Laboratory Research Associate I

Cook Medical; Pittsburgh (Allegheny County); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading company in regenerative medicine is seeking a Laboratory Research Associate I. This full-time, on-site role involves performing cell culture, adhering to safety standards, and contributing to process improvements. Ideal candidates will have a degree in Life Sciences or Engineering and relevant experience in biologics or medical device manufacturing. Join a passionate team dedicated to making a difference in healthcare.

Qualifications

• Minimum of 6 years' experience in biologics, medical device, or biopharmaceutical manufacturing.

Responsibilities

• Perform daily work with strict adherence to cGMPs and safety standards.
• Document and review required information in Production batch records.
• Assist with routine cleaning and sanitization of laboratories.

Skills

Communication

Problem Solving

Teamwork

Education

Undergraduate degree in Life Sciences or Engineering

Tools

Microsoft Office

Job description

Join to apply for the Laboratory Research Associate I role at Cook Medical

Overview
Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

Responsibilities

1. Perform daily work with strict adherence to cGMPs, the company Quality System, and safety standards
2. Perform preparation of media, bulk solutions, filling and labeling of vials under sterile conditions
3. Perform dissociation of human tissue to establish cell cultures
4. Perform routine cell culture maintenance (media changes and passages)
5. Perform terminal cell culture harvesting, formulation, and filling for releasable products
6. Perform collection and submission of product generated and environmental monitoring samples
7. Perform and/or assist in the manufacture of non-GMP Research Use Only (RUO) products and services
8. Document and review required information in Production batch records and associated forms in a timely fashion
9. Initiate and author quality system records (i.e., investigations)
10. Operate routine laboratory equipment, including incubators, centrifuges, balances, BSHs, freezers, and liquid nitrogen storage units
11. Perform troubleshooting and bring potential investigations to the Manager’s attention
12. Perform established cell count and viability assays using a flow cytometer
13. Monitor products daily, manually and using automated systems
14. Handle quarantine and storage of manufactured products
15. Assist with routine cleaning and sanitization of laboratories and equipment
16. Assist with inventory management and ordering of resources
17. Properly dispose of biohazard waste
18. Prepare and change over processing areas for interventions and lot clearance
19. Assist in process improvements and optimization
20. Exemplify Cook MyoSite Core Values
21. Maintain punctuality and adherence to safety and quality standards
22. Commit to ongoing training and skill development
23. Work effectively in collaborative and independent environments
24. Maintain professionalism and effective communication skills
25. Prioritize tasks and operate proactively

Qualifications

• Undergraduate degree in Life Sciences or Engineering, or 6 years relevant experience
• Minimum of 6 years' experience in biologics, medical device, or biopharmaceutical manufacturing

Physical Requirements

• Work in laboratory and production settings with potential exposure to hazardous chemicals
• Ability to work extended hours, including evenings and weekends
• Visual acuity and color discrimination capabilities
• Ability to lift up to 50 pounds occasionally
• Ability to work in various physical positions for extended periods

Additional requirements include compliance with company policies, ability to work under stress, and effective communication skills. The position is full-time, on-site, and requires proficiency in Microsoft Office and understanding of cGMP and related regulations.