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Cell Processing Specialist I (PM Shift)

Equipment/Technology Specialist

Equipment and Facilities Specialist

No

Morris Plains, New Jersey, United States

: 365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.<br>The Cell Processing Specialist is responsible for operating and verifying intermediate processing days of patient derived clinical and commercial cellular immunotherapy products. Cell Processing Specialist I will also be responsible for the formulation and verification of all media lots. Due to the nature of the starting material (patient cells) this role requires high level of proficiency and ownership of the process and media formulation.<br>The Cell Processing Specialist I is responsible for cell washing operations and verifying cell processing associates on intermediate processing days of patient derived clinical and commercial cellular immunotherapy products. Cell Processing Specialist I will also be responsible for the formulation and verification of all media lots. Due to the nature of the starting material (patient cells) this role requires high level of proficiency and ownership of the process and media formulation.<br>Your responsibilities include, but not limited to: <br>• Ownership for the processing of the assigned Patient starting material in the clean room environment. <br>o Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time.<br>o Cell washing with the ability to work with automated equipment such as the CS5 <br>o Verification of intermediate process days which include expertise with the wave bioreactor, NC-200 and in process environmental monitoring<br>o Maintains and prepares equipment/environment for use <br>o Proficient in the use of production related IT systems such as SAP, LIMS and MES<br>o Documents all steps in the assigned Batch record in line with GMP requirements<br>o Conduct all necessary processing/verification steps for the assigned lot with highest skill level of aseptic technique.<br>o Conduct all necessary processing/verification steps for assigned lots of media with the highest skill level of aseptic technique<br>o Conducts routine and dynamic environmental monitoring as required<br><br> Assist on Deviation Investigations and Inspections <br> Participation in assigned qualification/ validation activities<br> Responsible for Successful on time completion of required training curriculum comprising of the necessary Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.<br> Perform other duties as assigned; ie. batch record review, process streamline improvements, safety walk-throughs<br><br>***Multiple positions available. The shifts we are hiring for are as follows:<br><br>• Sun-Thurs PM (1pm-9:30pm)<br>• Tues-Sat PM (1pm-9:30pm)<br>[#video#https://www.youtube.com/watch?v=ggbnzRY9z8w{#400,300#}#/video#]<br><br>Vaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network