Manager, Quality Control - Microbiology

Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Manager, Quality Control (QC) Microbiology, who will be responsible for oversight of day-to-day microbial QC operations at Iovance’s Cell Therapy Center (iCTC). The position will report to the Senior Director, Quality Control.

S/he will be experienced working in a GMP-regulated environment and will have a good understanding of QC microbiology test methods and environmental monitoring. S/he must be able to apply phase appropriate cGMPs and regulatory requirements in the product development life cycle, including but not limited to: lot release and stability testing, method qualification and validation, method technology transfers, and writing/review of QC procedures.

Specific Responsibilities

• Lead investigations for out-of-specification test results, corrective actions, and verification of effectiveness.
• Manage several analysts at the iCTC in the day-to-day cGMP QC testing of drug products for lot release and stability; Manage microbial testing at contract laboratories
• Support career development of microbiology team members.
• Author, review, and approve SOPs, protocols, reports, specifications, and other quality control documents.
• Ensure trend analysis and trend reports for environmental monitoring data are performed timely.
• Establish positive working relationships with internal and external partners, and implement processes for performance management, including routine meetings, onsite visits, performance monitoring, and issue notification
• Support problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as needed
• Manage the technical transfer, qualification, and validation of microbiology test methods for in-process materials, lot release, and/or stability, as needed
• All duties are performed with minimal supervision and oversight
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment
• Support site qualification/validation/commissioning activities, as needed.
• Ensure trend analysis and trend reports for environmental monitoring data are performed timely.
• Oversee the maintenance and built of a microbial identification database for all in-house isolates recovered from the various monitoring programs.
• Serve as a qualified trainer, as needed.
• Support of site contamination control programs.
• Manage the environmental monitoring program for the facility
• Support product stability programs including generation of stability protocols, execution of stability testing, stability data analysis, and final reporting of stability data.

Education And Qualifications

• Successfully interface with multi-disciplined teams in a global setting
• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Broad knowledge of biological drug development with respect to Quality Control
• Problem solver who not only identifies issues but leads efforts to resolve them
• Minimum (8) years of experience in the biopharmaceutical industry within a Quality Control role; experience with cell and/or gene therapy products is a plus
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Flexible and adaptable style with an eagerness to take on challenges
• Experience managing a team a plus
• Demonstrated ability to manage external partners with respect to quality control activities
• Extremely detail-oriented with strong analytical, written, and verbal communication skills

Physical Requirements

• Sit for an extended amount of time in front of the computer

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