Manager, Product Development & Operations in Verona

Energy Jobline ZR; Verona; In loco; EUR 86.000 - 100.000; Tempo pieno

Descrizione del lavoro

A pharmaceutical company based in Italy is seeking a Manager of Product Development & Operations. This key role entails overseeing CMC project teams, managing operations from development to delivery, and ensuring compliance with GLP and GMP regulations. Candidates should have a degree in a scientific discipline and relevant experience in the pharmaceutical industry. Competitive salaries and a strong benefits package are offered.

Servizi

Competitive salaries

Excellent benefit package

Competenze

• Minimum 3 years of experience in a pharmaceutical company, CMO, or CRO.
• Knowledge of GLP, GMP, GDP regulations.
• Ability to handle competing priorities in a fast-paced environment.

Mansioni

• Oversee global operational activities including development and manufacturing.
• Communicate project status to management and stakeholders.
• Track and review vendor invoices and manage contract negotiations.

Conoscenze

MS Office skills

Excellent communication skills

Detail oriented

Project management

Formazione

Bachelor's degree in a scientific discipline

Master's degree in a scientific discipline

Strumenti

Smart Sheet

Microsoft Dynamics (D365)

SAP

Descrizione del lavoro

The Position

The Manager, Product Development & Operations is accountable for the project and is responsible for the indirect management of CMC project teams from process development to delivery of finished goods to depots or 3PLs. They will manage both internal and external CMC activities, act as the primary contact for outsourced contract manufacturing organizations (CMO) and contract research organizations (CRO) involved with Arrowhead drug development programs, facilitate team collaboration to identify risks and opportunities, work with Arrowhead leadership to prioritize work, and manage vendor onboarding, contracts, project budgets, timelines, KPIs and deliverables. This non-laboratory position requires cross-functional collaboration with technical, legal, finance, clinical, commercial, logistics, supply chain, quality, and regulatory functions.

Responsibilities

• Oversee global operational activities: development, manufacturing, warehousing, distribution, supply chain, logistics
• Act as primary point of contact for projects, facilitating communication between internal and external team members for CMC development, analytical, manufacturing, packaging, labeling, and distribution activities
• Partner with the cross-functional project team (chemistry, analytical, quality, regulatory, supply chain, clinical operations, commercial, marketing) to deliver quality product on time
• Communicate project status and vendor activities to Arrowhead management and stakeholders
• Monitor internal and external inventory of intermediates, API, investigational product, retains, samples, and clinical supplies
• Manage budget, timeline, quality and deliverables for each project and vendor
• Develop and implement global process standards, best practices
• Develop and maintain and report KPIs for projects and external partners
• Generate and maintain project tracking tools using Smartsheet, Excel, Power Bi and other databases
• Work with technical, legal and finance groups to draft RFPs, track, manage and negotiate new contracts, supply agreements, confidentiality agreements, purchase orders, etc. for new and existing vendors
• Track and review vendor invoices; collaborate with finance department to process payments
• Lead project meetings, vendor visits and conference calls
• Oversee shipments and storage of GLP, GMP, and clinical materials in accordance with Arrowhead SOPs and GDP
• Collaborate with clinical supply and supply chain to ensure materials are ready for current and upcoming developmental programs

Requirements

• Bachelor's degree in a scientific discipline (e.g., Chemistry, Chemical Engineering, Biochemistry, or Biotechnology) and a minimum of 3 years of experience in a pharmaceutical company, CMO, or CRO; or
• Master's degree in a scientific discipline (e.g., Chemistry, Chemical Engineering, Biochemistry, or Biotechnology) and at least 1 year of relevant experience in a pharmaceutical company, CMO, or CRO.
• 0-2 years in a project management or project coordination role
• Knowledge of applicable GLP, GMP, GDP and regulatory guidance for pharmaceutical manufacturing and testing
• Strong MS Office skills (Outlook, Excel, PowerPoint, and Word)
• Excellent verbal and written communication skills
• A detail oriented, organized, self-starter who endeavors to anticipate problems and seeks opportunities to grow the role and responsibilities at Arrowhead
• Ability to work prolonged periods at a desk and working on a computer.
• Aptitude for independently resolving competing priorities in a fast-paced environment
• Willingness and ability to travel on a limited basis (<25% of time) domestically and internationally to partner and vendor locations

Preferred Experience

• Previous experience in pharmaceutical manufacturing, operations, clinical supply, or project management roles
• Experience with Project Management Software such as Smart Sheet or MS Project
• Experience with an ERP system such as Microsoft Dynamics (D365) or SAP
• GLP or GMP Laboratory or Manufacturing experience

Wisconsin pay range $100,000—$115,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.