Supervisor, Quality Control Logistics - Sample Management
Iovance Biotherapeutics
- Philadelphia, PA
- Permanent
- Full-time
- 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 day-to-day 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, in-process, 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.
- 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.
- Hands-on laboratory experience with sample handling, inventory, and cryo-shipping.
- Strong collaboration, time management, and organizational skills are required.
- Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
- Detail-oriented with strong mathematical skills.
- Excellent written and verbal communication skills.
- Excellent judgment and creative problem-solving skills.
- Ability to work successfully in a fast-paced team-oriented 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.
- 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.