Production Associate Dermagraft

Organogenesis Inc.; Smithfield (RI); On-site; Full time

Job summary

A leading regenerative medicine company is seeking a Dermagraft Associate to perform aseptic processing in cleanroom environments. This entry-level position offers opportunities for growth and development while ensuring the safe production of vital wound care products. Ideal candidates will have a degree in biology or related fields and experience in aseptic techniques.

Benefits

401k with employer match

Comprehensive medical, dental, and vision coverage

Education assistance policy - $5,000 per year

Generous paid time off including vacation and holidays

Qualifications

• 0-2 years experience in aseptic techniques and cGMP.
• Knowledge of Quality Systems regulations preferred.
• Ability to perform calculations with weight, volume, and distance.

Responsibilities

• Manufacturing Dermagraft under strict aseptic conditions.
• Preparing media and sanitizing agents; autoclaving materials.
• Maintaining accurate records compliant with quality standards.

Skills

Aseptic Technique

Cleanroom Protocol

Basic Laboratory Techniques

Education

Associates or Bachelor’s degree in biology or related science

Certificate in Biotechnology

Job description

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 byEmpowering 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 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.

Requirements

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

The anticipated annualized base salary for this role is$24.00per hour and reflects current market data for similarly-sized life science companies and internal equity. Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law.

We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law.

We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes.