Lentivirus Manufacturing Operator

Johnson & Johnson Co.; Raritan (NJ); On-site; USD 43,000 - 70,000; Full time

Job summary

Johnson & Johnson is seeking a Lentivirus Manufacturing Operator in Raritan, NJ to support production of lentivirus vectors for autologous CAR-T products in a controlled cGMP cleanroom. The role requires adherence to GDP documentation, safety standards, and cross-functional teamwork.

Responsibilities include operation of cell culture in shake flasks and bioreactors, purification steps, in-process testing, and maintenance of automated filling and sterile processing.

Qualifications

• High school diploma or equivalent with 1–2 years related experience.
• Associate or Bachelor's degree in Chemical Engineering, Biological Sciences, Chemistry or Biochemistry preferred.
• Experience in manufacturing, quality, testing or engineering is preferred.
• cGMP knowledge and pharmaceuticals/biopharmaceuticals exposure is preferred.

Responsibilities

• Perform process unit operations according to SOPs and batch records with GDP-compliant documentation.
• Adhere to safety policies and cGMP requirements; complete tasks on schedule.
• Operate cell culture processes in shake flasks and wave bioreactor; perform related analytical steps.
• Handle single-use bioreactor operations including setup, sampling and monitoring.

Skills

Administrative Support

Agile Manufacturing

Analytics Dashboards

Data Compilation

Communication

GMP Knowledge

Operational Excellence

Process Optimization

Regulatory Compliance

Self-Awareness

Education

High School diploma

Associate/Bachelor's degree in related field

Tools

Microsoft Office

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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

Job Description:

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:

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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

#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

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)).

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