We are currently seeking 5x highly motivated Manufacturing Associates (Levels I, II, and III) to join our Drug Product Team, focused on the aseptic 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.
Experience/Qualifications:
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.
