Cell Processing Associate CAR-T Cell Therapy Morris Plains, NJ

Job description

Job Description

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field. We're committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage.

The Cell Processing Associate is responsible for intermediate processing of patient derived clinical and commercial cellular immunotherapy products. Due to the nature of the starting material (patient cells) this role requires basic proficiency and ownership of the process.

Intermediate ownership for the processing of the assigned Patient starting material in the clean room environment.

Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time.

Maintains and prepares equipment/environment for use.

Ability to work with automated cell processing equipment such as the wave bioreactor.

Ability to perform in process operations such as: bioreactor sampling, static sampling and in process environmental monitoring.

Knowledgeable in the use of production related IT systems such as SAP and MES.

Documents all steps in the assigned Batch record in line with GMP requirements.

Conduct all necessary processing steps for the assigned lot with highest skill level of aseptic technique.

Assist with deviation investigations and inspections.

Participation in assigned qualification/ validation activities, as necessary.

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.

Maintains an “audit ready” module.

Perform other duties as assigned; ie. batch record review, process streamline improvements, safety walk-thrus.
Posting Title

Cell Processing Associate CAR-T Cell Therapy Morris Plains, NJ

Desired profile

Minimum requirements

Position will be filled at level commensurate with experience.

Bachelor’s degree in relevant Engineering or Scientific discipline (preferred) or equivalent work experience.

1 year of experience in cGMP 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.

Cell expansion using incubators and single use bioreactors.

Cell automated equipment.

Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.

Other Qualifications:

Alternate shifts, weekends and overtime will be required.

Ability to work with magnetic field equipment.

Ability to lift 50 lbs. unassisted.

Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials.

Ability to adapt and learn new and complex equipment and systems and detailed scientific content.

Ability to collaborate with other groups, teams and departments in addressing process related issues in a highly diverse environment.
Job Type

Full Time
Country

USA
Work Location

Morris Plains
Functional Area

Technical Operations
Division

Novartis Technical Operations
Business Unit

NTO BTDM
Employment Type

Regular
Company/Legal Entity

Novartis Pharmaceuticals
EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.