Senior Specialist, QC

Allogene Therapeutics • Newark, NJ

1d • Onsite

About The Position

Allogene is seeking a Senior Specialist, QC to provide scientific technical expertise to the QC analytical laboratory. You will act as a Subject matter Expert (SME) for all cell based-methods including but not limited to potency, cytotoxicity, flow cytometry, qPCR and ddPCR, and immunoassays. You will be responsible for the review and approval of test records and documentation generated from the QC laboratory and other contract testing laboratories (CTLs) as needed. You will support daily laboratory operations, scheduling, training, and method lifecycle related activities including development, optimization, troubleshooting, transfer, and validation of analytical methods. You will perform routine laboratory testing as needed to ensure all operations are completed within agreed upon turn-around time (TAT). You will support deviation investigations, CAPA initiation and completion, and method-related change management as needed. This position reports into the Associate Director, Quality Control and is based out of our Newark, CA location.

Requirements

• Bachelor’s degree in a scientific discipline with at least 8 years of experience performing relevant activities including working in a GMP environment
• Broad knowledge and experience performing cell-based assays, Flow cytometry, ELISA, qPCR, and ddPCR
• Experience in analytical method development/validation/transfer and reagent qualification and maintenance
• Ability to troubleshoot and optimize methods as needed
• Experience conducting unexpected/OOS investigations and CAPA initiation
• Thorough understanding of regulatory requirements for drug substance and drug product testing
• Previous experience in GMP audits and inspection-related supports
• Ability to solve problems of moderate to complex level
• Proficient in Microsoft Office Suite and Statistical software (JMP)
• Strong communication and collaboration skills to effectively interact with cross-functional teams
• Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team
• Candidates must be authorized to work in the U.S.

Nice To Haves

• advanced degree preferred

Responsibilities

• Serve as a Subject Matter Expert (SME) for QC test methods including flow cytometry, cell-based assays, ELISA, qPCR and ddPCR and demonstrate ability to design and develop methods as needed
• Demonstrate expertise in the operation, maintenance and troubleshooting of instruments; trains and qualifies junior laboratory members on test methods
• Lead method validation and transfer activities, by participating in the design and authoring of validation protocols/reports and support execution of validation and transfer exercises as needed
• Define and execute critical reagent qualification programs and help in establishing and maintaining the critical reagents qualification program for all methods as needed
• Support the implementation of reference standards and controls programs for analytical methods and monitor analytical methods performance and escalate any issue
• Troubleshoot/optimize analytical methods as needed; identify opportunities to improve efficiency
• Support Associate Director by assisting in laboratory operations, including scheduling, training and troubleshooting to ensure all operations are in full compliance with applicable SOPs and safety guidelines
• Perform QC analytical testing to support the release and stability of final products as needed
• Review and approves test records and documentation generated from the QC laboratory and other CTLs, evaluate data, and interpret trends as needed
• Ensure laboratory maintenance and cleaning activities are performed in a timely manner
• Perform technical investigations of discrepancies, Out Of Specification (OOS), Unexpected results and support the implementation of corrective and preventative actions
• Assist with addressing questions during GMP audits and support inspection-related needs as required
• Support the team’s responsibilities for the performance of all testing and/or for regulatory requirements pertinent to the QC laboratory
• May represent QC at operational and cross-functional meetings
• Other duties as assigned

Benefits

• an annual performance bonus
• equity
• health insurance
• generous time off (including 2 annual holiday company-wide shutdowns)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 101-250 employees