Scientist I, Downstream
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:

The Scientist I, Downstream will actively contribute to the development and execution of purification processes and technology transfer projects. As part of the purification group, you will have opportunities to develop and own a wide-ranging set of projects from troubleshooting and investigations, system and workflow implementation, and tech transfers of processes into a GMP manufacturing facility. The position performs professional planning, coordination, analysis, and reporting of various project work according to Bionova Scientific guidelines and project management strategies. The role will frequently provide hands-on execution of complex experiments in a team setting. The position will train, supervise, and mentor technical staff with opportunities for growth into management. The scope of responsibilities may include but are not limited to document writing (SOPs, Equipment URSs, etc.), equipment validation support and single-use assembly design.

Essential Duties and Responsibilities:

• Executes, with oversight of qualified staff, complex unit operations including but not limited to solution prep, harvest operations, tangential flow filtration, chromatography, product filling, operation of single-use purification systems and process monitoring.
• Authors/reviews/approves technical documents such as tech transfer protocols and development reports, experimental plans, batch records, training materials, and SOPs per project needs.
• Performs internal support activities such as maintenance of processing equipment, stocking of consumables, discarding expired reagents, material coordination and weigh and dispense.
• Maintains own training within compliance and trains other PD associates upon completion of trainer qualification.
• Support in equipment troubleshooting, pilot scale material generation, non-GMP material generation.
• Documents work according to current Good Documentation Practices.
• Maintain cleanroom standards, practices, and housekeeping according to SOPs.
• Recognize any minor issues from the equipment and any affiliated documentation and take appropriate corrective action within scope. Notify managers and leads of issues and discrepancies immediately.
• Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.
• Evaluate new technologies and innovations to improve operational efficiency or expand purification capabilities.

Working Conditions:

• This position required to work 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 Engineering, Life Sciences, or related discipline with 5-8 years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
• Must have TFF and chromatography operations experience.
• In-depth understanding of purification unit operations is required.
• Hands-on experience in running and developing processes
• Experience in process development, process characterization and/or technology transfer processes.
• Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing
• 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.
• Ability to handle more than one task at a time, while maintaining attention to detail and working in a fast-paced environment.
• Strong analytical skills and attention to detail.
• Effective verbal and written communication skills
• Must be able to work independently as well as work with a diverse team.
• Must have the ability to work efficiently in a fast-paced environment.
• Flexibility with work hours to meet business needs, including weekends and holidays, as needed.

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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