Production Associate Dermagraft

About Us

We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing.

Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our strength is giving others strength.

What You Will Achieve:

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 clean rooms.

The hours for this position are Monday-Friday-7:30 am
-4:00 pm

How You Will Achieve It:

• 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.

What You Need to Achieve It:

• 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.

Physical Requirements:

• Ability to work in a cleanroom environment, fully gowned, for extended periods of time
• Dexterity, coordination and must be able to push 150+ lbs. (on wheels), and lift 50lbs.
• Must work with living human cells and various chemicals.
• Pre-employment physical and lift test required,

What can we offer you?

• 401k -- generous employer match with immediate vesting and financial planning resources
• Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
• Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
• Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
• Paid maternity leave and parental leave for all new parents
• Adoption benefits
• Education Assistance Policy - $5,000 per year for all employees
• Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
• Employee Assistance Program
• Generous paid time off including vacation, floating…