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
This position works closely with Quality Assurance, Laboratory, and Manufacturing staff to complete and oversee Arrowhead’s maintenance and calibrations for controlled Equipment. This position will follow safety This position will maintain asset records and document the completion of work in Arrowhead’s regulated asset management system. This position may be required to write minor equipment change controls and initiate deviations in Arrowhead’s quality management system.
Responsibilities
- Independently perform calibration to NIST standards and maintenance on manufacturing, analytical, and process control systems, including, but not limited to:
- Synthesis and Purification systems
- Lyophilization equipment
- Balances, Pipettes, and benchtop laboratory equipment
- Analytical laboratory equipment
- Temperature, pressure, and flow instruments
- Fridge/Freezer maintenance and mapping
- Chemical formulation and distribution systems
- Process utility and waste collection systems
- Manage monthly assignments to reliably complete routine and non-routine maintenance and calibration tasks on time. Resolves complex roadblocks independently.
- Have knowledge and ability to perform a diverse set of routine maintenance and calibration tasks, including multi-step techniques of moderate complexity.
- Perform non-routine maintenance with a degree of independence. Recognize unusual circumstances and begins to identify root causes. Collaborate with manager and subject matter experts on problem solving and approaches to complex problems.
- Monitor process utility performance, including regular monitoring and testing to ensure reliable performance.
- Interface with regulated asset management system to track equipment statuses, document accurate work records, update asset records, and create calibration certificates following good documentation practices.
- Support vendors who are on-site performing services, including oversight of work documentation.
- Execute or oversee vendor completion of well-defined equipment and analytical instrument qualification protocols for complex systems.
- Proficient in safety programs. Independently follows safe work procedures and identifies permits needed for non-routine situations. Collaborate with cross-functional teams to complete a hazards assessment. Completes permits for approval.
- Begins to train junior teammates in calibration, maintenance, or safety practices.
- Begins to recommend new approaches or techniques to current and new practices. Makes recommendations and supports teams with continuous improvements.
- Wear all appropriate PPE for the workspace including but not limited to: safety glasses, steel toe shoes, hard hat, vest, clean space gowning, Cryo gloves, electrical safety gloves, fall protection.
Requirements:
- Associate’s Degree in mechanics, electronics technology or similar field, and 8 years of experience in a laboratory/manufacturing calibration role. (Equivalent High School and work experience will be considered)
- At least 4 years of work experience servicing complex laboratory/manufacturing equipment
- Must be proficient with reading and understanding engineering drawings
- Knowledgeable and experienced with LOTO (lock out tag out)
- Experience with controlled documentation (SOP/WI)
- 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
- Follow written procedures and work instructions with attention to detail
- Adhere to manufacturing and laboratory safety policies and procedures
- Good collaboration skills with ability to work with department team members.
Preferred:
- Calibration experience with conductivity, pressure, flow, level indicators, temperature, mass, time, balances, cromotography, rotational and general lab equipment
- Experience working on and trobleshoting automated systems.
- Experience following change control practices for equipment and computer systems.
- Experience working with Blue Mountain Regulatory Asset Management System
- Experience with safe work permits including hot work, line breaks, and working in electrically classified areas.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.