Lentivirus Manufacturing Operator

6062-Janssen Pharmaceuticals, Inc. Legal Entity; Raritan (NJ); Sur place; USD 43 000 - 70 000; Plein temps

Résumé du poste

Johnson & Johnson in Raritan, NJ is seeking a Lentivirus Manufacturing Operator to support production for autologous CAR-T products in a cGMP cleanroom. You will perform unit operations in cell culture and purification, document data per GDP, work in a cross-functional team, and help drive process improvements while adhering to safety and quality standards.

Requirements include a 1–2 year related experience or an associate/bachelor’s degree, and the ability to lift 25 lbs, with up to 10%

Qualifications

• High School diploma with 1–2 years related work experience or an Associate/Bachelor’s in a related field.
• Experience in manufacturing, maintenance, quality, testing, or engineering preferred.
• Knowledge of current Good Manufacturing Practices (cGMP) preferred.
• Proficiency in English and strong communication skills required.

Responsabilités

• Perform process unit operations per SOPs and record data per GDP.
• Meet production timelines while following safety and cGMP policies.
• Operate cell culture in shake flasks and wave bioreactor; use Vi-Cell, AKTA, TFF/DF.
• Work in a cross-functional team to complete shift-based tasks.
• Assist in developing manufacturing processes with proper documentation.
• Drive continuous improvement in manufacturing operations.
• Handle virus and human-derived materials in containment areas.

Connaissances

Administrative Support

Agile Manufacturing

Analytics Dashboards

Chemistry

Manufacturing

CMC

Communication

Data Compilation

Data Savvy

Execution Focus

Gap Analysis

GMP

Operational Excellence

Plant Operations

Process Optimization

Process Oriented

Project Administration

Regulatory Compliance

Self-Awareness

Formation

High School diploma

Associate’s or Bachelor's degree

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow,and profoundly impact health for humanity.Learn more at jnj.com

Job Function: Supply Chain Manufacturing Job Sub Function: Manufacturing Pharmaceutical Process Operations Job Category: Business Enablement/Support All Job Posting Locations: Raritan, New Jersey, United States of America

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Lentivirus 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

• 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.

Required Skills

#LI-Onsite Required Skills: Preferred Skills: Administrative Support, Agile Manufacturing, Analytics Dashboards, Chemistry, Manufacturing, and Control (CMC), Communication, Data Compilation, Data Savvy, Execution Focus, Gap Analysis, Good Manufacturing Practices (GMP), Operational Excellence, Plant Operations, Process Optimization, Process Oriented, Project Administration, Regulatory Compliance, Self-Awareness

Pay Transparency

The anticipated base pay range for this position is : $43,050.00 - $70,035.00

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow,and profoundly impact health for humanity.Learn more at https://www.jnj.com/. Do Not Sell or Share My Personal Information Limit the Use of My Personal Information