Manufacturing Associate III, Downstream

Your Role

Join our team as a Manufacturing Associate III - Downstream and be at the forefront of biopharmaceutical innovation. In this pivotal role, you'll drive the production of life-changing therapies in our state-of-the-art viral vector facility, utilizing your expertise in GMP and biologics manufacturing. With a focus on executing complex virus purification and filtration, you'll not only ensure the delivery of high-quality products but also mentor the next generation of scientists.

Key Responsibilities

• Support in prioritizing manufacturing schedule requirements and responsible for executing the daily manufacturing schedule within a fast-paced manufacturing operation with primary activities of virus purification techniques including but not limited to Harvest, Clarification, Purification Techniques (TFF and Chromatography), Various Filtration Techniques, and Product Filling.
• Troubleshoot equipment and processes in partnership with Manufacturing Science and Technology department.
• Conduct analytical tests such as osmolality, pH and conductivity in addition to filter integrity testing.
• Clearly communicate problems and observations with management from manufacturing and other departments.
• Possess the ability to train junior level manufacturing associates.
• Ensure the timely setup of equipment and materials for each production run.
• Plan and prepare all necessary resources for various processes and activities.
• Assist in other production areas as needed.
• Demonstrate exceptional aseptic techniques with precise, deliberate movements.
• Ensure cleanrooms are cleaned, organized, maintained and audit ready at all times.
• Maintain department inventory and ensure all materials are kitted for upcoming cleanroom operations.
• Plan, organize and maintain material inventory for manufacturing processes.
• Comply with Good Manufacturing Practices (GMP) documentation standards.
• Demonstrate initiative to revise and initiate Batch Production Records, Standard Operation Procedures, study protocols, and reports.
• Attend meetings, participate in continuous improvement projects.
• Demonstrate strong technical writing abilities (Deviation initiations, SOPs, Logbooks, Working Instructions, Forms creation, etc.).
• Prepare media and buffer solutions critical for production processes.
• Adhere to cGMPs (and/or ISO standards) is always required during the manufacture of Bulk Drug products, Final Drug substances and research products.
• Own the quality of what they deliver and is responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

Minimum Qualifications

• BS in Biotechnology, Biology, Chemistry, or equivalent preferred. Preferred area of study: biochemistry or biology.
• 2+ years of experience in GMP manufacturing of biologics, previous experience in downstream process is essential.
• Proven logic and decision-making abilities, critical thinking skills.
• Aseptic practices and clean room operations: Advanced knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Gene/Viral therapy products focusing on Downstream Operations.
• Advanced knowledge of the manufacturing process and possesses the understanding of or ability to use the latest technologies.

Position Type/Expected Hours of Work

This role is a full-time position in Tustin, CA. Days and hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. Must have the ability to be flexible working overtime, weekends and/or holidays when necessary.