Senior Manufacturing Associate

Senior Manufacturing Associate

We are seeking an experienced Senior Manufacturing Associate to join a clinical manufacturing team supporting the production of advanced cell therapy products. This role is ideal for candidates with experience in cGMP manufacturing, aseptic processing, and cleanroom operations who are passionate about contributing to life-changing therapies.

Key Responsibilities

• Perform clinical manufacturing activities for cell therapy products in accordance with cGMP standards.
• Execute manufacturing processes by following Standard Operating Procedures (SOPs), maintaining aseptic technique, and completing accurate batch documentation.
• Assemble and prepare raw materials for manufacturing operations.
• Transfer materials into cleanroom environments using approved sanitization procedures.
• Identify, document, and report manufacturing deviations.
• Demonstrate and support best practices in aseptic processing.
• Participate in process transfers from Development to Manufacturing as needed.
• Assist with the development and revision of manufacturing documentation and SOPs.
• Coordinate with cross-functional teams to ensure materials and resources are available for production.
• Maintain compliance with quality standards, safety requirements, and GMP regulations.
• Support continuous improvement initiatives and other departmental projects as assigned.

Qualifications

• Experience in biopharmaceutical, biotechnology, cell therapy, or other GMP-regulated manufacturing environments.
• Strong knowledge of cGMP regulations and Good Documentation Practices (GDP).
• Hands-on experience with aseptic techniques and cleanroom operations.
• Ability to accurately complete manufacturing documentation and batch records.
• Strong attention to detail, organizational skills, and communication abilities.
• Experience collaborating with Manufacturing, Quality, and Process Development teams is preferred.

Physical Requirements

• Ability to work in both cleanroom and office environments.
• Remain stationary for extended periods during manufacturing activities.
• Frequently move throughout the cleanroom while performing production tasks.
• Lift and move materials or equipment weighing up to 50 pounds.
• Safely work with compressed gases and liquid nitrogen (LN?).