Lot Lifecycle Manager, Quality Control Compliance

Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies.  Iovance is seeking a Lot Lifecycle Manager, Quality Control Compliance, who will be responsible for the long-term sustainability of lot creation, lot release and data management within the Iovance Quality Control Department at both iCTC and IOVA-A.  This role is responsible for identifying and driving continuous improvement in collaboration with QC functional areas, and the creation of programs to ensure turn-around-time (TAT) is met and Certificate of Analyses/Testing are complete on time. In addition, this role will provide strategic planning for collaborating on specification revisions, leading QC lab audit readiness program. This position is responsible for maintaining and driving programs to meet Site Quality Metrics.  This role must have experience in LIMS, problem solving, different operational excellence concepts (Go See, Process Standardization), tier governance, and be a highly collaborative team player who works well in dynamic environments.  The position will report to the Director, Quality Control Compliance.

Essential Functions and Responsibilities

• Monitor and drive change for COA TAT Improvements to support commercial manufacturing.
• Ensure tier management structure, lot release meetings, and lot status is visible for QC throughout the lot lifecycle.
• Update site KPIs, metrics, heat maps, and lean six sigma techniques to measure QC Lot Release performance.
• Utilize SME knowledge of MasterControl and LIMS tools to collaborate with QC leadership to define strategy, plan, and oversee the execution of key initiatives that deliver significant business value.
• Facilitate training and coaching to new and existing employees 

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Minimum (9) years of experience in the biopharmaceutical industry within a cGMP Quality Control role; experience with cell and/or gene therapy products is a plus.
• Experience with Data Management or Lot Release within QC
• Fundamental knowledge of Quality Control operational and laboratory practices including, but not limited to, microbiology, analytical testing, sample management, quality records, and training.
• Advanced proficiency in MS Office (Word, Excel, Powerpoint, Visio)
• Successfully interface with multi-disciplined teams in a global setting
• Extremely detail-oriented with strong written, and verbal communication skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
• Advanced strategic planning and implementation
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Flexible and adaptable style with an eagerness to take on challenges
• Problem solver who not only identifies issues but leads efforts to resolve them

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to Sit for an extended amount of time in front of the computer or biological safety cabinet

Mental:

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline

Work Environment:

• This position will work in both an office and a manufacturing lab setting.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

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