Laboratory Manager Cell & Gene Therapy (m/f/d)

• Manage and supervise the Associate/Laboratory Scientists in the execution of:
• Molecular analyses according to defined standard operating procedures and protocols under development, including techniques such as nucleic acid isolation, (RT)qPCR, or standard and customized library preparation protocols for DNA/RNA sequencing on different platforms;
• Experiments for assay development, optimization, qualification/validation and implementation within the routine testing laboratory;
• Implementation of new lab devices, the preventive maintenance and verification of existing lab equipment, and the preparation of related documentation (CSV, IQ/OQ, DQ, PQ, etc.);
• Maintenance of written/electronic records of laboratory work and results according to existing quality management standards and good documentation practices;
• Determine project needs in collaboration with the Scientific team members or corresponding supervisor and, accordingly, complete operational requirements by scheduling and assigning employees;
• Determine and define quality standards to maintain laboratory equipment performance in collaboration with the Quality Management and Scientific teams;
• Collaborate and coordinate with the Quality Management, IT and Scientific teams for the design, planning and establishment of processes and related documentation associated with the implementation of new techniques or devices within a GLP/GCP compliant environment;
• Support the Quality Management team with GxP audits;
• Contribute to the maintenance of the laboratory staff by assisting in the recruiting, selection, orientation, and training of employees;
• Plan and supervise laboratory reagent and consumable purchases in order to keep supplies stocked.

Requirements include a Master’s degree or equivalent in Biology, Biological Sciences or related field and 5 years lab experience as a scientist, research technician/associate, or related position.

Must have the following: 

• 3 years’ experience with integration site analysis and biodistribution and shedding.
• 1 years’ experience in job offered or related field of Laboratory management related to cell and gene therapy processes.