Posted to MedZilla on 5/25/2017


United States, Operator I/II, Downstream Operations US_SC_HC_11866-MZ


A small biosimiliars company based in New Jersey is seeking an Operator I/II (Downstream Operations) to join their team in Princeton. The company specialises developing innovative treatments in the areas of immunology and oncology. 

Job Role:

This Operator I/II, Downstream Operations role will execute downstream manufacturing operations. The Operator I/II, Downstream Operations, will be required to execute cGMP operations.

Role Responsibilities:

  • 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 Downstream 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.
  • 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 a downstream biologics drug substance manufacturing environment.
  • Limited ability in cGMP bioprocess operations, particularly downstream processes, of mammalian expressed glycoproteins or mAbs, preferred
    1. Chromatography
    2. Tangential flow filtration
  • 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

Physical Requirements:

  • 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).

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying, please upload your CV on our website - 
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. 

Please visit our website at


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.