Aseptic Manufacturing Technician II (Night Shift)

ZipRecruiter; Philadelphia (Philadelphia County); On-site; USD 50,000 - 90,000; Full time

Job summary

An established industry player is seeking an Aseptic Manufacturing Technician II to join their innovative autologous cell therapy program. This role is vital for ensuring the quality and efficiency of manufacturing processes, requiring a strong foundation in cell culture and aseptic techniques. The ideal candidate will thrive in a dynamic environment, showcasing a proactive approach and a commitment to quality standards. Join a team dedicated to advancing biopharmaceutical solutions and make a meaningful impact in the field of cell therapy.

Qualifications

• 1-2 years in GMP manufacturing with a focus on cell culture and downstream processing.
• Familiarity with FDA regulations and GxP best practices.

Responsibilities

• Responsible for cleaning, sanitization, and preparation of products.
• Support manufacturing processes in a complex environment.

Skills

Cell Culture

Aseptic Gowning

GMP Manufacturing

Quality Mindset

Proactive Attitude

Education

1-2 years experience in biopharmaceutical manufacturing

Job description

The Aseptic Manufacturing Technician II 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. The Manufacturing Technician will be responsible for various tasks, such as cleaning, sanitization, preparation, and fulfilling products for commercial and clinical use. To excel in this role, it is strongly desired that the candidate has a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations.

Education, Skills, and Knowledge

• Minimum 1-2 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Proactive, results-oriented, self-starter with experience in a complex manufacturing environment.