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Sr. Cell Processing Associate

Company: The Lykan Bioscience Hold
Location: Hopkinton
Posted on: August 6, 2022

Job Description:

Job DescriptionWHO WE ARELykan Bioscience is a fast-growing and innovative contract development and manufacturing organization (CDMO) focused on cell-based therapies. Cell therapy, one of the most transformative innovations in modern biotechnology, holds enormous potential for treating patients suffering from a variety of diseases. We are on a mission to improve patients' lives by innovating and delivering advanced cell-based therapies.OUR PASSIONWorking at Lykan is not just a job, it's an opportunity to work with a great team with diversified backgrounds and top-tier innovative biotechnology companies to contribute to the development and manufacture of revolutionary, life-saving treatments. Our team's passion for patients uniquely defines us. It's not about what we do; it's about why we do what we do. THE LYKAN WAYHere at Lykan, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Innovation, Excellence, Teamwork, Integrity, Trust, and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success, at Lykan we focus on developing our corporate culture, people's development, growth, and the ability to impact patients. ACCELERATING YOUR FUTURE Reporting to the Manufacturing Supervisor, this position's core accountabilities are focused on manufacturing processes related to cell therapies. Activities include aseptic sampling of product in a Biosafety Cabinet (BSC) in an ISO V environment, operation of incubators in an ISO VII environment, as well operating automated, single-use systems for the targeting, expansion and harvesting of cells. The Cell Processing Associate will also collaborate as needed with peers within Manufacturing Sciences and Technology (MST), Quality and Facilities.HOW YOU WILL MAKE AN IMPACT

  • Assist with daily activities of a new cGMP facility by collaborating with Validation, MST, Facilities and Quality departments
  • Perform manufacturing processes on the floor, following validation protocols, batch records and standard operating procedures (SOPs) to ensure safe and compliant operations
  • Perform daily aseptic sampling for cell count, viability and other parameters
  • Perform Equipment and Cleanroom cleaning activities in accordance with established procedures and schedule.
  • Work as part of a team to execute engineering and GMP runs in close collaboration with MST and operations
  • Assist with deviations and root cause analysis in the event of any discrepancies that arise during processing
  • As part of a team, process clinical material in automated systems as part of selection, expansion harvest and wash of cells in single-use systems
  • Adhere to SOPs and cGMP regulations and accurately complete documentation associated with clinical manufacturing
  • Escalate processing and equipment issues as needed
  • Daily review of in-process cGMP documentation for completeness and accuracy Other duties as assigned by Supervisor or ManagerQualifications
    • 6+ years of experience with bachelor's degree in biology or related scientific discipline, or equivalent combination of experience and education
    • Prior experience with biopharmaceutical manufacturing; cell or gene therapy manufacturing
    • Knowledge of the Current Good Manufacturing Practices (cGMP's); 21CFR Partn
    • Excellent skills in Microsoft Word, Excel, and commonly used Manufacturing and Quality systems
    • Excellent technical writing and oral communication skills
    • Driven individual that works well independently and within cross-functional teamsOUR COMMITMENTAll Lykanians embrace the principles of the Lykan Bio culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.Lykan is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

Keywords: The Lykan Bioscience Hold, Worcester , Sr. Cell Processing Associate, Other , Hopkinton, Massachusetts

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