Job Description
Job Summary:
- We are looking for a motivated Lab Technical Operations Specialist to join our Manufacturing Science and Technology (MSAT) team. This role is critical for advancing our CAR-T and PSC process development and requires expertise in cell culture and strong data management skills.
Duties and Responsibilities:
The primary focus of this role involves hands-on laboratory work and meticulous data management.
CAR-T Cell Processing:
- Execute the ADA CAR-T process on donor materials, requiring proven experience in laboratory cell culture techniques.
- Support process improvement and characterization studies for allogeneic CAR-T processes.
Pluripotent Stem Cell Processing (PSC):
- Culture, maintain, and differentiate PSCs, specifically hESCs.
- Culture Retinal Pigmented Epithelial (RPE) cells, in both 2D tissue culture flasks and 3D stirred tank bioreactors.
- Support process improvement and characterization studies for PSC and RPE processes.
Documentation and Data Management:
- Thoroughly document experiments in the Benchling electronic laboratory notebook (ELN), adhering strictly to Good Documentation Practices (GDP).
- Perform review and approval of completed experiments within the Benchling ELN.
- Manage in-process and analytical data by accurately transcribing data from various sources into a central data tool.
- Verify data accuracy during transcription and perform process monitoring to identify potential trends.
- Assist with analyzing data and preparation of experimental protocols, reports, and presentations.
Logistics and Coordination:
- Manage process materials and inventory by collaborating with procurement, warehouse, and Vendor Managed Inventory (VMI) personnel.
- Maintain appropriate material stock levels.
- Coordinate the shipping of laboratory samples to various internal and external teams across the network and third-party testing partners.
Requirements:
- HM ok with graduate level experience.
- Must have cell culture experience.
- Experience in laboratory cell culture is required for execution of the CAR-T, PSC, and RPE process.
- Demonstrated proficiency with electronic laboratory notebooks (ELNs), preferably Benchling.
- Strong understanding of Good Documentation Practices (GDP).
- Excellent data entry and data verification skills, with an eye for detail and trend identification.
- Experience or comfort collaborating with cross-functional teams (e.g., procurement, logistics).
- Ability to manage complex logistics, including sample coordination and shipping.