Manufacturing Associate (I/II/III)

Global Life Science Hub is partnered with an incredible biopharmaceutical company specializing in difficult-to-formulate biologics. Recently, the company has achieved 2 FDA approvals and is transitioning from R&D to a full-scale commercial organization looking to build a new state-of-the-art facility as they triple their production output into 2025

We are currently seeking 5x highly motivated Manufacturing Associates (Levels I, II, and III) to join the Drug Product Team , focused on theaseptic filling and packaging of biologic products . In this role, you will work in a controlled environment, supporting critical manufacturing activities from the preparation of materials to the final packaging of sterile drug products.

Manufacturing Associate I

• Assist in routine aseptic operations, including filling and packaging of biologic drug products in a cleanroom environment.
• Support setup and cleaning of manufacturing equipment and areas in compliance with GMP (Good Manufacturing Practices).
• Monitor and document activities following SOPs (Standard Operating Procedures).
• Perform routine visual inspections for quality assurance during the packaging process.
• Collaborate with cross-functional teams to meet production schedules.
• Adhere to strict safety and hygiene protocols to maintain a sterile environment.

Manufacturing Associate II

• Execute and monitor aseptic filling, labeling, and packaging operations with minimal supervision.
• Lead or participate in equipment setup, troubleshooting, and minor maintenance activities.
• Ensure accuracy and completeness of batch records, and review documentation for compliance with regulatory standards.
• Identify process improvements to enhance efficiency and ensure product quality.
• Train and mentor junior associates in aseptic techniques and procedures.
• Contribute to problem-solving efforts related to operational challenges and ensure timely reporting of deviations.

Manufacturing Associate III

• Lead aseptic filling and packaging operations, ensuring adherence to strict cGMP and regulatory standards.
• Oversee the performance of equipment and personnel to ensure smooth operations and compliance with safety protocols.
• Collaborate with engineering, quality, and other departments to resolve complex technical and operational issues.
• Drive continuous improvement initiatives to optimize processes and improve throughput.
• Perform batch record review and ensure adherence to documentation requirements.
• Train, mentor, and lead team members to ensure competency and compliance with aseptic and GMP standards.
• Play a key role in supporting validation activities and audits.

Manufacturing Associate I

• High school diploma or equivalent; Associate degree in a relevant field preferred.
• 0-1 year of experience in a GMP or cleanroom manufacturing environment (experience in biologics or pharmaceuticals is a plus).
• Understanding of aseptic techniques and sterile operations is an advantage.
• Ability to follow detailed instructions and documentation practices.

Manufacturing Associate II

• High school diploma or equivalent; Associate or Bachelor's degree in life sciences or engineering preferred.
• 1-3 years of experience in a GMP-compliant aseptic manufacturing or filling environment.
• Strong understanding of sterile processing, aseptic techniques, and cGMP regulations.
• Proficiency in the use of aseptic filling and packaging equipment.
• Ability to work independently with minimal supervision.

Manufacturing Associate III

• Bachelor's degree in life sciences, engineering, or a related field preferred.
• 3+ years of experience in aseptic manufacturing, filling, or packaging, with a focus on biologic drug products.
• Expertise in GMP regulations, aseptic techniques, and sterile operations.
• Proven leadership experience in a manufacturing or production environment.
• Strong problem-solving skills, with the ability to troubleshoot complex issues in aseptic processing.

Apply:

Global Life Science Hub is a specialized Life Science headhunting firm. We place professionals across Europe and the US for various Biotechnology, Pharmaceutical, and CDMO companies, ranging from small start-ups to large global organizations.

If you're interested, please apply below. If this position doesn?t suit you, visit our website for more vacancieswww.glshub.com