Director, Lab Services

About the team:

The facilities lab services team consisting of approximately 12 employees and contractors, supports all operational aspects of our Quality and R&D laboratories including instrumentation support, lab consumable inventory management, and shipping and receiving for our Cambridge facility. Our Cambridge facility hosts Quality lab suites inspected and approved by the FDA to support our commercial Oncology product, making a strong background and experience with GXP necessary for this position.

How you’ll spend your time:

• Responsible for the oversight of the 2seventy lab sub-function, including the planning, implementing, and oversight of team operations, successful assignment delivery, and employee performance.
• Lead a team of skilled instrument technicians, engineers, and 3rd party contractors/consultants to oversee and/or execute the routine and emergency maintenance and repairs to laboratory equipment, manage inventory levels for lab consumables, and deliver our shipping and receiving operations.
• Establish maintenance procedures and/or services required to ensure maximum system reliability for all laboratory instrumentation. Track metrics associated with lab equipment maintenance, calibrations, and on-demand services to ensure service targets are reliably met.
• Ensure emergency response procedures and training are sufficient to minimize downtime.
• Oversee and/or execute operational responsibility for lab consumable inventory management to ensure the continuous operations of our R&D and Quality labs.
• Responsible for the oversight of vendor management program including planning and scheduling for laboratory equipment repair and maintenance according to prioritizations set by the research and development stakeholders.
• Responsible for the oversight of all general Receiving and Shipping operations in Cambridge facility including cGMP Warehouse.
• Partner with Facilities leadership team on periodic service contract reviews for critical laboratory equipment and instrumentation.
• Collaborate with Facilities leadership team and Finance business partner on annual budget management activities.
• Maintain all records and documentation for laboratory equipment with a Computerized Maintenance Management System (CMMS), laboratory consumables inventory management, and shipping & receiving to leverage this information for continuous process improvement and metric management. Maintain documentation according to Good Documentation practices and SOPs.
• Implement/maintain a qualification/validation program for both systems and operational processes to allow for their use in GLP/cGMP processes.
• Mentor junior staff to ensure technical and operational excellence within the lab services team.
  

Who you are and what you’ve accomplished:

• Bachelor’s degree in electronics, instrumentation, or science-related field with 15+ years of experience in the installation, troubleshooting, repair, and commissioning/decommissioning of analytical equipment and/or lab consumables inventory management in a cGMP environment.
• Servicing experience with various technique groups such as HPLC, Automation, PCR, Bioreactors, and basic lab equipment types.
• Procedural responsibility and operational oversight for lab consumables inventory management and shipping and receiving.
• Strong familiarity with cGMPs and the pharmaceutical industry required.
• Strong people management and customer service skills required.
• Attention to detail, demand for high-quality work, and sense of passion and urgency to achieve goals and improve the lives of patients
• Looking to solve difficult, messy problems like developing cell therapies for cancer—it’s hard!
• Ability to communicate above and below level in a way that fosters relationship building, including cross-functional teams, and external relationships with vendors
• Successfully worked in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
• Excellent attention to detail, project and time management skills, and the ability to manage multiple priorities
• Embraces and models our core values—re-think, have heart, better 2gether, time is now