Downstream Manufacturing Associate I​/II; Nights

## Downstream Manufacturing Associate I/II (Nights)
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USA - NC
- Durham
- Hamlin Rd:
Full time:
Posted Today:
R
** JOB SUMMARY**  *
* * 12 hours, 7PM-7AM, 2
* 2
* 3
* * The
** Manufacturing Associate I/II (Nights)
** 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
*** 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  ’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  )
* 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, 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.
* 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.
* 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.
* Ability to add, subtract, multiply, and…