The successful candidate will have a strong GMP background, experience with API manufacturing and early-phase drug substance production, and will partner with Analytical Development, Regulatory,

Qualifications

• Master’s degree with 5+ years industry experience; or Bachelor’s with 8+ years experience.
• Experience in pharmaceutical/biotech process development or drug substance manufacturing.
• Experience with cGMP and regulatory documentation reviews.

Responsibilities

• Provide technical oversight for externally manufactured drug substance programs.
• Review master batch records, executed batch records, and batch-disposition docs.
• Track key process parameters and trends for lifecycle improvements.
• Lead root-cause investigations and implement corrective actions.
• Coordinate with CMOs and Process Development for tech transfer.
• Ensure compliance with cGMP and safety requirements.

Skills

GMP documentation review

Data analysis

Root-cause investigations

Cross-functional collaboration

Technical communication

Problem solving

Process development

Education

Master’s degree in Chemistry/Biochemistry/Chemical Engineering/Pharmaceutical Sciences

Bachelor’s degree with 8+ years industry experience

Job description

Arrowhead Pharmaceuticals, Inc. in Madison, WI, is seeking a Process Chemistry Scientist to provide technical oversight for externally manufactured drug substance programs within the CMC function.

The role leads documentation for external batches and monitors batch data to support process improvements. The successful candidate will have a strong GMP background, experience with API manufacturing and early-phase drug substance production, and will partner with Analytical Development, Regulatory,