Production Associate I - Apligraf

Organogenesis Inc.; Canton, Northern (MA, KY); Hybrid; USD 33,000 - 34,000; Full time

Benefits offered by this job

401k

Medical, Dental, Vision

Flexible Spending Account

Paid maternity/parental leave

Education assistance

Wellness program

Paid time off

Free parking with EV charging

Job summary

Organogenesis Inc. is seeking an entry level Apligraf Associate I to perform aseptic processing of Apligraf under supervision. Work in Class 100 and 10K cleanrooms with hours Monday–Friday 7:30 am–4:00 pm, some holidays required.

Responsibilities include manufacturing per Master Batch Records, preparing media, and maintaining records. The role requires biotechnology certification or 1–2 years of related experience, and knowledge of cGMP with clean room experience preferred.

Qualifications

• Certificate in Biotechnology and/or 1–2 years relevant experience.
• Associates or Bachelor’s degree in biology or related science.
• cGMP knowledge and clean room experience preferred but not required.
• Experience in aseptic technique, GMP and clean room protocols desired.

Responsibilities

• Manufacture Apligraf according to established Master Batch Records and Operating Procedures.
• Prepare all media and sanitizing agents used in Production areas.
• Adhere to all Operating Procedures, protocols, policies, regulatory requirements, GMP, and safety guidelines.
• Ensure batch records are complete and compliant with all protocols.
• Properly operate all clean room equipment.
• Maintain records and adhere to quality control procedures, GMPs, and safety guidelines.

Education

Associates or Bachelor's degree in Biology or related science

Tools

Aseptic technique

C GMP knowledge

Clean room experience

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.

Learn more about Careers at Organogenesis

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 (Apligraf), under the direct supervision of the Apligraf Team Leader/Apligraf Supervisor/Manager. The Apligraf Associate I will support the Apligraf Manufacturing department by performing the tasks that will assure the safe and timely processing of Apligraf, working in both a Class 100 and Class 10K cleanroom.

The hours for this position are Monday-Friday 7:30 am-4:00 pm, some holidays required.

How You Will Achieve It:

• Responsible for manufacturing Apligraf according to established Master Batch Records and Operating Procedures.
• Responsible for the preparation of all media and sanitizing agents used in the Production areas.
• Responsible for adherence to all Operating Procedures, protocols, policies, regulatory requirements, GMP, 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, GMP’s, and safety.

Requirements

What You Need to Achieve It:

• Certificate in Biotechnology and/or a minimum of 1 - 2 years relevant experience
• Associates or Bachelor’s degree in biology or related science and/or 0 - 2 years experience preferred
• Quality Systems regulations (cGMP) knowledge and clean room experience preferred but not required
• Experience in aseptic technique, GMP and clean room protocols desired.
• Basic knowledge of lab techniques
• Ability to work in a cleanroom environment, for extend periods of time.
• Dexterity, coordination and some lifting required

Physical Requirements:

• Medium work, occasionally lifting objects up to 40 lbs.
• Standing up to 6.5 hours/day.
• A pre-employment physical and lift test is required for this position

• Ability to work in a cleanroom environment, for extend periods of time.
• Dexterity, coordination and some lifting 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 hourly rate for this role is$24.04 - $24.04 per 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.