GMP Operations Coordinator

About you:

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.

What you’ll do in this role:

• 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

You might thrive in this role if you:

• 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

Bonus if you have experience with:

• 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