Manufacturing Associate 3, Drug Product Formulation (1st Shift)

Fujifilm•Holly Springs, NC

15h•Onsite

About The Position

The Manufacturing Associate 3, Drug product is responsible for Component/Parts Preparation, Thawing and Formulation of Drug Substance, Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing, including training of new colleagues. Maintains compliance of cGMP documents and to assist 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.

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 OR
Equivalent Military training or experience

Nice To Haves

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

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
Assists with the coordination of daily shift activities
Performs other duties as assigned