Manufacturing Associate I/II - Downstream

KBI Biopharma • Durham, NC

1d • Onsite

About The Position

The Manufacturing Associate I/II is responsible for the execution of Upstream or Downstream production activities for early and late-phase Cell Culture programs within a GMP environment. The Manufacturing Associate I/II must follow the instructions depicted in SR’s, EPR’s, BR’s, SOP’s and forms. Additionally, must ensure all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP); including ‘Right the First Time’ (RFT). The candidate will maintain a sense of ownership of the production processes, manufacturing environment and facility. They will be exposed to various unit operations including media/buffer preparation, shake flask operations, seed expansion, bioreactor setup and operations, cell culture harvest setup and operations, aseptic technique, chromatography, ultrafiltration, and drug substance filling operations; as well as to analytical tools and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, pH/Conductivity/osmolality meters). Following task execution, the Manufacturing Associate I/II will review the executed production records (SR’s, ERP, and BR’s) to ensure GxP compliance. Manufacture cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations. 35% 30% Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures. 15% 15% Document each task involving manufacturing procedures (i.e. SR’s, EPR’s and BR’s) following GDP at the time of execution. 15% 15% Ensure all items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR) 10% 10% Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities. 10% 10% Participate and be accountable for room 5S. 10% 10% Utilize and perform maintenance on equipment per applicable SOP. 5% 10% Total: 100% Manufacturing Associate I Bachelor’s degree in a related scientific or engineering discipline with 0-2 years’ experience in related GMP manufacturing operations; or high school diploma with 3-5 years’ experience in related GMP manufacturing operations. Manufacturing Associate II Bachelor’s degree in a related scientific or engineering discipline with 2-5 years’ experience in related GMP manufacturing operations; or high school diploma with 4-6 years’ experience in related GMP manufacturing operations.

Requirements

• Manufacturing Associate I Bachelor’s degree in a related scientific or engineering discipline with 0-2 years’ experience in related GMP manufacturing operations; or high school diploma with 3-5 years’ experience in related GMP manufacturing operations.
• Manufacturing Associate II Bachelor’s degree in a related scientific or engineering discipline with 2-5 years’ experience in related GMP manufacturing operations; or high school diploma with 4-6 years’ experience in related GMP manufacturing operations.
• Excellent written and verbal communication skills are required.
• Energetic, motivated and dynamic individual.
• Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

Nice To Haves

• Basic knowledge of cell culture, fermentation or purification unit operations is preferred.
• Experience in single-use platform technology is preferred.

Responsibilities

• Manufacture cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations. 35% 30%
• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures. 15% 15%
• Document each task involving manufacturing procedures (i.e. SR’s, EPR’s and BR’s) following GDP at the time of execution. 15% 15%
• Ensure all items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR) 10% 10%
• Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities. 10% 10%
• Participate and be accountable for room 5S. 10% 10%
• Utilize and perform maintenance on equipment per applicable SOP. 5% 10%

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees