Lead Aseptic Manufacturing Technician - Night Shift

Iovance Biotherapeutics, Inc.; Philadelphia (Philadelphia County); On-site; USD 60,000 - 100,000; Full time

Job summary

An innovative firm in the biopharmaceutical sector is seeking a Lead Aseptic Manufacturing Technician for the Night Shift. This pivotal role involves overseeing GMP cell therapy manufacturing processes and ensuring strict adherence to aseptic techniques within cleanroom environments. The ideal candidate will have a strong background in biopharmaceutical manufacturing, excellent leadership skills, and a commitment to safety and quality standards. Join a team dedicated to advancing cancer immunotherapies and making a significant impact in the field of immuno-oncology. If you thrive in dynamic environments and are passionate about improving patient outcomes, this opportunity is for you.

Qualifications

• 3+ years in GMP biopharmaceutical manufacturing with aseptic technique expertise.
• Strong leadership and troubleshooting skills are essential.

Responsibilities

• Oversee GMP cell therapy manufacturing processes and troubleshoot issues.
• Ensure compliance with safety, GMP, SOPs, and GDPs.

Skills

GMP biopharmaceutical manufacturing

Aseptic technique

Leadership

Troubleshooting

Communication

Microsoft Office

Education

Bachelor's degree or relevant experience

Tools

Microsoft Office

Job description

Lead Aseptic Manufacturing Technician - Night Shift

Join to apply for the Lead Aseptic Manufacturing Technician - Night Shift role at Iovance Biotherapeutics, Inc.

Overview

Iovance Biotherapeutics is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL).

The Lead Aseptic Manufacturing Technician role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes.

Responsibilities

• Oversee and execute GMP cell therapy manufacturing processes, troubleshoot issues, and serve as SME for aseptic techniques.
• Ensure strict adherence to aseptic procedures within cleanroom environments, including BSC manipulations, liquid transfers, and in-process sampling.
• Lead and train team members, ensuring compliance with safety, GMP, SOPs, and GDPs.
• Maintain accurate documentation, review batch records, and manage inventory and room readiness.
• Participate in shift operations, including overtime, weekends, and holidays as required.

Qualifications

• Bachelor's degree or relevant experience.
• Minimum 3+ years in GMP biopharmaceutical manufacturing, with aseptic technique expertise.
• Strong leadership, troubleshooting, and communication skills.
• Proficiency in Microsoft Office and understanding of GxP regulations.

Physical & Work Environment

Must be able to wear PPE, work in cleanroom conditions, lift up to 50 lbs, and pass vision exams. Work may include exposure to biohazards, chemicals, noise, and odors.

Additional Information

This role involves working in both office and manufacturing settings, requiring adaptability and commitment to safety and quality standards. Iovance promotes diversity and provides accommodations upon request.