Manufacturing Operations Associate III

Cellectis•Raleigh, NC

10d

About The Position

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.

Requirements

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 cG MP 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
Strong, hands on, laboratory skills with pipetting, liquid handling, reagent aliquoting and calculations required.
Working knowledge of quality systems (Change control, Deviations, CAPA) required.
Working knowledge of GMP and/or GLP regulations.
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.
Develops solutions to a variety of problems.
Exercise judgment within defined procedures and practices to determine appropriate actions.
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 as well as effectively within a team-oriented environment.
Flexibi lity 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).
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.

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).