Associate Director, Packaging Engineering

Arrowhead Pharmaceuticals•San Diego, CA

40d•$170,000 - $200,000

About The Position

Associate Director, Packaging Engineering Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 Associate Director, Packaging Engineering is responsible for the technical aspects of commercial packaging for drug substance, drug product, primary container/closure, and final product presentations including secondary/tertiary packaging/configuration for shipment. This position will lead the design and development of packaging for commercialization of new products through the design transfer process, as well as manage changes to existing products. This role will work closely with Global Operations, Development, Quality, Procurement, Regulatory, Device Engineering, and outside vendors.

Requirements

Bachelor's Degree in Engineering or other field related to the essential duties of this role and 10+ years of increasing responsibility in pharmaceutical industry, focused on packaging processes and procedures. (or a Master's Degree with 8+ years of experience, or a Doctorate Degree with 5+ years of experience.)
Strong problem solving, risk assessment, and risk management skills and capable of working on multiple projects in a deadline driven environment.
Exhibits excellent interpersonal communication, project management, collaboration, and analytical skills.
Strong MS Excel, PowerPoint, and Word skills.
Experience using Smartsheet or other work management software.
Exhibits creativity in adapting to changing situations, development of contingency plans and comfortable with making decisions.

Nice To Haves

Expertise in testing, validation, packaging laws, industry-recognized standards and test methods (e.g., ASTM, ISTA, ISO, USP), regulations (e.g., ISO 11607, 21 CFR 820), and risk management to identify and recommend design improvements that address deficiencies.
Experience developing and commercializing new products on cross-functional teams.
Experience with cold chain products.

Responsibilities

Create and implement long-term packaging development strategy.
Create and execute project plans and schedules.
Lead and execute packaging strategies on projects, working with internal and external stakeholders to develop packaging designs, materials, and processes for new products.
Create and maintain packaging design and packaging validation programs compliant with packaging laws, industry-recognized standards, and test methods.
Develop, execute, and manage documents for packaging specifications, development plans, testing protocols, qualification/validation plans, risk management, and other related packaging development documents.
Initiate/review change controls, deviations, CAPAs, and risk assessments related to packaging components/configuration within QMS in collaboration with Quality. Support root cause analysis activities.
Drive continuous improvement in the packaging processes from project initiation through launch as well as life cycle management in alignment with regulatory and commercial manufacturing requirements.
Provide technical support for commercial packaging vendor sourcing activities.
Sponsor and/or lead projects, initiatives, and process improvements falling under packaging engineering business systems scope to build for the future.
All other duties as assigned.