Senior Associate Scientist, Plasmid DNA Manufacturing
Bionova Scientific LLC

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. 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 problems. 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. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.

Company:
Bionova Scientific LLC

Job Description:

Company Summary:

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 an experienced manufacturing associate scientist to perform analytical testing to support process development, process characterization studies, and stability studies. The associate scientist will participate in development, optimization, and possibly qualification of analytical test methods.

Essential Duties and Responsibilities:

• Execute GMP plasmid DNA upstream and downstream production activities within a GMP environment. More specifically, prepare and setup fermentors, centrifuges, mixing and filtration systems and chromatography skids. In addition, weigh and measure raw materials, and prepare media and buffer solutions
• Ability to follow procedural instructions in standard operating procedures (SOPs), work instructions (WI) and batch records.
• Ensure work follows current Good Manufacturing Practices (cGMP) and Good Documentation Practices (cGDP). Maintain accurate and detailed records of all operations.
• 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 20 pounds independently.

Qualifications:

• BS or MS in Biological Sciences or related disciplines with 5+ years of relevant GMP manufacturing experience in bioprocessing
• Hands-on experience in running bioprocessing equipment (fermentors, centrifuges, tangential flow filtration and chromatography systems). Experience with single-use process technologies.
• Ability to troubleshoot process failures related to equipment or execution and identify root cause.
• Creative thinker that can identify better and more efficient methods to address issues and gaps.
• Demonstrate ability to work independently and on cross-functional teams.
• Strong attention to detail.
• Effective verbal and written communication skills.
• Enthusiastic learner.

Health Benefits and Program: Bionova offers health benefits at a subsidized rate.

Healthcare, Dental, and Vision insurance

Life Insurance and Disability Program: 100% covered by Bionova.

Retirement Plan (401K) Up to 8% of Employer Match

Paid time off up to two weeks

10 days of Holidays and 5 days of Sick Leave.

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.

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