KBI: US - Manufacturing Associate II

KBI: US - Manufacturing Associate II page is loaded## KBI: US - Manufacturing Associate II locations:
USA - NC - Durham - Hamlin Rdtime type:
Full time posted on:
Posted Yesterday job requisition :
RThe 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,  ’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  ’s) to ensure GxP compliance.

JOB RESPONSIBILITIES Responsibility Approximate % of TimeMA II Manufacture cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations 30%
Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures. 15%
Document each task involving manufacturing procedures (i.e. SR’s, EPR’s and  ’s) following GDP at the time of execution. 15%
Ensure all items are issued and accounted for during the execution of a record (i.e. SR, EPR and  ) 10%
Demonstrate and apply understanding of current Good Manufacturing Practices (cGMP) and how they apply to specific tasks and responsibilities. 10%
Participate and be accountable for room 5S. 10%
Utilize and perform maintenance on equipment per applicable SOP 10%
Total: 100%
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, 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 face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

Language Ability Fluent in English language both reading and writing. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals, batch and production records. Ability to write routine reports and correspondence. Ability to speak effectively before groups of employees of organization.

Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Math Ability Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs.

Physical Demands Standing and sitting for long periods of time may be required ting, pushing, and pulling may be required for stocking and movement of equipment. The use of ladder may be required when setting up bioreactors.

Computer Skills MS Office, ERP, EDMS, production equipment software, other

Equipment Use Examples include Biosafety Cabinets, Incubators, Single Use Bioreactors, Chromatography Columns/Skids, Ultrafiltration Skids,…