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Microbiology Analyst QC CAR-T - 2406180460W

Description

Janssen Pharmaceutical, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control - Microbiology CAR-T Manufacturing (2nd Shift) in Raritan, NJ!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity!

The Microbiology CAR-T Manufacturing QC Analyst is responsible for collaborating with the Operations Team to conduct environmental monitoring within the manufacturing facility. Additional responsibilities in the QC laboratory include environmental monitoring plate reads and endotoxin testing. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and cGMP regulations. They typically work with a team of 5 – 15 other Associates within the functional Quality Control laboratory and the Manufacturing area.

Key Responsibilities:

• Participate in CAR-T manufacturing facility commissioning and qualification.

• Perform compressed gas sampling and Routine Environmental Monitoring of classified areas within the Raritan manufacturing facility.

• Perform endotoxin testing.

• Participate in gown qualification and requalification of personnel.

• Create, review, and approve relevant QC documents, SOPs, and WIs.

• Support Aseptic Process Simulations and visual inspection of components.

• Utilize electronic systems (eLIMS) for execution and documentation of testing.

• Perform peer data review/approval of laboratory data.

• Initiate quality investigations related to environmental monitoring.

• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Qualifications

Education:

• Minimum of a Bachelor’s or equivalent degree required; focused degree in Biological Science or equivalent technical field preferred

Experience and Skills:

Required:

• Minimum two (2) years of relevant work experience

• Experience within the biological and/or pharmaceutical industry

• Microbiology experience related to manufacturing

• Detailed knowledge of Microbiology testing and sampling methods, techniques, and related equipment

• Aseptic processing in ISO 5 cleanroom and/or biosafety cabinets

• Knowledge of cGMP regulations

• Excellent written and verbal communication skills

• Highly organized and capable of working in a flexible team environment with a positive attitude under some supervision

Preferred:

• Knowledge of Microbiology laboratory techniques such as endotoxin testing, sterility testing, bioburden testing, growth promotion testing, and/or microbial isolation

• Experience working with cell therapy

• Knowledge of FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices (GTP)

• Trending using statistical analysis

Other:

• Requires ability to work in an aseptic processing environment (ISO 7 or ISO 8) and adhere to cleanroom gowning procedures

• Requires ability to occasionally lift up to 20 lbs

• Requires ability and flexibility to work 10-hour shifts between the operational hours of 2:00pm - 12:00am or 3:00pm to 1:00am (Sunday-Wednesday or Wednesday to Saturday), provide occasional support on the weekends or other shifts, and accommodate unplanned overtime on little to no prior notice

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be 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.

• Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

• Holiday pay, including Floating Holidays – up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year

The anticipated base pay range for this position is $60,000 to $96,600. This position is eligible for a shift differential (15%) when working the night shifts.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

#CAR-T

Primary Location NA-US-New Jersey-Raritan

Organization Janssen Pharmaceuticals, Inc. (6062)

Travel Yes, 10 % of the Time

Job Function Quality Control

Req ID: 2406180460W