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Department: Operations

Job Title: Manufacturing Associate, I/II Purification, N0835-R

Description:
Under moderate supervision, perform technical procedures related to the column chromatography and aseptic filling of pharmaceutical products.

ESSENTIAL DUTIES:

  • Prepare, pack, process, and clean chromatography columns.
  • Prepare buffers and other cleaning solutions.
  • Ultra filtration and Diafiltration.
  • Aseptic filling.
  • Dispose of waste products.
  • Sampling and performance of in-process measurements.
  • Operation of analytical instruments - pH meter, Conductivity meter, UV meter, and Spectrophotometer.
  • Perform general maintenance of equipment (assembly, disassembly, trouble-shoot and equipment problems).
  • Perform overall cleaning of plant, including floors, benches, columns, and equipment.
  • Record and document all procedures.
  • Perform trouble-shooting of instruments and processes.
  • Perform technical training on the production floor and in a classroom setting.
  • Execution of validation protocols.

OTHER RESPONSIBILITIES:

  • May contribute to scientific journal publications.
  • Other projects as assigned.
  • Comply with XOMA's Policies and Procedures.

Job Requirements:
Education and/or experience
Bachelor's degree (B.A.) in Cell Biology, Biochemistry, Chemistry, Biology, or a related field from a four-year college or university with 1 - 3 years relevant experience;

Special skills/knowledge

  • Knowledge of cGMP.
  • Must be able to work independently and as part of a team.
  • Excellent organizational and good record keeping skills.
  • Effective communication skills.

Language skills

  • Ability to read and interpret documents such as safety rules, standard operating procedures, operating and maintenance instructions, and procedure manuals.
  • Ability to write routine reports and correspondence, keep legible records.

Mathematical skills

  • 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 bar graphs.

Reasoning ability

  • Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.
  • Ability to deal with problems involving a few concrete variables in standardized situations.

Physical demands

  • While performing the duties of this job, the employee is required to stand, walk, sit, talk or hear, use hands to handle, work at a video display terminal.
  • Specific vision abilities required by this job include color vision, close vision, and the ability to adjust focus.

Work environment

  • While performing the duties of this job, the employee is occasionally exposed to toxic or caustic chemicals, or radiation or biohazardous waste.
  • The noise level in the work environment is usually moderate.

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