Supervisor, Quality Control Logistics - Philadelphia, United States - Iovance Biotherapeutics Inc

Iovance Biotherapeutics Inc

Verified Company

Philadelphia, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Overview
Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies.

Iovance is seeking a Supervisor, Quality Control Logistics - Sample Management, who will be responsible for sample inventory management as well as internal and external sample distribution, including storage and shipping of QC samples under appropriate conditions.

The position will be based at Iovance's Cell Therapy Center (iCTC), and will report into the Senior Manager, Quality Control Logistics.

Essential Functions and Responsibilities

Supervision and Development of direct reports (operators), mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence.
Schedule and coordinate daytoday activities, ensuring conformance to the daily schedule.
Perform review of batch documentation and logbooks for completeness and accuracy.
Author and revise documentation, including drafting and approval of SOPs, Sample Plans, Deviations, CAPAs, etc.
Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely feedback to Management.
Manage all aspects of QC Sample Management for raw material, inprocess, and final product samples including sample storage, sample inventory and reconciliation, scheduling, and shipping.
Maintain sample integrity by ensuring that all samples are managed (i.e., stored; handled; shipped) in compliance with procedures, specifications, and cGMP.
Ensure optimal performance of the iCTC QC logistics team through supervision and training.
Ensure optimal vendor performance regarding sample management through adequate oversight.
Provide timely distribution of samples internally at the iCTC, and externally to testing vendors.
Ensure that sample inventory records are maintained and accurate.
Create and/or improve procedures to ensure optimal compliance with cGMP.
Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the logistics function remains in compliance with applicable requirements.
Support audits and inspections as needed.

Required Education, Skills, and Knowledge

Minimum Associate's degree or at least 5 years of relevant cGMP experience.
Experience supervising a team with direct reports.
Experience with inventory and/or logistics in the pharmaceutical industry.
Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
Handson laboratory experience with sample handling, inventory, and cryoshipping.
Strong collaboration, time management, and organizational skills are required.
Proactive, results oriented, selfstarter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
Detailoriented with strong mathematical skills.
Excellent written and verbal communication skills.
Excellent judgment and creative problemsolving skills.
Ability to work successfully in a fastpaced teamoriented environment.
This position is for regular work week hours (M-F); however, due to the nature of cell therapy. manufacturing schedules, must be willing to work weekends, evenings, and holidays, as needed.
Must adhere to Iovance Biotherapeutics core values, policies, procedures and business ethics.
Remains current regarding current Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies Sample Management methods to fully address compliance issues.
Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation (batch records, deviations, etc.). Strong technical writing ability required.
Experience leading "development" initiatives, i.e., training, coaching, learning initiatives.

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 wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
Able to stand and/or walk 90% (and sit 10%) of the scheduled workday, which may include climbing ladders or steps.
Must be able to use near vision to view samples at close range.
Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
Must be able to lift and carry objects weighing 45 pounds.

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