Lentivirus Manufacturing Operator

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We are searching for the best talent forLentivirus Manufacturing Operator.
Be part of the manufacturing operations team responsible for production of Lentivirus vector for the autologous CAR-T products in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.

Duties / Responsibilities:

• Perform process unit operations according to standard operating procedures and batch records, and record production data and information in a clear, concise, format according to Good Documentation Practices (GDP).
• Perform tasks on time in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Execute production activities common to cell culture in shake flasks and wave bioreactor, cell counting methods (i.e. Vi-Cell), thawing, passaging, aseptic technique/processing, chromatography columns or filtration(TFF, DF), filter integrity test, GE AKTA systems and/or microfiltration/ultrafiltration systems, purification, automated filler (i.e.FP50) and sterile filling using appropriate techniques.
• Perform tasks related to single use bioreactor operations including bioreactor setup, sampling and monitoring, and disassembly.
• Work in a team based, cross-functional environment to complete production tasks required by shift schedule.
• Aid in the development of manufacturing processes including appropriate documentation.
• Drive continuous improvement of manufacturing operations leveraging own observation as well as input of team members.
• Handle virus and human derived materials in containment areas.

Qualifications:

EDUCATION AND EXPERIENCE:

• A High School diploma with a 1-2 years of related work experience
• OR
• An Associate’s or Bachelor's degree in a related field (i.e. Chemical Engineering, Biological Sciences, Chemistry or Biochemistry) is required.
• Experience in manufacturing, maintenance, quality, testing, or engineering areas is preferred.
• Knowledge of current Good Manufacturing Practices (cGMP) is preferred.
• Experience in the Pharmaceuticals or Biopharmaceuticals industry is preferred.
• Experience in an aseptic and manufacturing environment is preferred.
• Proficiency in English (verbal and written), as well as, good communication skills are required.
• Ability to lift a minimum of 25 lbs. and to stand for a long period of time are required.
• Basic proficiency with Microsoft Office tools (Word, Excel, PowerPoint and Outlook) is required.
• Availability to work in a day shift is required.
• Ability to accommodate changes in the schedule including working in other shifts as per operational needs is required.
• This position will be based in Raritan, NJ and requires up to ten percent (10%) of domestic travel.