Plant Operations
Metrology, Team Leader
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 and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Team Leader is responsible for leading collaboration between Metrology Technicians, Quality Assurance teams, and laboratory staff to manage completion of Arrowhead’s PMs, calibrations, and qualifications for controlled Equipment.
This position will also be required to assist with drafting, reviewing, executing, and completion of qualification protocols, in addition to creating SOP and Work Instructions.
The Team Leader will supervise a team of Metrology Technicians and be the first point of contact and escalation for troubleshooting, deliverable timelines, and laboratory needs. The Team Leader will develop and lead a cohesive team working towards common goals.
Responsibilities
- Operational Duties:
- Monitor equipment – including regular testing and maintenance tasks
- Manage and perform the internal PM/calibration schedule for equipment, including, but not limited to:
- Synthesis
- Chromatography
- HPLC
- GC
- LCMS
- TFF and Lyophilization
- Balances and Pipettes
- Temperature, pressure, and flow
- Recirculating Chillers / Temperature Control Units
- Fridge/Freezer temperature mapping
- Fridge/Freezer probe management
- USP water distribution/generation skids
- Buffer formulation and distribution
- Chemical distribution, waste collection, and process utility systems
- Manage and coordinate any external PM/calibration, including, but not limited to:
- Coordinating external vendors to come onsite to perform PMs
- Coordinating shipping of items for calibration services
- Actively look for optimization opportunities
- Perform, track, and maintain vendor training records
- Troubleshoot and manage unplanned repairs to assigned equipment
- Generate and manage a spare parts inventory
- Coordinate and execute where applicable, all IQ/OQ/PQ activities, including drafting of Equipment Qualification Reports (EQRs)
- Interface with regulated asset management system to track equipment statuses, document work records, and update asset records.
- 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.
- Managerial Duties
- Mentor and coach team members, promoting a culture of continuous learning and improvement.
- Facilitate effective communication and collaboration amongst team members and across departments.
- Serve as a liaison and first point of contact between staff and management to address operational issues an implement solutions.
- Assist in development and implementation of training programs for new and existing team members.
- Identify opportunities for process improvements within the team’s workflow, and collaborate to implement them.
Requirements:
- Bachelor’s degree in related field- additional experience conditionally accepted in leu of degree
- Experience mentoring or leading team members
- Must be proficient with reading and understanding engineering drawings
- Knowledgeable and experienced with LOTO (lock out tag out)
- Experience with controlled documentation (SOP/WI)
- Experience following 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
- Follow written procedures and work instructions with attention to detail
- Adhere to laboratory safety policies and procedures
- Good collaboration skills with ability to work across departments
Preferred:
- Prior experience managing direct reports
- Experience with replacement or repair of diaphragm pumps and process valves
- Calibration experience with conductivity, pressure, flow, level indicators, temperature, mass, time, balances, chromatography, rotational and general lab equipment
- Experience working on and troubleshooting electrical & mechanical equipment and automated 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.
- 3-5 years of GMP lab experience
- 4+ years of experience servicing complex laboratory/manufacturing equipment or automated systems
- Electrical and mechanical troubleshooting minimum 2-3 years of experience
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.