Senior Specialist, Quality Control Analytical Testing

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PURPOSE AND SCOPE OF POSITION:

The QC Senior Scientist is responsible for supporting the analytical testing at QC Analytical Testing department at the CAR T manufacturing facility during clinical and commercial phases.  This department is responsible for flow-cytometry and molecular based testing for stability, validation, critical reagent qualification, training, and other critical support as needed. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot.

This is Wed-Sat day shift.

REQUIRED COMPETENCIES (Knowledge, Skills, and Abilities):

• Advanced hands-on experience with various analytical techniques including flow-cytometry, molecular techniques and scientific knowledge in the characterization and transfer of pharmaceutical products.
• Advanced ability to accurately understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• Advanced technical writing skills, problem-solving ability/mentality, technically adept and logical thinking.
• Ability to represent the interests of the group on cross-functional teams.
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Ability to work with management locally and globally.
• Advanced ability to communicate effectively with peers, department management and cross-functional peers.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree or equivalent required, preferably in science.
• Advanced Degree preferred.
• 2-4 years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
• Experience working with sterile cell culture, polychromatic flow-cytometry panels, flow-cytometry data analysis, ELISA, and qPCR preferred.

DUTIES AND RESPONSIBILITIES:

Perform testing of the QC Analytical Testing Department including:

• Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
• Perform cell based in-vitro flow experiment, ELISA, qPCR to assess critical regent concentration.
• Capable of handling complex issues and solving problems with only general guidance.
• Prepare and present continuous improvement projects to management.
• Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
• Complete all work in a timely manner.

Perform peer review of testing data.

• Review all data in accordance with applicable procedures and cGMP requirements.
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
• Complete all reviews in accordance with required release timelines.
• Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.

Support document revision, project, CAPA, and investigation/deviation tasks.

• Perform assigned tasks within a CAPA, deviation, or project
• Participate in complex projects and continuous improvement efforts.
• Take a leadership rol