Production Associate Dermagraft

Role Summary

Production Associate Dermagraft – entry level position performing aseptic processing of Dermagraft in ISO 7 and ISO 8 cleanrooms under supervision.

Responsibilities

• Manufacture Dermagraft aseptically according to Master Batch Records and Operating Procedures, including seeding cells, media changes, harvesting, and packaging for distribution.
• Prepare media and sanitizing agents and prep materials for autoclaving.
• Adhere to all procedures, protocols, regulatory requirements, cGMP, and safety guidelines.
• Ensure batch records are complete and compliant with protocols.
• Operate clean room equipment properly.
• Maintain records and follow quality control, cGMP, and safety guidelines.

Qualifications

• Associates or Bachelor‚Äôs degree in biology or related science and/or 0‚Äì2 years experience; experience in aseptic technique, cGMP, and clean room protocols desired.
• Certificate in Biotechnology and/or 1‚Äì2 years relevant experience.
• Knowledge of Quality Systems regulations (cGMP) and clean room experience preferred but not required.
• Aseptic technique and cleanroom protocol experience.
• Basic knowledge of laboratory techniques.
• Ability to work in a team and independently as required.
• Ability to perform calculations using weight, volume, and distance per quality documents and SOPs.
• GMPs knowledge with emphasis on cellular-based products; strong communication with internal/external groups.
• Overtime, weekend, and holiday work may be required based on company needs.

Skills

• Aseptic technique; clean room gowning; GMP knowledge.
• Effective collaboration and communication across manufacturing teams.

Education

• Associates or Bachelor‚Äôs degree in biology or related science.

Physical Requirements

• Ability to work in a cleanroom environment fully gowned for extended periods.
• Dexterity; able to push 150+ lbs and lift 50 lbs.
• Must work with living human cells and various chemicals.
• Pre-employment physical and lift test required.