Senior Manager, CMC Process Development – Onsite Verona

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Excellent benefits package

Job summary

Arrowhead Pharmaceuticals, Inc. seeks a Senior Manager, CMC Process Development for our Late Phase Development team in Verona, WI. The role leads regulatory starting material strategy, oversees small molecule synthesis, and manages outsourcing with CMOs and raw material suppliers.

The ideal candidate combines strong chemistry fundamentals with regulatory acumen and proven vendor management experience; this is a full-time onsite role requiring collaboration across cross-functional teams.

Qualifications

• Demonstrated expertise with organic chemistry theory and practice.
• Experience in pharmaceutical drug substance development and processes.
• Regulatory interactions related to CMC/starting materials preferred.

Responsibilities

• Define and defend regulatory starting material designations for synthetic routes with Regulatory Affairs (ICH Q11).
• Author and review RSM justification sections for regulatory filings (IND/IMPD, NDA, MAA, etc.).
• Evaluate synthetic route changes for impact on RSM designation and regulatory strategy.
• Provide technical review of synthetic routes, process chemistry, and impurity control strategies for small molecules.
• Manage day-to-day relationships with CMOs and raw material suppliers; act as primary technical contact.

Skills

Regulatory knowledge

Vendor/CMO management

Organic chemistry theory

Education

PhD in Organic Chemistry

MS in related field

BS in related field

Job description

Arrowhead Pharmaceuticals, Inc. seeks a Senior Manager, CMC Process Development for our Late Phase Development team in Verona, WI. The role leads regulatory starting material strategy, oversees small molecule synthesis, and manages outsourcing with CMOs and raw material suppliers.

The ideal candidate combines strong chemistry fundamentals with regulatory acumen and proven vendor management experience; this is a full-time onsite role requiring collaboration across cross-functional teams.