Manufacturing Associate I

KBI Biopharma • Durham, NC

374d

About The Position

The Manufacturing Associate I is responsible for the execution of Upstream or Downstream production activities for early and late-phase Cell Culture programs within a GMP environment. This position operates on a 2-2-3 shift from 7a-7p. The Manufacturing Associate I must follow the instructions depicted in SR's, EPR's, BR's, SOP's and forms, ensuring 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, and 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. Following task execution, the Manufacturing Associate I/II will review the executed production records (SR's, ERP, and BR's) to ensure GxP compliance.

Requirements

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

Nice To Haves

• Associates or Bachelor's degree in a related scientific or engineering discipline
• Biowork certification.
• Experience in single-use platform technology.
• Experience in a CDMO.

Responsibilities

• Manufacture cell culture products per manufacturing batch records 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 procedures (i.e. SR's, EPR's and BR's) following GDP at the time of execution.
• Ensure all materials/items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR).
• Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities.
• Participate and be accountable for room 5S.
• Utilize and perform maintenance on equipment per applicable SOP's.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees