Senior Manufacturing Associate

Job Code:

M1037

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Post Date:

October 20, 2021

JOB DESCRIPTION

The successful candidate for senior manufacturing associate will execute the daily manufacturing schedule communicated by the Manufacturing Supervisor to include but not limited to cell expansion, bioreactor operations and purification techniques (TFF and Chromatography) for viral vector manufacturing processes.

RESPONSIBILITIES

  • Lead/Execute operations and act as the main point of contact within the cleanroom

  • Read and understand technical documentation and execute written instruction

  • Possess an advanced understanding and ability to put into practice cGMP principles

  • Possess advanced operational skills, troubleshooting skills and process an advanced knowledge within an aseptic environment, biological safety cabinet or isolator to execute such processes as cell expansion, cell banking, filling, filtration, column chromatography.

  • Possess the ability to train junior level manufacturing associates

  • Plan, organize and maintain material inventory for manufacturing processes

  • Clearly communicate problems and observations with management from other departments

  • Advanced knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Gene/Viral therapy products focusing on Upstream/Downstream Operations

  • Advanced knowledge of the manufacturing process and has the ability to use the latest technologies.

  • Expected work schedule: Any combination to include but not limited to M-F, Alternating Days, 8, 10, and 12 hours shifts.  Ability to work nights, weekends and holidays. 

QUALIFICATIONS

  • AS/BS in Biotechnology, Biology, Chemistry, or equivalent.  Preferred area of study:  Science related discipline.  High School Diploma or Equivalent may be considered with relevant experience.

  • 3-4 years experience in manufacturing (Min. 4 years experience without AS/BS); GMP setting preferred, previous upstream and/or downstream experience preferred.