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

• 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 a minimum of 1 - 2 years relevant experience.
• Quality Systems regulations (cGMP) knowledge and clean room experience preferred but not required.
• Aseptic Technique and cleanroom protocol experience
• Basic knowledge of laboratory techniques
• Must be able 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 Standard Operating Procedures.
• Aseptic technique, clean room gowning and extensive knowledge of Good Manufacturing Practices (GMPs), with an emphasis on cellular based Products.
• Effectively communicate with internal and external group members by collaborating with sub-teams within manufacturing and across Organogenesis.
• Due to the nature of production work, overtime and weekend work as well as Holiday work is a requirement of employment and is variable based on company needs.

Skills

• Aseptic technique
• Clean room protocols
• Good Manufacturing Practices (GMPs)
• Cell-growth and aseptic processing knowledge
• Communication and collaboration across teams

Education

• Associates or Bachelor’s degree in biology or related science (or equivalent experience)

Additional Requirements

• Physical requirements: ability to work in a cleanroom environment, fully gowned, for extended periods; 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.