Senior Manager, CMC Process Development

About the role

Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. We are seeking a Senior Manager, CMC Process Development on our Late Phase Development team to lead the strategy and execution of raw material manufacturing, regulatory classification, and supply for our oligonucleotide programs.

Responsibilities

• Define and defend regulatory starting material designations for synthetic routes in collaboration with Regulatory Affairs, in alignment with ICH Q11
• Author and review RSM justification sections for regulatory filings (IND/IMPD, NDA, MAA, etc.)
• Evaluate synthetic route changes for their impact on RSM designation and regulatory strategy
• Provide technical review and oversight of synthetic routes, process chemistry, and impurity control strategies for small molecules
• Assess raw material and starting material specifications to ensure fitness for intended use and consistency with quality target product profiles
• Support technology transfer of synthetic processes from development to kilo-scale manufacturing
• Manage day-to-day relationships with CMOs and raw material/starting material suppliers, serving as the primary technical point of contact
• Lead supplier selection onboarding for raw materials and starting materials
• Manage PD scientists and assists in the prioritization and management of work flow
• Provides leadership, technical guidance, and mentoring and development of PD scientists
• Prepare technical reports, presentations, SOPs, Work Instructions, and procedures
• Approve technical documentation and workflows
• Work with cross-functional teams (Process Development, QA, Regulatory, Discovery, AD, Manufacturing, PM, and others as needed) to develop and meet project goals and deliverables
• Work with third party vendors and CDMOs to meet project deliverables
• Monitor and report progress of PD project deliverables within agreed project timelines

Requirements

• Ph.D. in Organic Chemistry or a related field with 5+ years, M.S. with 10+ years, or B.S. with 12+ years of relevant industry experience in chemistry
• Demonstrated expertise with organic chemistry theory and practice
• Demonstrated experience with pharmaceutical drug substance development and processes

Preferred

• PhD or Master's Degree
• Experience with regulatory interactions (meetings, information requests, filings) related to CMC/starting materials
• Familiarity with GMP requirements for raw material and API manufacturing
• Prior people management or team leadership experience

Pay

The pay range for this role in Wisconsin is $150,000 USD - $165,000 USD. Arrowhead provides competitive salaries and an excellent benefit package.

Schedule

This role is full-time onsite, 5 days a week in Verona, WI.