Aseptic Manufacturing Technician II

Aseptic Manufacturing Technician

Philadelphia, PA (Onsite)

6-Month Contract-to-Hire

**Day & Night Shifts Avaliable - 12 hour shifts

Sunday to Wednesday OR Wednesday to Saturday**

Compensation:

• AMT II: $31.75/hr
• Sr. AMT: $35/hr
• Lead AMT: $40/hr

MUST HAVE EXPERIENCE: 1 year - Aseptic Technique, GMP, Gowning, Cell Culture/Cell Processing

About:

At the forefront of cutting-edge biotechnology, our organization is dedicated to advancing innovative solutions in the autologous cell therapy space. We’re looking for passionate, detail-oriented professionals to join our team and play a pivotal role in our mission to transform lives through groundbreaking treatments.

Why This Role?

As an Aseptic Manufacturing Technician, you will be at the heart of our manufacturing process, contributing to the development and production of life-changing cell therapies. You will apply your expertise in aseptic techniques, cell culture, and GMP practices in a fast-paced, dynamic environment.

This is an exceptional opportunity to build your career within a growing industry while making a direct impact on cutting-edge medical solutions.

Your Responsibilities:

• Master GMP and Cell Therapy Processes: Develop a comprehensive understanding of Good Manufacturing Practices (GMP) and cell therapy manufacturing processes. Ensure all operations meet strict quality and regulatory standards.
• Support Key Operations: Manage essential tasks, including cleaning, sanitization, room readiness, materials handling, and equipment maintenance to support both commercial and clinical production.
• Document with Precision: Conduct batch record reviews, logbooks, SOP revisions, and other documentation activities to ensure compliance with regulatory requirements.
• Training & Mentoring: Guide and mentor new team members on best practices and aseptic techniques. Provide training support while helping to identify areas for continuous improvement.
• Collaborate Across Teams: Work closely with cross-functional teams on various assignments, contribute to research activities, and assist in technical transfers.
• Adhere to High Standards: Comply with all safety protocols, SOPs, and Good Documentation Practices (GDP), while maintaining a proactive mindset to prevent and resolve potential issues.

What You Need to Succeed:

• Education: Bachelor’s degree (or equivalent post-secondary education) in a relevant field.
• Required Skills and Knowledge:
• Proven experience in aseptic processing within cleanroom environments.
• Strong background in cell culture, aseptic gowning, and GMP compliance.
• Detail-oriented with a keen understanding of documentation practices and FDA regulations (21 CFR Part 11).
• Ability to adapt quickly in a changing environment and work independently or as part of a team.
• Preferred Experience:
• 1 years of experience in biopharmaceutical manufacturing, particularly in cell culture and downstream processing.
• Familiarity with GxP best practices and FDA regulations.
• Physical and Mental Requirements:
• Ability to stand, walk, and lift up to 45 pounds during your shift.
• Capable of working in a cleanroom environment with biohazards and chemicals.
• Clear judgment and problem-solving skills, with the ability to handle multiple priorities and meet deadlines.

Why You’ll Love Working Here:

• Impactful Work: Be part of a team that’s advancing life-saving therapies and making a tangible difference in patient outcomes.
• Competitive Pay: With attractive hourly rates based on your level of experience, we reward your hard work and dedication.
• Dynamic Environment: Work across various shifts (including weekends and holidays), gaining exposure to a wide range of challenges and opportunities for growth.
• Supportive Culture: Join a diverse and inclusive team that values innovation, collaboration, and your unique contributions.

Ready to Make an Impact?

If you're passionate about improving lives through biotechnology and want to be a part of a dedicated, high-performance team, apply now to start your next career chapter!

Note: The physical and mental demands outlined here represent the essential functions of the role. Reasonable accommodations may be made upon request. Please contact Human Resources for assistance.