Cell Processing Specialist

Job description

Job Description

Cell Processing Specialist is responsible for end to end processing/ verification of patient derived clinical and commercial cellular immunotherapy products. Due to the nature of the starting material (patient cells) this role requires the highest level of proficiency and ownership.
End to End Ownership for the processing of the assigned Patient starting material in the clean room environment. o Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time. o Maintains and prepares equipment/environment for use o Ability to work with automated cell processing equipment such as Elutra, CS5, Sepax o Knowledgeable in the use of production related IT systems such as SAP and MES o Documents all steps in the assigned Batch record in line with GMP requirements o Conduct all necessary processing/verification steps for the assigned lot with highest skill level of aseptic technique. o sound cell biological decision making  Assist on Deviation Investigations, Change Controls, Safety Inspections and CAPAs  execution of 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.  Perform other duties as assigned for example: Successful completion of assigned PU project initiatives and/or work stream tasks, such as process improvements, efficiencies, Innovation Quality Productivity (IQP).  Maintains an “audit ready” module

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.

Desired profile

Bachelor's degree required. Degree in relevant Engineering or Scientific discipline (preferred) or equivalent work experience.
Advanced degree highly desired. Fluent in speaking / writing in English
Minimum of 2 years of experience in cGMP cell culture manufacturing, experience in cell therapy manufacturing preferred.
Expertise in:
Thawing cryo-preserved product
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 washing processes and automated equipment. o Cell separation techniques and automated equipment. • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
Experience with SAP, MES, Trackwise, etc.strongly preferred
Additional required 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
 Provides innovative solutions to resolve complex issues
 Ability to collaborate with other groups, teams and departments in address process related issues in a highly diverse environment.
 Open-minded
 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.