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. Youre 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. Youre 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 youve 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 youre discussing detailed compliance procedures with the Quality team or providing updates to colleagues in non-technical roles

• Embrace technology and organization - youre 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 - youre not one to wait for instructions when you spot a potential improvement or an operational snag

• Are physically comfortable in an active role - youre 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