Advanced Accelerator Applications (Italy) - S...
Cell Processing Specialist I, PM Shift
Advanced Accelerator Applications (Italy) - S..., Morris Plains, New Jersey, us, 07950
#LI-Onsite
This role is located on-site in Morris Plains, NJ. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
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.About the Role
Key Responsibilities:Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time. Cell washing with the ability to work with automated equipment.Verification of intermediate process days which include expertise with the wave bioreactor, NC-200 and in-process environmental monitoring.Maintains and prepares equipment/environment for use, proficient in the use of production related IT systems such as SAP, LIMS and MES, documents all steps in the assigned batch record in line with GMP requirements.Conduct all necessary processing/verification steps for the assigned lot with the highest skill level of aseptic technique.Conducts routine and dynamic environmental monitoring as required.Assist on Deviation Investigations and Inspections and participation in assigned qualification/validation activities.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.Additional Specifications:Ability to work different shifts, weekends and overtime will be required. Your shift will be fixed according to business need.Ability to lift 50 lbs., assisted.Ability to stand for an extended period of time.Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials.HS diploma or GED required. A minimum of 1 year experience in cGMP, academic or lab setting with aseptic experience.Associate’s degree or Bachelor’s degree in relevant Engineering or Scientific discipline may be considered in lieu of industry experience.Ability to perform complex calculations and an understanding of scientific notations required.Experience in cell therapy manufacturing preferred.Experience desired in: Aseptic processing in ISO 5 biosafety cabinets.Universal precautions for handling human derived materials in BSL-2 containment areas. Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.The pay range for this position at commencement of employment is expected to be between $28.37 to $43.22/hour; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities.Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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This role is located on-site in Morris Plains, NJ. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
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.About the Role
Key Responsibilities:Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time. Cell washing with the ability to work with automated equipment.Verification of intermediate process days which include expertise with the wave bioreactor, NC-200 and in-process environmental monitoring.Maintains and prepares equipment/environment for use, proficient in the use of production related IT systems such as SAP, LIMS and MES, documents all steps in the assigned batch record in line with GMP requirements.Conduct all necessary processing/verification steps for the assigned lot with the highest skill level of aseptic technique.Conducts routine and dynamic environmental monitoring as required.Assist on Deviation Investigations and Inspections and participation in assigned qualification/validation activities.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.Additional Specifications:Ability to work different shifts, weekends and overtime will be required. Your shift will be fixed according to business need.Ability to lift 50 lbs., assisted.Ability to stand for an extended period of time.Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials.HS diploma or GED required. A minimum of 1 year experience in cGMP, academic or lab setting with aseptic experience.Associate’s degree or Bachelor’s degree in relevant Engineering or Scientific discipline may be considered in lieu of industry experience.Ability to perform complex calculations and an understanding of scientific notations required.Experience in cell therapy manufacturing preferred.Experience desired in: Aseptic processing in ISO 5 biosafety cabinets.Universal precautions for handling human derived materials in BSL-2 containment areas. Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.The pay range for this position at commencement of employment is expected to be between $28.37 to $43.22/hour; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities.Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
#J-18808-Ljbffr