Associate Scientist / Manufacturing Engineer (cGMP)

Our client is a growing regenerative medicine company with an impressive pipeline spanning preclinical through commercial products!

We are seeking a Manufacturing Engineer with cGMP experience to join our team in advancing the production of clinical-grade cell-based therapeutics. This is an exciting opportunity to contribute directly to life-changing therapies and cutting-edge research!

Key Responsibilities:

• Maintain and differentiate adult human stem cell culture in a cGMP environment 
• Ensure timely delivery of high-quality clinical products
• Oversee project planning, budgeting, and timelines 
• Collaborate across R&D, process development, facilities, and quality teams to drive projects from concept to completion
• Evaluate and improve manufacturing workflows
• Support process transfers, validation of new products, and troubleshooting
• Identify opportunities to enhance efficiency, product quality, and yields
• Prepare technical reports, design specifications, and protocols compliant with cGMP standards and the company’s quality management system.

Core Qualifications:

• Bachelor’s in Biology or related field, Master's preferred
• 2+ years of related industry experience
• Hands-on experience working under cGMP in regulated environments (e.g., 21 CFR parts 210, 211, or 820).
• Strong knowledge of pharmaceutical manufacturing, aseptic techniques, facilities, utilities, equipment qualification, and process validation.
• Demonstrated experience with workflow optimization and continuous process improvement.

Why Join Us:

Be part of a team driving the next generation of cell-based therapeutics! You’ll work in a dynamic environment where innovation, collaboration, and scientific excellence are at the heart of everything we do.