The Group Manager, PDO is accountable for end-to-end alignment of Arrowhead products from preclinical through commercial phases, providing leadership to cross-functional CMC teams and overseeing internal and external CMC activities for program timelines, quality standards, and regulatory requirements. Partners-facing point of contact and primary contact for CMOs and CROs supporting development, analysis, manufacturing, packaging, and labeling.
Responsibilities:
- Act as primary project point of contact; facilitate internal/external communication for CMC development, analytical, manufacturing, packaging, and labeling
- Maintain project status awareness; tailor communications for leadership and stakeholders/partners
- Manage budget, timeline, quality, and deliverables for projects and vendors
- Escalate risks, drive scenario planning, and recommend actions to leadership
- Maintain/expand project tracking tools (e.g., Smartsheet, Excel, Power BI); analyze metrics and recommend improvements
- Interface with cross-functional teams (Chemistry, Engineering, Analytical, Quality) on partner development/manufacturing
- Track/manage/negotiates proposals; draft RFPs with SME and Legal support
- Steer contract and agreement alignment (contracts, supply agreements, NDAs, purchase orders)
- Track vendor invoices with Finance; develop/collect performance metrics
- Lead meetings, vendor visits, and conference calls; facilitate internal consensus
- Drive vendor business reviews; support vendor management as needed
- Assist with CMC outsourcing budget; coach/mentor direct reports; develop training materials and onboarding
- Collaborate with Alliance Management on partnership goals
- Other duties as assigned
Requirements:
- Bachelorโs degree in a scientific field (e.g., Chemistry, Chemical Engineering, Biochemistry, Biotechnology)
- 8+ years increasing responsibility in pharma/CMO/CRO (including direct report experience)
- 5+ years project management managing clients/partners/vendors
- Knowledge of GLP, GMP, and regulatory guidance for pharma manufacturing/testing
- Strong MS Office skills (Outlook, Excel, PowerPoint, Word)
- Excellent verbal and written communication; matrix teamwork
- Highly motivated team player; detail-oriented, organized, self-starter
Preferred:
- Masterโs degree (related science)
- GLP/GMP lab or manufacturing experience
- Late-stage CMC drug development/commercialization experience
- Project Management Certification; ERP system experience
Pay Range: $125,000 USD - $135,000 USD
Benefits: competitive salaries and an excellent benefits package.
Application instruction: Candidates must have current, valid authorization to work in the country where the role is located.