Quick Info
Salary Range
$24 - $24
Job Type
Full TimeSpecialty Skills
cGMPAseptic TechniqueCleanroom ProtocolsBiotechnology
About the Role
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
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 holidays, sick days, and company holidays
* Free parking including an electric charging station (Canton and La Jolla)
* Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint