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 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:

• Act as the point person for GMP-related lab operations requests, material handling needs, troubleshooting, inventory management, and oversee stocking, ordering, shipping, and receiving activities
• Perform routine cleanroom maintenance, coordinate vendor services, and handle operational tasks
• Conduct environmental monitoring (temperature, humidity, particle counts, etc.) surveys and ensure the facility is within standards during operation
• Collaborate with the R&D and Process Development teams to ensure smooth operational tech transfers to GMP
• Interface proactively with the Quality team, ensuring compliance with regulatory requirements and internal SOPs
• Support documentation, validation, and calibration efforts for GMP instrumentation and facility equipment, including IQ/OQ/PQ activities under the guidance and final approval of the Quality team
• Provide hands-on support to the broader Sci Ops 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:

• Have 2+ years of experience working in GMP operations, lab management, quality assurance, or another highly regulated biotech environment – bonus points if you’ve directly supported clinical manufacturing or equipment validation.
• Are hands-on and technically adept in cleanroom environments – you know your way around environmental monitoring equipment, understand contamination control practices deeply, and feel at ease maintaining meticulous documentation
• Have practical knowledge of instrument calibration, equipment qualification processes (IQ/OQ/PQ), and vendor management – you’re comfortable coordinating with external partners and internal teams to ensure smooth operations
• Are naturally organized and precise – you take pride in maintaining clear, detailed documentation and have an intuitive feel for regulatory requirements and standards
• Know inventory and material handling systems well (Quartzy, ERP systems, etc.) and enjoy optimizing how things are tracked, stored, and managed
• 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 softwares or systems to monitor the facilities
• 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

$75,000 – $95,000 a year

Total compensation also includes generous equity and benefits including:

– Medical, dental, and vision insurance for you and your family
– 401(k) plan with 4% matching
– Flexible time off and 10 company holidays per year
– Annual learning & development stipend
– Daily Retro-sponsored lunch and snacks