Work Location: Montgomery County, Pennsylvania

Summary:

The Bioprocess Technician I is responsible for hands-on clinical manufacturing of cell therapy products in compliance with current Good Manufacturing Practices (cGMPs) and established procedures. This role involves working collaboratively with a team of technicians, specialists, and scientists to support cell therapy manufacturing and process development activities.

Responsibilities:

• Execute hands-on manufacturing of cell therapy products using advanced cell manufacturing technologies, including media preparation, cell culture maintenance, sampling, and cell counting.
• Follow and accurately complete batch records and standard operating procedures to ensure compliance and product quality.
• Perform aseptic and closed manipulations within Biosafety Cabinets and various cleanroom environments (Grade B, C, and D).
• Carry out manufacturing process steps in accordance with cGMP, internal procedures, and applicable regulations.
• Complete assigned work tasks efficiently and thoroughly, supporting overall manufacturing timelines.
• Assist with process development, manufacturing sciences, and cross-functional support as needed.
• Author and maintain controlled documents, including SOPs, forms, and batch records, ensuring documentation accuracy.
• Support deviation investigations, implement corrective and preventive actions (CAPAs), and participate in qualification and validation activities.

Qualifications:

• Bachelor’s degree (science preferred) with 0-2 years of relevant or equivalent experience.
• Excellent oral and written communication skills.
• Strong organizational skills with the ability to present results clearly, work collaboratively in a team, and operate independently.
• Attention to detail and ability to follow written procedures accurately.
• Demonstrated ability to work in a dynamic, fast-paced environment and meet deadlines.
• Reliable, adaptable, and eager to learn new skills.
• Ability to work in environments with biohazards and chemicals, and wear appropriate cleanroom attire and PPE.
• Capable of working in settings with variable noise levels, standing/sitting/walking for extended periods, and routinely lifting/pushing/pulling up to 40 lbs.

Published Category: Manufacturing & Technical Operations