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

Employer
Novartis
Location
Morris Plains, NJ
Posted
Aug 06, 2018
Ref
247260BR
Required Education
Bachelors Degree
Position Type
Full time

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 Specialist is responsible for operations on Day 0, cell washing and Harvest processing and for verifying cell processing associates on intermediate processing days of patient derived clinical and commercial cellular immunotherapy products. 

Cell processing specialist will also be responsible for the formulation and verification of all media lots. Due to the nature of the starting material (patient cells) this role requires high level of proficiency and ownership of the process and media formulation.

Major Accountabilities:
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
Day 0, cell washing and Harvest processing with the ability to work with automated equipment such as the CS5 and Sepax
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
Assist on Deviation Investigations and Inspections 
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
Maintains an “audit ready” module 
Perform other duties as assigned; ie. batch record review, process streamline improvements, safety walk-thrus

Key Performance Indicators:
Right First Time Batch Record execution
Conformance to schedule
95% training compliance of all associates
Adherence to attendance guidelines and all safety related procedures
No major or critical audit findings pertinent to the ISO 5 & 7 areas
Manufacturing compliance/adherent to all GDP/GMP principles
Aseptic/Cleanroom behavior in accordance with GMP guidelines

Minimum Requirements

Position will be filled at level commensurate with experience

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

Experience: 
1+ years’ experience in cGMP, cell culture experience preferred
Experience with SAP, MES, Trackwise, etc. preferred

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

Values & Behaviors
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
Open-minded 
Ability to multitask when required
Seek feedback and respond to it through personal change 
Demonstrate a high level of discipline and self-motivation
Maintains composure during stressful situations.
Speak Up Mentality
Ability to resolve conflict professionally
Jointly own problems