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 Services Associate I to manufacture cellular products. This full-time on-site role involves working in a laboratory setting, adhering to quality standards, and contributing to process improvements. The ideal candidate will have a degree in Life Sciences or Engineering and relevant experience in biologics or biopharmaceutical manufacturing.

Qualifications

• 6+ years relevant laboratory/manufacturing experience.
• Minimum of 6 years’ experience in biologics, medical device, or biopharmaceutical manufacturing.

Responsibilities

• Manufacture cellular products adhering to quality and safety standards.
• Prepare media and maintain cell cultures under sterile conditions.
• Document and review batch records and quality system records.

Skills

Communication

Teamwork

Education

Undergraduate degree in Life Sciences or Engineering

Job description

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 muscle-related disorders. We have the potential to make a difference in the lives of many people worldwide and in yours. Joining our team offers 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.

Position Summary

The Laboratory Research Services Associate I is responsible for manufacturing cellular products that meet company Quality System standards, SOPs, and regulatory requirements.

Responsibilities

1. Perform daily work adhering to cGMPs, Quality System, and safety standards.
2. Prepare media, bulk solutions, and perform filling and labeling of vials under sterile conditions.
3. Dissociate human tissue to establish cell cultures.
4. Maintain routine cell cultures (media changes and passages).
5. Harvest, formulate, and fill terminal cell cultures for release.
6. Collect and submit product and environmental monitoring samples.
7. Assist in manufacturing non-GMP Research Use Only (RUO) products and services.
8. Document and review batch records and associated forms promptly.
9. Initiate and author quality system records (e.g., investigations).
10. Operate routine laboratory equipment (incubators, centrifuges, balances, BSHs, freezers, liquid nitrogen storage).
11. Troubleshoot issues and escalate investigations as needed.
12. Perform cell count and viability assays using flow cytometry.
13. Monitor products daily, manually and via automated systems.
14. Manage quarantine and storage of manufactured products.
15. Assist with routine lab cleaning and sanitization.
16. Manage inventory and ordering to ensure resource availability.
17. Dispose of biohazard waste properly.
18. Prepare work areas and perform changeovers for product interventions and lot clearance.
19. Contribute to process improvements and optimization.

Core Values and Expectations

Exemplify Cook MyoSite Core Values. Maintain punctuality, quality, and safety standards. Commit to ongoing learning and skill development. Work effectively both independently and collaboratively. Maintain professionalism and flexibility in stressful situations. Interact professionally across all organizational levels. Demonstrate trainability and effective communication skills. Prioritize tasks proactively. This position is full-time and on-site.

Qualifications

• Undergraduate degree in Life Sciences or Engineering, or 6+ years relevant laboratory/manufacturing experience.
• Minimum of 6 years’ experience in biologics, medical device, or biopharmaceutical manufacturing.

Physical Requirements

• Work in a laboratory setting with potential exposure to hazardous chemicals.
• Ability to communicate effectively and work extended hours, including evenings and weekends.
• Prolonged sitting and standing; visual acuity; manual dexterity.
• Ability to lift up to 50 pounds occasionally.

Additional Policies

Adhere to all company policies, including the Employee Manual, Code of Conduct, Quality System Manual, Electronic Information Policy, and HIPAA regulations. We celebrate diversity and are an equal-opportunity employer.

This job description outlines essential functions but is not exhaustive and may change as needed.