Production Associate Dermagraft

Role Summary

This is an entry level position. The Associate will perform all activities involved in the aseptic processing of a living product (Dermagraft), under the direct supervision of the Dermagraft Team Leader/Dermagraft Supervisor/Manager. The Dermagraft Associate will support the Dermagraft Manufacturing department by performing the tasks that will assure the safe and timely processing of Dermagraft, working in both a ISO 7 and ISO 8 cleanrooms. The hours for this position are Monday-Friday-7:30 am -4:00 pm.

Responsibilities

• Responsible for aseptically manufacturing Dermagraft according to established Master Batch Records and Operating Procedures associated with cell-growth functions, including seeding cells, media changes, and harvesting of final product and packaging for commercial distribution.
• Responsible for the preparation of all media and sanitizing agents used in the Production areas as well as prepping materials for autoclaving and autoclaving the materials.
• Responsible for adherence to all Operating Procedures, protocols, policies, regulatory requirements, cGMP, and safety guidelines.
• Responsible for assuring batch records are complete and are compliant with all protocols.
• Responsible for proper operation of all clean room equipment.
• Responsible for maintaining all required records and adherence to established guidelines for quality control procedures, cGMP’s, and safety.

Qualifications

• Required: 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.
• Preferred: Certificate in Biotechnology and/or a minimum of 1 - 2 years relevant experience.
• Required: Quality Systems regulations (cGMP) knowledge and clean room experience.
• Required: Aseptic Technique and cleanroom protocol experience; Basic knowledge of laboratory techniques.
• Required: Ability to work as a team member and independently as required; ability to perform calculations using weight measurement, volume, and distance governed by Quality documents and SOPs.
• Required: Aseptic technique, clean room gowning and extensive knowledge of GMPs, with emphasis on cellular based products; effective communication with internal and external group members.
• Required: Willingness to overtime, weekends, and holidays as needed based on company needs.

Skills

• Strong collaboration and communication across manufacturing sub-teams and with Organogenesis.
• Proficiency in calculations and basic laboratory techniques.
• Understanding of GMP, aseptic technique, and clean room protocols.

Education

• Associates or Bachelor’s degree in biology or related science (required).
• Certificate in Biotechnology (preferred).

Additional Requirements

• Physical ability to work in a cleanroom environment in full gowning for extended periods; must be able to push 150+ lbs. on wheels and lift 50 lbs.
• Must work with living human cells and various chemicals; pre-employment physical and lift test required.