<p>The Position</p> <p>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.</p> <p>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.</p> <p>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.</p> <p>Responsibilities</p> <ul> <li> <p>Operational Duties:</p> </li><li> <p>Monitor equipment - including regular testing and maintenance tasks</p> </li><li> <p>Manage and perform the internal PM/calibration schedule for equipment, including, but not limited to:</p> </li><li> <p>Synthesis</p> </li><li> <p>Chromatography</p> </li><li> <p>HPLC</p> </li><li> <p>GC</p> </li><li> <p>LCMS</p> </li><li> <p>TFF and Lyophilization</p> </li><li> <p>Balances and Pipettes</p> </li><li> <p>Temperature, pressure, and flow</p> </li><li> <p>Recirculating Chillers / Temperature Control Units</p> </li><li> <p>Fridge/Freezer temperature mapping</p> </li><li> <p>Fridge/Freezer probe management</p> </li><li> <p>USP water distribution/generation skids</p> </li><li> <p>Buffer formulation and distribution</p> </li><li> <p>Chemical distribution, waste collection, and process utility systems</p> </li><li> <p>Manage and coordinate any external PM/calibration, including, but not limited to:</p> </li><li> <p>Coordinating external vendors to come onsite to perform PMs</p> </li><li> <p>Coordinating shipping of items for calibration services</p> </li><li> <p>Actively look for optimization opportunities</p> </li><li> <p>Perform, track, and maintain vendor training records</p> </li><li> <p>Troubleshoot and manage unplanned repairs to assigned equipment</p> </li><li> <p>Generate and manage a spare parts inventory</p> </li><li> <p>Coordinate and execute where applicable, all IQ/OQ/PQ activities, including drafting of Equipment Qualification Reports (EQRs)</p> </li><li> <p>Interface with regulated asset management system to track equipment statuses, document work records, and update asset records.</p> </li><li> <p>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.</p> </li><li> <p>Managerial Duties</p> </li><li> <p>Mentor and coach team members, promoting a culture of continuous learning and improvement.</p> </li><li> <p>Facilitate effective communication and collaboration amongst team members and across departments.</p> </li><li> <p>Serve as a liaison and first point of contact between staff and management to address operational issues an implement solutions.</p> </li><li> <p>Assist in development and implementation of training programs for new and existing team members.</p> </li><li> <p>Identify opportunities for process improvements within the team's workflow, and collaborate to implement them.</p> </li></ul> <p>Requirements:</p> <ul> <li>Bachelor's degree in related field- additional experience conditionally accepted in leu of degree </li><li>Experience mentoring or leading team members </li><li>Must be proficient with reading and understanding engineering drawings </li><li>Knowledgeable and experienced with LOTO (lock out tag out) </li><li>Experience with controlled documentation (SOP/WI) </li><li>Experience following change control practices for equipment and computer systems. </li><li>Proficient in Microsoft Office Word, Excel, PowerPoint, and similar software </li><li>Excellent technical writing skills with high attention to detail </li><li>Good verbal and written communication skills </li><li>Follow written procedures and work instructions with attention to detail </li><li>Adhere to laboratory safety policies and procedures </li><li>Good collaboration skills with ability to work across departments </li></ul> <p>Preferred:</p> <ul> <li>Prior experience managing direct reports </li><li>Experience with replacement or repair of diaphragm pumps and process valves </li><li>Calibration experience with conductivity, pressure, flow, level indicators, temperature, mass, time, balances, chromatography, rotational and general lab equipment </li><li>Experience working on and troubleshooting electrical & mechanical equipment and automated systems. </li><li>Experience working with Blue Mountain Regulatory Asset Management System </li><li>Experience with safe work permits including hot work, line breaks, and working in electrically classified areas. </li><li>3-5 years of GMP lab experience </li><li>4+ years of experience servicing complex laboratory/manufacturing equipment or automated systems </li><li>Electrical and mechanical troubleshooting minimum 2-3 years of experience </li></ul>