Quality Control Scientist III (Cell Therapy)

Job Code:

Q1070

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JOB DESCRIPTION

The Scientist III will assist QC management on creating Quality Documents and preparing the QC lab for operation. Once operationally ready, the Scientist III will work within the Quality Control Analytical group and cross functionally with the Analytical Development group to perform method transfers, qualifications, validations, and sample testing.

RESPONSIBILITIES

  • Carry out Quality Control Assays for Client specific processes with a high degree of accuracy.

  • Record test results, document processing steps on Quality Control Assays while adhering to good documentation practices (GDP).

  • Experience with: ddPCR, qPCR, ELISA, Microscopy, and flow cytometry.

  • Perform testing in conjunction with laboratory investigations and deviations.

  • Participate in various special projects according to the needs of the department.

  • Participate in the drafting of procedures and / or operating manual, as needed.

  • Participate in the qualification and calibration of laboratory instruments.

  • Collaborate with cross-functional teams to resolve complex method development challenges.

  • Develop and train QC personnel.

  • Responsible for participation in internal audits, client audits and agency inspections of the site. 

  • Participate in method qualification and validation, transfer, and testing.

  • Support internal and external cGMP manufacture and supply of high-quality cell and gene therapy products including, testing, QC release and stability data analyses and method data trending, deviations, out of specification investigations, and Certificates of Analysis creation.

  • Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure Quality Control functions remain in compliance with applicable company requirements and global regulations.

  • Ensure lab is maintained (organized, clean, & properly supplied).

  • Observe and report any safety issues.

  • Communicate with QC leadership and personnel any improvement ideas for processes.

  • Ability to communicate and work in a fast-paced team environment.

  • Maintain a high level of integrity and professionalism when interacting with co-workers and clients.

  • All other duties as assigned by Quality Management.

QUALIFICATIONS

  • BS/BA or greater in sciences, preferably in chemistry, biochemistry, biotechnology, pharmaceutical sciences, or related technical field.

  • 3+ years related GMP experience in biotechnology, chemistry, biochemistry, pharmaceutical, manufacturing, or laboratory environment.

  • Or 7+ years related GMP experience in biotechnology, chemistry, biochemistry, pharmaceutical, manufacturing, or laboratory environment.