Job Description

Must Haves:

• Bachelor’s degree in a related scientific or engineering discipline and 0-2 years’ experience in related cGMP manufacturing operations; or high school degree and 3-5 years’ experience, or equivalent.
• Excellent written and verbal communication skills are required.
• Energetic, motivated, and dynamic individual
• Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

Pluses:

• Basic knowledge of upstream (cell culture or fermentation), downstream (purification and bulk filling) or manufacturing support unit operations
• Experience in single-use technology platform

Job Description:

Insight Global is seeking Manufacturing Associates in the Raleigh/Durham area for a large biopharmaceutical client. The Manufacturing Associate will be responsible for upstream unit operations (seed expansion, bioreactor operations, cell culture harvest), downstream unit operations (chromatography, tangential flow filtration, viral inactivation, and bulk filling) and/or manufacturing support operations (solution preparation, assembly preparation, parts wash, and autoclave) activities. Following task execution, the Manufacturing Associate will review the executed production records and logbooks to ensure GxP compliance.

Responsibilities:

• Manufacture bulk intermediates and drug substances per manufacturing batch records and in compliance with quality standards, company policies and current regulations.
• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
• Document each task involving manufacturing records and logbooks following GDP at the time of execution.
• Utilize and perform maintenance on equipment per applicable SOP.
• Ensure all materials are issued and accounted for during the execution of a record (i.e. SR, EPR and BR).
• Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities.
• Participate and be accountable for workplace organization (5S).

Shift: 7pm - 7am, 2-2-3 schedule

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