Senior Manager, Metrology and Process Equipment en Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals · Verona, Estados Unidos De América · Onsite
- Senior
- Oficina en Verona
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 Senior Manager, Metrology and Process Equipment is responsible for coordinating and executing manufacturing equipment and analytical instrument lifecyle management strategies. They will oversee the maintenance, repair, calibration, and safe operation of all equipment used in GMP and GLP activities. This position will be responsible for ensuring that equipment is maintained and meets applicable regulatory requirements to support ongoing operations in a fast-paced drug substance manufacturing facility and regulated development laboratories. This position leads the Metrology team by establishing clear direction and setting priority for operational and strategic project execution. This position will be the central point of coordination and communication for cross-functional departments supported by the Metrology team and will be responsible for establishing effective team communication practices with internal customers.
Responsibilities
- Develop and oversee execution of strategic plans to grow the equipment maintenance and calibration program at Arrowhead to support new systems and internalize contracted work.
- Work cross functionally to provide oversight of the transfer of maintenance and calibration responsibility to the maintenance unit from technical experts in Engineering, including establishing maintenance procedures, training plans, spare parts inventories, and service contracts.
- Partner with quality, internal customers, and supporting departments to improve and optimize maintenance and calibration workflows by developing strategic plans for continuous improvements and oversee plan execution.
- Provide guidance in the investigation and resolution of calibration and maintenance issues by technical team members within and outside the reporting structure.
- Develop and report on performance metrics for the Metrology team focusing on service effectiveness and equipment performance. Lead projects to identify and implement improvements.
- Provide managerial leadership for the Metrology team including individual development plans, goal setting, performance evaluations, recruitment and retention, and ongoing guidance and feedback for team leaders and technical experts.
- Organize assignments and resources across the Metrology team to ensure preventative and corrective maintenance is completed on schedule to support business priorities and according to quality and procedural requirements.
- Effectively communicate with cross functional leaders and individual contributors to achieve team and business objectives
- Establish team expectations and policy for communication practices with internal customers and models best practices.
- Responsible for ensuring that the Metrology team has the tools, expertise, and training needed to safely and successfully complete assigned work.
- Partner with Environmental Health & Safety to identify support needs and lead implementation of safe work policies and practices within the Metrology team.
- Ensure safety practices and policies are adhered to across the Metrology team and by service vendors.
- Represent the maintenance function for change review, approval, and implementation. Lead change adoption by impacted Metrology team members.
- Represent business ownership of Arrowhead’s regulatory asset management system. Develop a strategic plan for ongoing system issues and enhancements and partner with system administrators in IS&I for implementation.
- Responsible for the quality and consistency of service records, asset management system data, and equipment files.
- Develop the annual maintenance budget for the Metrology team and tracks department spend against approved budget throughout the year.
- Provide oversight and organization for maintenance service contract renewals with support from the Purchasing.
Requirements:
- BS degree in engineering / related technical field or equivalent work experience.
- At least 10+ years of maintenance or metrology experience preferably within pharmaceutical or similarly regulated environment; at least of which 5 years were in a maintenance leadership role within a pharmaceutical or similarly regulated environment.
- Advanced knowledge of mechanical and electrical systems.
- Knowledge of maintenance requirements for manufacturing process equipment such as purified water, clean in place, buffer formulation, and reagent distribution systems.
- Prior experience with safe work practices such as lockout tagout, hot work permits, and line break procedures.
- Experience selecting and managing external service vendors.
- Proficiency with Computerized Maintenance Management Systems, including best practices for asset identification and hierarchies.
Preferred:
- Knowledgeable on best practices for calibration common instruments used for pressure, temperature, flow, and weight measurement in a regulated environment.
- Experience with safe work practices for electrically classified areas
- Knowledge of analytical instrument maintenance and calibration practices, including HPLCs.
- Prior experience with Blue Mountain Regulatory Asset Manager
- Prior experience with change controls for equipment and instrument systems in regulated and/or hazardous environments.
- Prior experience with maintenance on automated process equipment.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
