Group Manager, CMC Project Management

Responsibilities

• Act as primary point of contact for projects, facilitating communication between internal and external team members for CMC development, analytical, manufacturing, packaging, and labeling activities with minimal support of direct management.
• Maintain a clear understanding of project status and tailor communications appropriately for Arrowhead leadership, relevant stakeholders, and partner companies.
• Manage budget, timeline, quality and deliverables for each project and vendor.
• Escalate risks, drive scenario planning, and present recommendations to leadership teams.
• Analyze project metrics and prepare recommendations for leadership.
• Interface with cross-functional project team (Chemistry, Engineering, Analytical, Quality) on partner development and manufacturing activities.
• Track, manage, and negotiate new proposals and draft RFPs with support from technical SME’s and Legal.
• Steer alignment among technical SME’s, Sourcing & Supplier Management, Legal, and Finance on contracts, supply agreements, confidentiality agreements, and purchase orders for new and existing vendors.
• Track vendor invoices and collaborate with Finance to process payments.
• Develop, collect, and maintain performance metrics for internal and external partners.
• Lead project meetings, vendor/partner visits, and conference calls.
• Facilitate internal discussions to obtain team consensus and decisions.
• Drive business review meetings with vendors with support from Sourcing & Supplier Management.
• Aid in developing and reviewing CMC outsourcing budget.
• Coach and mentor direct reports in the creation of personal goals, development, and performance improvement.
• Generate, maintain, and approve training materials and support onboarding of new team members.
• Collaborate with Alliance Management on partnership goals.

Requirements

• Bachelor’s degree in a scientific field such as Chemistry, Chemical Engineering, Biochemistry, Biotechnology.
• Eight years of increasing responsibility in a pharmaceutical company, contract manufacturing organization or contract research organization including direct report experience.
• Minimum five years in a project management role with experience managing clients, partners, and/or vendors.
• Knowledge of applicable GLP, GMP, and regulatory guidance for pharmaceutical manufacturing and testing.
• Strong MS Office skills (Outlook, Excel, PowerPoint, and Word).
• Excellent verbal and written communication skills.
• Ability to work with diverse professionals in a matrix environment.
• Highly motivated team player willing to contribute to a growing biotech organization.
• A detail oriented, organized, self-starter who endeavors to anticipate problems and seeks opportunities to grow the role and responsibilities at Arrowhead.
• Preferred: Master's degree in Chemistry, Chemical Engineering, Biochemistry or related science field.
• GLP or GMP Laboratory or Manufacturing experience.
• Experience with late-stage CMC drug development and commercialization activities.
• Project Management Certification.
• ERP system experience.