Senior Manager, CMC Process Development - Late-Phase

Doist; Verona (WI); On-site; USD 150,000 - 165,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. seeks a Senior Manager, CMC Process Development to lead raw material manufacturing, regulatory classification, and supply for oligonucleotide programs.

This full-time onsite role is based in Verona, WI, coordinating with CMOs and vendors while guiding RSM strategy and regulatory filings. The candidate will oversee process chemistry oversight, impurity control, and transfer to kilo-scale manufacturing, with strong leadership of a PD team and collaboration across

Qualifications

• Ph.D. in Organic Chemistry or related field with 5+ years of relevant experience (MS = 10+; BS = 12+).
• Demonstrated expertise with organic chemistry theory and practice.
• Experience with pharmaceutical drug substance development and processes.
• Experience with regulatory interactions (CMC/starting materials) and GMP.
• Familiarity with GMP requirements for raw material and API manufacturing.
• Prior people management or team leadership experience.

Responsibilities

• Define regulatory starting material designations for synthetic routes with Regulatory Affairs.
• Author and review RSM justification sections for regulatory filings (IND/IMPD/NDA/MAA).
• Evaluate route changes for impact on RSM designation and regulatory strategy.
• Provide technical review of synthetic routes, process chemistry, and impurity control.
• Assess raw materials specifications for fitness for intended use.
• Support tech transfer of processes from development to kilo-scale manufacturing.
• Manage day-to-day relationships with CMOs and suppliers; act as technical contact.
• Lead supplier onboarding for raw and starting materials.
• Mentor and develop PD scientists; oversee workload.
• Prepare technical reports, SOPs, and procedures.
• Approve technical documentation and workflows.
• Collaborate with cross-functional teams to meet project goals.
• Coordinate with third-party vendors and CDMOs to meet deliverables.
• Monitor and report progress within timelines.

Skills

Organic chemistry theory & practice

Regulatory interactions

People management

GMP knowledge

Drug substance development

Vendor/CMO management

ICH Q11 familiarity

Education

Ph.D. in Organic Chemistry

M.S. in related field

B.S. in related field

Tools

ICH Q11 guidelines

Job description

Arrowhead Pharmaceuticals, Inc. seeks a Senior Manager, CMC Process Development to lead raw material manufacturing, regulatory classification, and supply for oligonucleotide programs.

This full-time onsite role is based in Verona, WI, coordinating with CMOs and vendors while guiding RSM strategy and regulatory filings. The candidate will oversee process chemistry oversight, impurity control, and transfer to kilo-scale manufacturing, with strong leadership of a PD team and collaboration across