Responsibilities Include
- Set up and maintain operations of the CMC labs, including management of day-to-day activities and coordinating meetings with internal and external partners.
- Participate and coordinate involvement in daily lab tasks, including scheduling equipment maintenance.
- Oversee operation and maintenance of essential equipment, and monitor CMC service records and contracts.
- Onboard new CMC scientists including lab safety training, building tours, and equipment usage training.
- Coordinates shipping and receiving CMC materials with external vendors.
- Manage inventory supply for CMC lab spaces, working in conjunction with the Research Lab Manager for shared resources, and act as primary resource for purchasing laboratory resources for CMC related activities.
- Manage CMC consumable inventory and organize stock rooms.
- Assist in optimizing existing lab space to better improve workflows and space usage.
- Develop, implement, and maintain laboratory guidelines and standard operating procedures consistent with GXP requirements.
- With support from Cabaletta Compliance and Quality teams, ensure compliance with local, state, and federal safety regulations; participate in training personnel on compliance in lab safety, conduct, and standards.
- Facilitate internal and external audits, including being liaison between lab personnel and visiting individuals.
- Manage room maintenance and cleanliness and ensure lab spaces are organized and functional.
- Act as point person between lab personnel and Core Lab Activities.
- Must be able to lead CMC projects independently and work collaboratively with Research Lab Manager to ensure cohesive environment.