The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help define the regulatory strategy for our innovative next generation technology for cellular therapy. This position will play a substantial role researching regulations, defining and implementing the regulatory strategy and engaging with health authorities to effectively

Aseptic Control Operators are responsible for the cleaning, changeover, setup, startup, operation, and breakdown of production lines. Additionally, they may be assigned tasks related to the general upkeep of the area, such as unloading ovens and sterilizers, performing routine cleaning, and performing minor maintenance. All of these activities are governed by strict proce

POSITION SUMMARY The Master Technician provides direct engineering and maintenance support for processes and equipment used to compound, fill, process, sterilize and finish pharmaceutical products in a cGMP compliant manner. He/She will collaborate with multiple site functions to implement new equipment and processes. The incumbent is a key contributing member to the manu

Responsible for the full set up and safe, clean, efficient and consistent operation of Inspection and Packaging equipment and all associated documentation. Must be knowledgeable of and able to operate all packaging lines with HMI applications. This position requires extensive amounts of leadership, decision making and coordination of co workers. This position reports to t

Responsible for the full set up and safe, clean, efficient and consistent operation of Inspection and Packaging equipment and all associated documentation. Must be knowledgeable of and able to operate all packaging lines with HMI applications. This position requires extensive amounts of leadership, decision making and coordination of co workers. This position reports to t

Responsible for the full set up and safe, clean, efficient and consistent operation of Inspection and Packaging equipment and all associated documentation. Must be knowledgeable of and able to operate all packaging lines with HMI applications. This position requires extensive amounts of leadership, decision making and coordination of co workers. This position reports to t

Responsible for the full set up and safe, clean, efficient and consistent operation of Inspection and Packaging equipment and all associated documentation. Must be knowledgeable of and able to operate all packaging lines with HMI applications. This position requires extensive amounts of leadership, decision making and coordination of co workers. This position reports to t

Responsible for the full set up and safe, clean, efficient and consistent operation of Inspection and Packaging equipment and all associated documentation. Must be knowledgeable of and able to operate all packaging lines with HMI applications. This position requires extensive amounts of leadership, decision making and coordination of co workers. This position reports to t

Responsible for the full set up and safe, clean, efficient and consistent operation of Inspection and Packaging equipment and all associated documentation. Must be knowledgeable of and able to operate all packaging lines with HMI applications. This position requires extensive amounts of leadership, decision making and coordination of co workers. This position reports to t

Responsible for the full set up and safe, clean, efficient and consistent operation of Inspection and Packaging equipment and all associated documentation. Must be knowledgeable of and able to operate all packaging lines with HMI applications. This position requires extensive amounts of leadership, decision making and coordination of co workers. This position reports to t

Responsible for the full set up and safe, clean, efficient and consistent operation of Inspection and Packaging equipment and all associated documentation. Must be knowledgeable of and able to operate all packaging lines with HMI applications. This position requires extensive amounts of leadership, decision making and coordination of co workers. This position reports to t

POSITION SUMMARY Position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in responsible to deviations noted. Assures compliance to SOP's and cGMP's. Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas. Responsibilities

Responsible for the full set up and safe, clean, efficient and consistent operation of Inspection and Packaging equipment and all associated documentation. Must be knowledgeable of and able to operate all packaging lines with HMI applications. This position requires extensive amounts of leadership, decision making and coordination of co workers. This position reports to t

Responsible for the full set up and safe, clean, efficient and consistent operation of Inspection and Packaging equipment and all associated documentation. Must be knowledgeable of and able to operate all packaging lines with HMI applications. This position requires extensive amounts of leadership, decision making and coordination of co workers. This position reports to t

POSITION SUMMARY Responsible for the accurate weighing, checking and verification when mixing specific chemical compounds for product formulation. Performs monitoring of mixing and ancillary support equipment throughout formulation and filling and executes calibrations and preventive maintenance activities. Routinely complies with cGMP's, departmental SOP's and company po