Quality Control Analytical Lead Scientist

Job Code:

Q1031

/

Post Date:

August 10, 2021

JOB DESCRIPTION

The Lead scientist will assist QC management on creating the Quality Documents needed to start the QC lab. Once we start running, the lead will help with scheduling, training, and act as a leader within the QCA group.

RESPONSIBILITIES

  • Assist Quality Control Analytical Supervisor in daily activities and scheduling of QC personnel.

  • Responsible for assisting Quality Control Manager in the creation of all Quality Control Analytical quality systems and implementation of those systems.

  • Carry out Quality Control Assays for Client specific processes.

  • Perform routine inventory.

  • Observe and report any safety issues.

  • 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 which includes the satisfactory execution, follow up, and closure of inspection and audit items to the satisfaction of all parties. 

  • Lead, develop, perform, troubleshoot, and optimize viral vector characterization assays including but not limited to qPCR, ddPCR, SDS-PAGE, Western Blot, ELISAs, AUC, CE-SDS, HPLC, and reporter gene-based cell assays using insect or mammalian cell lines

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

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

  • 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.

  • Other duties as assigned by the Quality Control Manager.

QUALIFICATIONS

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

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