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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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