Senior Manager, Process Development
Arrowhead Pharmaceuticals
August 06, 2026
On-site
Madison, WI
$150,000 - $165,000 USD yearly
Operations
The Position:
Senior Manager, CMC Process Development (Late Phase Development) to lead the strategy and execution of raw material manufacturing, regulatory classification, and supply for oligonucleotide programs. Own regulatory starting material (RSM) strategy, provide technical oversight of small molecule synthesis, and manage outsourced manufacturing relationships with CMOs and raw material suppliers.
Responsibilities:
- Define and defend regulatory starting material designations (aligned with ICH Q11)
- Author/review RSM justification sections for IND/IMPD, NDA, MAA, etc.
- Evaluate synthetic route changes’ impact on RSM designation and regulatory strategy
- Provide technical oversight of synthetic routes, process chemistry, and impurity control
- Assess raw material/starting material specifications for fitness and consistency with quality targets
- Support technology transfer from development to kilo-scale manufacturing
- Manage day-to-day relationships with CMOs and raw material/starting material suppliers (primary technical point of contact)
- Lead supplier selection onboarding
- Manage PD scientists and workflow prioritization; provide mentoring and guidance
- Prepare/approve technical reports, presentations, SOPs, work instructions, and procedures
- Collaborate cross-functionally to meet project goals and deliverables
- Work with third-party vendors/CDMOs and monitor/report PD deliverable progress
Requirements:
- PhD in Organic Chemistry (5+ years) OR MS (10+ years) OR BS (12+ years) in relevant industry chemistry
- Demonstrated expertise in organic chemistry theory and practice
- Demonstrated experience with pharmaceutical drug substance development and processes
Preferred:
- PhD or Master’s Degree
- Experience with regulatory interactions related to CMC/starting materials
- Familiarity with GMP requirements for raw materials and API manufacturing
- Prior people management/team leadership experience
Wisconsin pay range: $150,000–$165,000. Candidates must have current, valid authorization to work in the role’s location.
Senior Manager, CMC Process Development (Late Phase Development) to lead the strategy and execution of raw material manufacturing, regulatory classification, and supply for oligonucleotide programs. Own regulatory starting material (RSM) strategy, provide technical oversight of small molecule synthesis, and manage outsourced manufacturing relationships with CMOs and raw material suppliers.
Responsibilities:
- Define and defend regulatory starting material designations (aligned with ICH Q11)
- Author/review RSM justification sections for IND/IMPD, NDA, MAA, etc.
- Evaluate synthetic route changes’ impact on RSM designation and regulatory strategy
- Provide technical oversight of synthetic routes, process chemistry, and impurity control
- Assess raw material/starting material specifications for fitness and consistency with quality targets
- Support technology transfer from development to kilo-scale manufacturing
- Manage day-to-day relationships with CMOs and raw material/starting material suppliers (primary technical point of contact)
- Lead supplier selection onboarding
- Manage PD scientists and workflow prioritization; provide mentoring and guidance
- Prepare/approve technical reports, presentations, SOPs, work instructions, and procedures
- Collaborate cross-functionally to meet project goals and deliverables
- Work with third-party vendors/CDMOs and monitor/report PD deliverable progress
Requirements:
- PhD in Organic Chemistry (5+ years) OR MS (10+ years) OR BS (12+ years) in relevant industry chemistry
- Demonstrated expertise in organic chemistry theory and practice
- Demonstrated experience with pharmaceutical drug substance development and processes
Preferred:
- PhD or Master’s Degree
- Experience with regulatory interactions related to CMC/starting materials
- Familiarity with GMP requirements for raw materials and API manufacturing
- Prior people management/team leadership experience
Wisconsin pay range: $150,000–$165,000. Candidates must have current, valid authorization to work in the role’s location.