Senior Manager, CMC Process Development

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. (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
• 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
• Wisconsin pay range $150,000 — $165,000 USD
• 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.
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