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
As an Associate Engineer I, Process Engineering, you will play a critical role in our process engineering operations and contribute to continuous improvements to enhance efficiency, safety, and productivity. You will be responsible for promoting the smooth and efficient operation of our manufacturing processes. Core duties will include overseeing implementation of process/safety improvements, providing support to the processing team, and equipment management.
Responsibilities
- Process Improvements
- Collaborate with cross-functional teams to translate experimental findings into actionable process improvements.
- Perform experiments in collaboration with your team to optimize existing processes or develop new ones.
- Participate in process risk assessments and recommend mitigation strategies.
- New Process Integration
- Support process transfer from Process Development.
- Support process scale-up and commercialization.
- Process Safety
- Participate in process safety evaluations, such as PSSR and PHA, for new processes, new equipment, modifications to processes, modifications to equipment and as seen fit.
- Collaborate with manufacturing and safety teams to identify safety improvements.
- Maintain safety systems to ensure the process remains in a ready state and future safety issues can be prevented.
- Demonstrate and support a culture of safety awareness and compliance within the production team.
- Process Support
- Provide technical support for production operations, identify and assist resolution of manufacturing issues.
- Process Equipment Management
- Support manufacturing staff in the safe and effective use of new equipment.
- Support equipment and process qualification activities and ensure compliance with regulatory requirements.
- Assist with troubleshooting and repair of equipment internally when feasible.
- Process Monitoring and Troubleshooting
- Troubleshoot process and equipment issues on the floor with manufacturing staff. Escalate to Maintenance as necessary.
- Participate in routine process monitoring.
- Support WI, SOP, and document updates for manufacturing equipment and systems.
- Documentation Management
- Review and update P&IDs for production processes, including equipment, instrumentation, and piping systems.
- Follow P&ID change management processes, including version control and documentation updates.
- Reference the design and validation documentation for equipment to ensure compliance and design intent are maintained.
- Additional Duties as required:
- Help develop batch records in a GMP environment.
- Occasionally assist with production work as needed
Requirements
- Bachelor's degree in Chemical Engineering, or a related field
- 0-2 years of experience in process engineering or a similar role within a manufacturing environment.
- Proficient in data analysis tools and software.
- Excellent problem-solving skills and the ability to apply analytical thinking to identify and resolve process-related issues.
- Strong communication and interpersonal skills, with the ability to collaborate effectively across cross-functional teams.
- Good verbal and written communication skills.
- Excellent technical writing skills with high attention to detail.
- Able to occasionally lift 50 lbs unassisted.
- Able to work for extended periods of time in a chemical fume hood.
- Able to stand on feet for extended periods of time.
Preferred
- Experience through research or internship/co-op
- Experience working in a GMP setting with controlled documentation.
- Knowledge of safety regulations, process optimization methodologies, and experimental design.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
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Top Skills
What We Do
Arrowhead Pharmaceuticals is a clinical stage, Nasdaq listed (ticker ARWR) company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, our 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. Our RNAi-based therapeutics are at the leading edge of genetic-based therapy with the potential to bring life changing treatments for patients.
Our Targeted RNAi Molecule (TRiMTM) platform utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting while being structurally simple. The TRiM platform builds on more than a decade of work on actively targeted drug delivery and offers several advantages including simplified manufacturing and reduced costs; multiple routes of administration; and potential for improved safety.
Our employees are nimble, science-driven, and innovative professionals. A career at Arrowhead offers the opportunity to collaborate with top notch scientists to rapidly discover and develop RNAi-based therapeutics to add to our growing pipeline.
Research and development activities are located in Madison, WI. Our R&D group includes fully-integrated capabilities for chemistry, biology, and toxicology. Madison is an exciting and sophisticated city that includes state government, the flagship campus of the University of Wisconsin, and major research organizations.
Our HQ, clinical and regulatory operations are located in Pasadena, CA. Just north of Los Angeles and resting in the foothills of the San Gabriel Mountains, Pasadena is known for its natural scenic beauty, vibrant cultural and academic environment and rich architectural setting.
