Duration
- 6 months to start (plus additional extensions)
Job Description
- Our client is currently seeking a Lab Operations Manager with a proven background of managing lab operations for large molecule products such as viral vectors, proteins, cell & gene therapy. Our client has several labs that require support to ensure compliance, safety, efficiency, and budget oversight. The initial scope will require a couple of weeks of company-required onboarding processes, meetings with Vendors, Scientists, Equipment Management Teams, Quality Group, Maintenance/Lab Construction groups and other relevant departments as required. The initial project scope will require the consultant to assess the labs in person. There will be some project management (PM) activities pertaining to purchase orders, budget management, weekly meetings with team members as well as compliance partners, communicating with all levels of personnel and cutting out financial costs.
- The labs are in an R&D environment with large molecule drug production taking place. There will be formulation and process equipment in the facilities such as pH meters, centrifuges, lab scales, balances, UPLC/HPLC, mass spectrometry, pipettes, introns, mixers for viral vector formulations and other related lab equipment. There will be weekly meetings and extensive efforts working directly with personnel in the lab such as scientists to ensure the lab is running properly with compliant equipment, CBER/CDER regulations, BSL knowledge and cGLP requirements.
- Must carry 8+ years of proven experience with oversight of labs, collaborating & communication with all levels of personnel (mostly scientists), project management activities and equipment listed above. Cell/gene therapy, viral vectors, proteins or large molecule drug product labs is also required.
PA: Lab Operations Consultant (235121)
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