Manufacturing Operations Associate III

Who We Are:
Cellectis is a clinical-stage biopharmaceutical company focused on developing a new generation of cancer immunotherapies to target and eradicate cancer cells. Cellectis utilizes gene-edited T-cells (UCART) to create cost-effective “off-the-shelf” products from healthy donors that can be immediately made available to patients across all geographies.

By capitalizing on our 21 years of expertise in gene editing and built on our flagship trademark technology and pioneering electroporation system, we seek to use the power of the immune system to address unmet therapeutic needs. Using life-science-focused, pioneering genome engineering technologies, our goal is to create innovative products in multiple fields and with various target markets.

Cellectis is on an incredible journey and we are looking for passionate individuals to join us on this important mission and in our commitment to a cure.

Who We Are Looking For:
The Manufacturing Operations Associate III will be responsible for processes, cultures, cryopreserves, and otherwise manipulate cell products using aseptic techniques, according to written Standard Operating Procedures, in accordance with facility GMP and GLP practices. 

Responsibilities:

• Cell/tissue culture and manipulation using aseptic techniques, as well as cleaning and sanitization activities to support the maintenance and ongoing use of the processing and filling spaces and equipment 
• Manipulate products according to established standard operating procedures and batch records such as enrichments, depletions, cell expansions, or volume reductions to achieve predetermined endpoints
• Perform any and all required processing and testing required for the production and assessment of safe and efficacious products 
• Proficiently function within cleanroom environments, ensuring personal and product safety 
• Produce accurate and clear documentation in accordance with Good Documentation Practices and Good Manufacturing Practices 
• Proficiently performs testing and assesses product content and safety according to company’s established procedures 
• Cryopreservation of cellular products using DMSO solution and controlled-rate freezers 
• Proficiently operate and maintain equipment according to designed procedures 
• Performs the monitoring and maintenance of critical equipment such as ultra-cold freezers, storage tanks, refrigerators, freezers, incubators, and other process equipment. 
• Participates in clinical trial support and studies, may include but not be limited to sample preparation, sample shipping, media and reagent preparation 
• Applies high level understanding of processing principles and techniques to use good judgement and make appropriate decisions in the processing environment 
• Notifies Management of any deviation that may occur during processing or during equipment maintenance 
• Performs investigations for deviations and completes deviations and CAPAs (Corrective and Preventive Actions) in a timely manner 
• Supports outcomes of investigations including ownership and implementation of CAPAs (Corrective and Preventive Actions) 
• Initiates Change Controls for processes, documentation, equipment, etc. 
• Drafts and reviews SOPs and Master Batch Records (MBRs) related to the manufacturing of cellular batches according to GMP practices 
• Revises and updates documentation as needed to support ongoing compliance and process improvement activities 
• Perform and/or assist in the training and development of other Manufacturing Operations Associates 
• Supports or leads technology transfers into GMP manufacturing operations 
• Participates in the on-call program as requested 
• May onboard and train new colleagues and/or provide direction to other Manufacturing Operations Associates within the Manufacturing team(s).

EDUCATION AND EXPERIENCE:

• Associate’s or Bachelors’ degree in Biology or related life science degree preferred
• Minimum 4-6 years manufacturing experience in clinical laboratory, hematology, blood banking, and/or within a cell and gene therapy / biologics cGMP manufacturing facility. 
• Cell processing experience, including aseptic techniques and isolator experience, preferred.
• Experience working in classified iso-8 or higher and/or with isolators a plus   

Core Competencies: