Manufacturing Associate 3

About the role

This role supports projects which influence manufacturing processes for Drug Product Manufacturing, including training of new colleagues. Maintains compliance of cGMP documents and assists in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

Responsibilities

• Leads, executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control
• Performs in-process testing (pH, conductivity, visual inspection)
• Executes validation protocols according to cGMP Standard Operating Procedures (SOPs)
• Maintains training to perform all required manufacturing activities
• Assists and/or lead cycle counts and manage materials for the assigned manufacturing functional area
• Performs Operations for all aspects of Drug Product (e.g., Parts Washer, Autoclave, Formulation, Filling, and Visual Inspection)
• Assists the lead with tasks in manufacturing activities
• Affords assistance with the coordination of daily shift activities

Requirements

• High School Diploma or GED with 4+ years of direct experience in cGMP manufacturing environment
• Associate's Degree + 2 years direct experience in cGMP manufacturing environment OR Bachelor’s Degree, preferably Life Sciences or Engineering
• Equivalent Military training or experience

Preferred Requirements

• Qualified Experience on unit operation (e.g., Parts Washer, Autoclave Operation, Compounding/Formulation, Filling with Isolator Technology, or Manual/Automated Visual Inspection)
• BioWorks or BTEC Capstone cGMP coursework preferred