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Arrowhead Pharmaceuticals · 2 weeks ago

Manager, Product Development & Operations

Verona, WI

Full-time

Onsite

Entry, Mid Level

$100K/yr - $115K/yr

1+ years exp

Arrowhead Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative drugs for diseases with a genetic basis. The Manager, Product Development & Operations is responsible for overseeing project management and collaboration with internal and external teams to ensure the successful delivery of drug development programs.

BiotechnologyHealth CareNanotechnologyPharmaceutical

Comp. & Benefits

No H1B

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, and 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 venders

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 up-coming developmental programs

Qualification

Pharmaceutical ManufacturingRegulatory GuidanceProject ManagementGLPGMP KnowledgeMS Office SkillsVendor ManagementERP System ExperienceProject Tracking ToolsCommunicationDetail OrientedSelf-StarterProblem SolvingTime ManagementTeam Collaboration

Required

Bachelor's degree in a scientific discipline (e.g., Chemistry, Chemical Engineering, Biochemistry, or Biotechnology) 3 years of experience in a pharmaceutical company, contract manufacturing organization (CMO), or contract research organization (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