Group Manager, CMC Project Management

Job Description

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

The Group Manager, PDO is a member of a team charged with ownership of end-to-end alignment of Arrowhead products from preclinical through commercial phases. This role is accountable for assigned projects and provides leadership to cross-functional CMC teams from drug substance process development through delivery of clinical kits. This role oversees both internal and external CMC activities to ensure alignment with program timelines, quality standards, and regulatory requirements. The position will have direct reports and is responsible for mentoring, performance management, and team development. In addition, this individual is partner-facing, serving as a key point of contact for stakeholders and external partners. The role will manage external relationships, including partnerships, and act as the primary contact for contract manufacturing organizations (CMOs) and contract research organizations (CROs) supporting development, analysis, manufacturing, packaging, and labeling activities for Arrowhead drug development programs.

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
• Maintain and expand upon current project tracking tools (ex. Smartsheet, Excel, Power BI)
• 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
• Support vendor management responsibilities and activities, as needed
• Assist in developing and review 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.
• Other duties as assigned

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

Wisconsin pay range

$125,000—$135,000 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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