The PositionWe 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
Wisconsin pay range
$150,000-$165,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
