A small biosimiliars company based in New Jersey is seeking an Operator I/II (Upstream Operations) to join their team in Princeton. The company specialises developing innovative treatments in the areas of immunology and oncology.
The Operator I/II, Upstream Operations, will execute upstream manufacturing operations. The Operator I/II, Upstream Operations, will be required to execute cGMP operations.
- This position will work diligently to meet scheduled timelines, and will work overtime as required to meet production schedule. Weekend, holiday and shift work will be required based on manufacturing schedule as determined by Area Management.
- Performance of Upstream cGMP Operations in accordance with Standard Operating Procedures (SOPs); Master Batch Records (MBRs); Equipment Qualification Protocols; and other applicable instructional documentation.
- Communicates status of operations, process issues, and safety & maintenance issues to Area Management immediately.
- Provides initial review of executed documentation for completeness and accuracy.
- Participate in starting up facility and process equipment.
- Reviews, revises and authors SOPs as directed by area management.
- Management team may assign other responsibilities as required.
Education, Skills and Experience:
- B.S. Life Sciences or equivalent
- 0 - 2 + years industry experience within an upstream biologics drug substance manufacturing environment.
- Limited ability in cGMP bioprocess operations, particularly upstream processes, of mammalian expressed glycoproteins or mAbs, preferred
- Aseptic technique
- Cell culture
- Bioreactor operations
- Excellent communication skills, both verbal and written, and the ability to interface effectively with analytical, process, and business development, manufacturing, sales and marketing, and administration
- Good conceptual, analytical, problem solving, and organizational skills - must be detail-oriented, well organized and able to work independently and in teams
- Meets physical requirements of the job, as follows: must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks
- Must have the ability to stand for long periods of time.
- Works in production environment with exposure to latex and bleach. Potential exposure to equipment movement hazards, noise, dangerous materials, freezer burns, allergens and strong odors. Following proper safety procedures minimizes potential for exposure.
- Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all Personal Protective Equipment (PPE).
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A full job description is available on request.
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