Quick overview
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
Primarily responsible for overseeing the maintenance and requisite qualification for analytical and manufacturing equipment. Also responsible for maintaining and developing new processes in support of calibration, maintenance, and troubleshooting equipment.
This role is full-time onsite, 5 days a week in Verona, WI.
Responsibilities
- Oversee vendor and internal calibration, maintenance, and repair activities, providing support and expertise as needed
- Support regulatory audits supplying technical expertise
- Perform Blue Mountain Ram Lead reviews on vendor and internally performed service
- Maintain and develop in-house processes related to the calibration and service of equipment
- Review and support equipment data trending to supply process improvement and drive better service
- Lead and support projects related to improving new or existing development
- Lead activities related to EMS
- Identify improvement process to increase efficiency and reduce equipment downtime
- Create and support equipment change control documentation
Requirements
- Bachelor’s degree in a related field and 11 years of relative experience, equivalent job experience accepted
- Must be proficient with reading and understanding engineering drawings
- 5+ years of experience servicing or overseeing complex laboratory/manufacturing equipment
- Knowledge of LOTO (lock out tag out)
- Electrical and mechanical troubleshooting experience
- 5+ years of experience working in a GMP setting
- Experience creating controlled documentation (SOP/WI)
- Experience implementing change control practices for equipment and computer systems.
- Proficient in Microsoft Office Word, Excel, PowerPoint, and similar software
- Excellent technical writing skills with high attention to detail
- Good verbal and written communication skills
- Adhere to laboratory safety policies and procedures
- Good collaboration skills with ability to work across departments
Preferred
- Pharmaceutical or Biotech equipment experience
- Experience working with Blue Mountain Regulatory Asset Management System or equivalent
- Project management experience
- Leadership experience
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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