Production Associate Dermagraft

Role Summary

Production Associate Dermagraft - This entry level position involves performing aseptic processing of Dermagraft under supervision, supporting manufacturing to ensure safe and timely production in ISO 7 and ISO 8 cleanrooms. Typical hours are Monday–Friday, 7:30 am – 4:00 pm.

Responsibilities

• Responsible for aseptically manufacturing Dermagraft according to established Master Batch Records and Operating Procedures, including seeding cells, media changes, harvesting of final product and packaging for commercial distribution.
• Prepare all media and sanitizing agents used in Production areas and prep materials for autoclaving.
• Adhere to all Operating Procedures, protocols, regulatory requirements, cGMP, and safety guidelines.
• Ensure batch records are complete and compliant with all protocols.
• Operate clean room equipment properly.
• Maintain required records and adhere to guidelines for quality control, cGMPs, and safety.

Qualifications

• Associates or Bachelor’s degree in biology or related science and/or 0–2 years experience; experience in aseptic technique, cGMP and clean room protocols desired.
• Certificate in Biotechnology and/or 1–2 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 as part of a team and independently as required.
• Ability to perform calculations using weight, volume, and distance per Quality documents and SOPs.
• Extensive knowledge of GMPs for cellular-based products; effective communication with internal and external groups.
• Overtime, weekend, and holiday work may be required based on company needs.

Skills

• Aseptic technique, clean room gowning
• Good Manufacturing Practices (GMPs) for cellular-based products
• Communication and collaboration across manufacturing teams

Education

• Associates or Bachelor’s degree in biology or related science; or Certificate in Biotechnology

Additional Requirements

• Physical ability to work in a cleanroom environment fully gowned for extended periods; ability to push 150+ lbs and lift 50 lbs; must work with living human cells and chemicals; pre-employment physical and lift test required.