GMP Operations Coordinator

You are detail-oriented, organized, and thrive in bringing structure among chaos. You enjoy both compliance-driven tasks and the challenge of dynamic troubleshooting. You’re hands-on, proactive, and take pride in keeping things stocked, staged, and ready so manufacturing can run smoothly. You proactively address issues, enjoy collaborating cross-functionally, and consistently demonstrate accountability and reliability. You’re comfortable in fast-paced environments and passionate about supporting groundbreaking science.

• Support day-to-day GMP operations including material ordering, receiving, inspection, logging, and distribution of consumables, PPE, and cleaning supplies across the manufacturing facility

• Maintain GMP storage rooms, monitor inventory levels and reorder points, and manage warehouse organization and material segregation to ensure cleanroom supplies are always available

• Prepare for manufacturing runs - scheduling support, pre-run checklists, reagent and consumable staging, and cleanroom setup

• Serve as the second SciOps team member on the manufacturing floor during production runs, supporting operators, troubleshooting logistics in real time, and assisting with environmental monitoring

• Support electronic batch record execution and real-time data entry in MasterControl Mx during manufacturing campaigns

• Execute routine environmental monitoring sampling during and between runs, and document results per established procedures

• Assist with equipment performance qualification documentation, deviation and CAPA investigation logistics, and training record coordination

• Support vendor coordination - assisting the GMP Operations Lead with purchase orders, vendor scheduling, and receipt documentation

• Provide hands-on support to the broader SciOps team, including improvement projects and requests relating to general lab and facilities needs

• Serve as a key on-call responder for facility emergencies and urgent issues (such as power failures, significant leaks, cold storage alarms, etc.) - a rotating team responsibility which includes some nights, weekends, and holidays

• Have 2+ years of experience working in GMP operations, quality assurance, or another highly regulated biotech environment - bonus points if you’ve directly supported cell therapy manufacturing

• Are hands-on and technically adept in cleanroom environments - you know your way around environmental monitoring equipment, understand contamination control practices, and feel at ease maintaining meticulous documentation

• Have practical knowledge of electronic quality management or manufacturing execution systems (MasterControl, Veeva, SAP) and enjoy optimizing how things are tracked, stored, and managed

• Are naturally organized and precise - you take pride in maintaining clear, detailed documentation and have an intuitive feel for regulatory requirements and standards

• Communicate clearly and confidently - whether you’re discussing detailed compliance procedures with the Quality team or providing updates to colleagues in non-technical roles

• Embrace technology and organization - you’re familiar with digital tools such as Google Workspace, Asana, and Notion to track tasks and document work, as well as confident in picking up new systems like MasterControl

• Enjoy diving into complex problems and proactively troubleshooting issues - you’re not one to wait for instructions when you spot a potential improvement or an operational snag

• Are physically comfortable in an active role - you’re able to safely lift and handle materials and supplies (up to 50 lbs), using appropriate support and equipment

• Are flexible and willing to occasionally work outside regular hours to address critical GMP activities, emergencies, or maintenance needs

• Cell therapy or biologics manufacturing

• Inventory and material handling systems (Quartzy, ERP systems, etc.)

• Equipment qualification (IQ/OQ/PQ) support

• Startup or early-stage biotech environments - comfortable with rapid change and scrappy problem-solving

• Environmental monitoring program execution

We take pride in cultivating an environment that fosters collaboration, open communication, and authenticity. We believe that great results are best delivered by a highly creative team working in concert. We are an equal opportunity employer; we do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are diverse in background and singular in mission.