Plant Operations
Team Lead, Manufacturing Buffer Prep
Office Location: 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 Team Lead, Manufacturing (Buffer Prep) is responsible for overseeing all aspects of buffer preparation operations in support of Arrowhead GMP drug substance manufacturing. This includes the preparation, management, and cleaning of buffer prep equipment, as well as the handling of day tank solvent storage and bulk tank systems. This role ensures compliance with regulatory standards, safety protocols, and internal quality systems while leading and coordinating activities across the buffer prep team. The Team Lead will act as the subject matter expert (SME) for buffer preparation processes and related equipment, driving operational excellence, and supporting manufacturing operations.
Responsibilities
- Lead and oversee all buffer preparation activities to ensure safe, efficient, and compliant operations.
- Manage the setup, preparation, cleaning, and maintenance of buffer prep equipment and associated systems.
- Oversee day tank solvent storage and bulk tank operations, ensuring accuracy and safety in handling and usage.
- Monitor inventory levels of raw materials, solvents, and buffers to ensure uninterrupted production support.
- Ensure compliance with GMP, safety, and environmental regulations in all buffer prep operations.
- Provide training, guidance, and oversight for buffer prep technicians and operators.
- Collaborate with cross-functional teams, including Quality, Engineering, and Manufacturing, to resolve operational issues.
- Maintain accurate documentation of buffer preparation processes, equipment usage, and cleaning activities.
- Support investigations, deviations, CAPAs, and continuous improvement initiatives.
- Serve as the primary point of contact for buffer prep-related audits and inspections.
Requirements:
- BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
- 4 years of experience in GMP manufacturing, in large-scale processing or buffer preparation.
- Prior experience using Process Transfer Systems (PTS) highly preferred.
- Team leadership and management experience a plus.
- Experience supporting audits, deviations, and process improvements in GMP settings.
- Six Sigma or Lean certifications are a plus.
- Able to occasionally lift 50 lbs unassisted
- Able to stand on feet for extended periods of time
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.