Chemistry Manufacturing & Controls
Associate Director, Device Engineering
Office Location: San Diego, CA or Verona, WI
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, Device Engineering is a detail-oriented and results-driven individual with a strong understanding of product design, pharmaceutical device regulations, GMP standards and workload management. This individual is responsible for driving commercial readiness and managing the life cycle of drug device combination products. This role will work closely with Global Operations, Development, Quality, Procurement, Regulatory, Packaging Engineering, consultants and outside vendors.
Responsibilities
- Develop and oversee design control system and business strategies to support commercial device/combination drug development.
- Create and execute project plans and schedules.
- Develop, execute, and manage documents for product design, specifications, development plans, characterization plans, verification/validation plans, risk management, human factors and other related product development documents.
- Author or Review/Approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
- Participate in design reviews, provide critical design for manufacturing input to ensure product designs are robust for manufacturing.
- Support site and vendor risk assessments, develop and maintain pFMEAs, and develop control plans to mitigate risks. Ensure that all product functional requirements are translated into manufacturing requirements and process controls.
- Provide technical support for CMO/vendor sourcing activities.
- Sponsor and/or lead projects, initiatives, and process improvements falling under device engineering business systems scope to build for the future.
Requirements
- Bachelor’s Degree in Engineering or other field related to the essential duties of this role and 10+ years of increasing responsibility in medical device industry, focused on engineering processes and procedures. (or a Master’s Degree with 8+ years of experience, or a Doctorate Degree with 5+ years of experience.)
- 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
Preferred:
- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
- Experience with product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
- Deep experience and knowledge in medical device development and commercialization, process validation, and related global regulatory requirements.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.