Manufacturing Associate I/ II-Upstream
Durham, NC 
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Job Description

POSITION SUMMARY:
The Manufacturing Associate I/II - Upstream is responsible for the execution of production activities for early and late-phase Cell Culture programs within a GMP environment.

The Manufacturing Associate I/II - Upstream 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 cell culture media preparation, shake flask operations, seed expansion, bioreactor setup and operations, cell culture harvest setup and operations, and aseptic technique; as well as to cell culture analytical tools and general biotechnology auxiliary equipment (pumps, sterile tubing welders and sealers, pH/Conductivity/osmolarity 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.

POSITION RESPONSIBILITIES:

  • Manufacture cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations. The duties require include, but are not limited to, aseptic techniques for cell culture feeding, expansion and counting.
  • 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 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.

MINIMUM 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.
  • Basic knowledge of cell culture or fermentation unit operation 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 face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.


KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
High School or Equivalent
Required Experience
0 to 2 years
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