Manufacturing Associate, pDNA

Asahi Kasei • The Woodlands, TX

24d • Onsite

About The Position

Bionova is seeking for Manufacturing Associate, to support plasmid DNA production through upstream and downstream unit operations. This role executes GMP manufacturing processes, documents activities accurately, and supports a safe, compliant manufacturing environment.

Requirements

• High School Diploma or GED required; Associate or bachelor’s degree in Life Sciences preferred
• 1–3+ years of GMP manufacturing experience (biotech, pharma, or CDMO preferred)
• Hands-on experience with upstream operations or similar biological processes
• Ability to follow detailed procedures and work in a regulated environment
• Comfortable working in cleanroom/gowning environments

Responsibilities

• Execute GMP plasmid DNA upstream and downstream production activities within a GMP environment. More specifically, prepare and setup fermenters, centrifuges, mixing and filtration systems and chromatography skids. In addition, weigh and measure raw materials, and prepare media and buffer solutions
• Follow cGMP and cGDP practices, Maintain accurate and detailed records of all operations in accordance to the standard operating procedures (SOPs), work instructions and batch records.
• Ensure compliance with cGMPs and other regulatory requirements, including safety and quality standards.
• Perform routine equipment maintenance and troubleshooting of bioprocessing equipment. Assist in the identification and resolution of equipment issues that arise during production to ensure proper function and prevent downtime.
• Support manufacturing investigations and non-conformities to products that impact their safety and efficacy.
• Participate in process improvement initiatives to enhance efficiency, yield and product quality.
• Stay current with industry trends and best practices and participate in training program to develop new skills and knowledge.
• Communicate effectively with managers and team members to report production progress, issues, and improvements.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees