Manufacturing Operations Associate II

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 II will be responsible for processes, cultures, cryopreserves, and otherwise manipulates cell products using aseptic techniques, according to written Standard Operating procedures, in accordance with facility GMP and GLP practices. The position will be under the supervision of the Operations Supervisor and/or Manager.

Responsibilities:

• Responsibilities include, but are not limited to, 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
• Performs any and all required processing and testing required to produce and assess safe and efficacious products
• Proficiently functions within cleanroom environments, ensuring personal and product safety
• Consistently produces documentation with accuracy and clarity in accordance to Good Documentation Practices and Good Manufacturing Practices
• Cryopreservation of cellular products using DMSO solution and controlled-rate freezers
• Proficiently operate and maintain equipment according to designed procedures
• Contributes to the monitoring and maintenance of critical equipment such as ultra-cold freezers, isolators, refrigerators, freezers, incubators, and other process equipment.
• Participates in supporting cross-department studies, may include but not be limited to sample preparation, media and reagent preparation.
• Applies a level of 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
• Assist in Performing investigations for deviations in a timely manner
• Supports outcomes of investigations including ownership and implementation of CAPAs (Corrective and Preventive Actions)
• Revises and updates documentation such as SOPs and BPRs as needed to support ongoing compliance and process improvement activities
• Assist in the training and development of junior Associates
• Supports technology transfers into GMP manufacturing operations
• Participates in the on-call support as requested.
• Support batch operations that extend outside of normal business hours as requested. May provide direction to Manufacturing Associates I and II employees with the Clinical Manufacturing department(s).

EDUCATION AND EXPERIENCE:

• Associate’s or Bachelors’ degree in Biology or related life science degree preferred.
• Minimum 2-3 years manufacturing experience in clinical laboratory, hematology, blood banking, and/or a cGMP manufacturing facility required.
• Working knowledge of quality systems (Change control, Deviations, CAPA) required.
• Cell processing experience preferred.
• Aseptic technique experience preferred.
• Working knowledge of GMP and/or GLP regulations preferred.
• Experience working in classified iso-8 or higher and/or with isolators a plus.
• Associate’s or Bachelors’ degree in Biology or related life science degree preferred.
• Minimum 2-3 years manufacturing experience in clinical laboratory, hematology, blood banking, and/or a cGMP manufacturing facility required.
• Cell processing experience preferred.
• Working knowledge of quality systems (Change control, Deviations, CAPA) required.
• Aseptic technique experience preferred.
• Working knowledge of GMP and/or GLP regulations preferred.
• Experience working in classified iso-8 or higher and/or with isolators a plus.

Core Competencies:

• Laboratory skills with pipetting, liquid handling, reagent aliquoting and calculations required.
• Able to carry out responsibilities with little instructions on routine work and with detailed instructions on new projects or assignments.
• Able to work on problems of moderate scope where analysis of a situation/data requires review of a variety of factors.
• Exercise judgment to determine appropriate actions within defined procedures and practices.
• Analytical and problem-solving skills.
• Detail oriented with strong organizational skills.
• Strong written and oral communication skills.
• Ability to prioritize and multi-task is essential.
• Must be able work independently and as well as effectively within a team-oriented environment and ability to work on complex problems with others.
• Flexible and able to adapt to company growth and evolving responsibilities.
• Must be able to work during weekends, holidays and as required by the company when scheduled in advance.
• Relevant computer skills (Microsoft Office, Outlook) preferred.

Physical Requirements:

• Must be willing and able to function within cleanroom environments, ensuring personal and product safety.
• Communicates with others on a daily basis to exchange information.
• Requires the ability to sit or stand at a computer or workstation for long stretches of time; typing, operating lab/manufacturing equipment.
• Frequently operates a computer, office productivity machinery, operate lab/manufacturing equipment.
• The person in this position needs to occasionally move about inside the office/lab-manufacturing environment to access file cabinets and office/lab equipment.
• May occasionally lift objects up to five pounds.