Senior Manager, CMC Process Development

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. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

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. This individual will own the regulatory starting material (RSM) strategy, provide technical oversight of small molecule synthesis, and manage outsourced manufacturing relationships with contract manufacturing organizations (CMOs) and raw material suppliers. The ideal candidate combines strong chemistry fundamentals with regulatory acumen and proven vendor/CRO/CMO management experience.

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

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

• Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.