Novartis Farmacéutica
Cell Processing Specialist I, PM Shift
Novartis Farmacéutica, Trenton, New Jersey, United States,
#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 highest skill level of aseptic technique.Conduct all necessary processing/verification steps for assigned lots of media 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 shift, weekends and overtime will be required. Your shift will be fixed according to business need.Ability to work with magnetic field equipment.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, final pay determinations will depend on various factors, including geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits.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.Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives.Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities.The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives.Accessibility & Reasonable AccommodationsThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
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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 highest skill level of aseptic technique.Conduct all necessary processing/verification steps for assigned lots of media 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 shift, weekends and overtime will be required. Your shift will be fixed according to business need.Ability to work with magnetic field equipment.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, final pay determinations will depend on various factors, including geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits.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.Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives.Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities.The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives.Accessibility & Reasonable AccommodationsThe Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
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