Manufacturing Associate I/II
Location: San Diego, CA
SHIFT: SUNDAY - THURSDAY, 6:00 AM - 2:30 PM.
The Manufacturing Associate I/II is responsible for completing and assisting with daily tasks associated with cell-related functions, including producing cells, intermediate product, and manufacturing final product for commercial distribution. Additionally, the Associate I/II will be responsible for following SOPs, performing daily tasks in a clean room/cGMP environment. The Manufacturing Associate I/II may also be responsible for the troubleshooting of manufacturing challenges. Follows established company rules, regulations and safety precautions, and maintains quality standards.
- Perform responsibilities that include various duties that are required to produce cell based product. Some of these duties include: cell expansion, cell feeding, harvesting, counting and freezing; product seeding, labeling, intermediate formulations, and operation of robotic cell culturing system.
- MFG Associate I/II must be familiar with documentation for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and clean room safety practices and procedures.
- Performs production related tasks as assigned by the Area Supervisor or Group Lead. These tasks can include, but are not limited to, Quality Event Notifications, Facilities Maintenance Requests, ordering of supplies, materials, and equipment for production.
- Assist with providing training for new and existing employees on the Upstream Manufacturing process.
- Assist in providing positive and constructive individual feedback and building teamwork.
PREFERRED EDUCATION AND EXPERIENCE:
The Manufacturing Associate I/II will have a minimum of 2 years’ prior working experience with cell culture in a manufacturing (Biotech/Pharmaceutical Industry) environment with Associate’s degree in related area and/or a Biotech Program certificate from an accredited college.
- Must have hands-on-experience with commonly used production concepts, practices, and procedures such as cell culture and aseptic technique.
- General knowledge of clean room practices and familiarity with Current Good Manufacturing Practices (cGMP).
- Must be detail-oriented with an ability to set priorities, and organize daily work requirements. The Manufacturing Associate I/II must be able to work as a team member and independently as required.
- Ability to perform calculations using weight measurement, volume, and distance governed by Quality documents and Standard Operating Procedures.
- Experience in writing and/or revising Standard Operating Procedures (SOPs), Batch Records, and other Quality/Compliance related documents.
- Aseptic technique, clean room gowning and extensive knowledge of Good Manufacturing Practices (GMPs), with an emphasis on Biologics.
- Effectively communicate with internal and external group members by collaborating with sub-teams within manufacturing and across Organogenesis.
- Working in a clean room environment required. Must clothe in clean room gowns to perform duties.
- Effective communication and listening skills are required.
- Must work with living human cells and various chemicals.
- Must be able to push 150+ lbs. (on wheels), and lift 50lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Due to the nature of production work, overtime and weekend work is a requirement of employment and is variable based on company needs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.