Senior Operations Associate with 15+ years of pharmaceutical field experience. Dependable and detail-oriented, professional adept at quickly identifying and resolving operational issues, implementing new processes and providing exemplary customer service. Possesses excellent organizational, problem-solving, and communication skills.
· Perform process unit operations (i.e. cell culture, purification, aseptic processing, and cryopreservation) according to standard operating procedures and batch records, while recording production data and information in a clear, concise format.
· Perform tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.
· Build strong partnerships with Manufacturing, Engineering, and Quality, and work as part of a cross-functional team to complete production tasks required by shift schedule.
· Support the development of manufacturing processes and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.
· Trained and perform LFG (Laminar Flow Glovebox) processes daily.
· Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
· Cross trained in harvest and wash of cells and injecting the cells with IL-2 while in G-rex in cell culture.
· Take proactive steps in ensuring a safe and secure environment is provided
· Perform all security duties, monitor and manage security systems
· Manage and direct overall performance of the security team which consist of 10+ employees
· Ensure that appropriate security policies, procedures and training is established and followed
GMP, GDP and SOP Training
Aseptic Techniques Microsoft Applications (Word, Excel, Powerpoint)
Leadership and interpersonal skills
Problem solving
Multitasking
Team Support