Production Associate Dermagraft

Role Summary

Entry-level Production Associate Dermagraft in regenerative medicine manufacturing, performing aseptic processing of a living product under the direct supervision of the Dermagraft Team Leader/Supervisor/Manager. The role supports the Dermagraft Manufacturing department to ensure safe and timely processing in ISO 7 and ISO 8 cleanrooms. Hours are Monday–Friday, 7:30 am–4:00 pm.

Responsibilities

• Manufacture Dermagraft aseptically according to Master Batch Records and Operating Procedures for cell-growth functions, 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 and autoclaving the materials.
• Adhere to all Operating Procedures, protocols, policies, regulatory requirements, cGMP, and safety guidelines.
• Ensure batch records are complete and compliant with all protocols.
• Operate clean room equipment properly.
• Maintain all required records and adhere to quality control procedures, cGMPs, and safety guidelines.

Qualifications

• Required: Associates or Bachelor's degree in biology or related science and/or 0–2 years of experience.
• Preferred: Experience in aseptic technique, cGMP and clean room protocols.
• Preferred: Certificate in Biotechnology and/or 1–2 years of relevant experience.
• Preferred: Knowledge of cGMP and clean room experience.
• Required: Aseptic technique and cleanroom protocol experience.
• Required: Basic knowledge of laboratory techniques.
• Required: Ability to work as a team member and independently as required.
• Required: Ability to perform calculations using weight, volume, and distance governed by quality documents and standard operating procedures.
• Required: Aseptic technique, clean room gowning and extensive knowledge of GMPs, with an emphasis on cellular-based products.
• Required: Effective communication with internal and external group members by collaborating with sub-teams within manufacturing and across the organization.
• Required: Overtime, weekend and holiday work may be required based on company needs.

Education

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

Additional Requirements

• Ability to work in a cleanroom environment, fully gowned, for extended periods
• Dexterity, coordination and ability 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
• Overtime and weekend/holiday work may be required based on company needs