Manufacturing Associate

Bionova Scientific LLC

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products. As part of our business expansion plan, we are building a state-of-the-art facility that specializes in the development and manufacturing of Plasmid DNA. This facility will be equipped with cutting-edge technology and staffed by a team of highly skilled professionals who are dedicated to advancing the field of Plasmid DNA process development and manufacturing. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client challenges.

Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.

Position Summary

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.

Essential Duties and 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.

Working Conditions

• This position requires working in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 40 pounds independently.

Qualifications

• High School Diploma or GED required; Associate or bachelor's degree in Life Sciences preferred
• 13+ 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

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.