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 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.

Position Summary:

The Scientist/ Sr Scientist, Cell Culture will actively contribute to the develop and execute cell culture processes and technology transfer projects.  As part of the Cell Culture group, you will have opportunities to work on and take ownership of a wide-ranging set of projects for troubleshooting and investigations, system and workflow implementation, and tech transfers of processes into a GMP mulit-product 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 execution support and single-use assembly design.

Essential Duties and Responsibilities:

• Executes, with oversight of qualified staff, complex unit operations including but not limited to media prep; cell culture thaw, expansion, and end of production banking; operation of single-use bioreactors, process monitoring and harvest operations.  
• Manges and executes along with the team lab management activities
• Maintains own training within compliance and trains other PD associates upon completion of trainer qualification.
• Leads and performs equipment and process development troubleshooting if required, at pilot scale and development lab scale.
• Author/review/approve technical documents such as tech transfer protocols and reports, experimental plans, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.
• Documents work according to cGMP and cGDP. 
• 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.  
• 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 cell culture capabilities.
• Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control.  
• Collaborate with other departments for raw materials, water, testing requirements, documentation, validation, maintenance, and scheduling
• While performing duties of this job, the role requires walking, standing, stooping, kneeling, and crouching.  The employee must occasionally lift and or move up to 20 pounds independently.  
• Present during inspections from regulatory agencies and client audits

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:

• Ph.D. with 2 years, MS with 4 years or BS with 6 years experiences in the biotech industry or related disciplines.
• Must have bioreactor operations experience.
• In-depth understanding of mammalian cell culture performance is required.
• Experience in process development, process characterization and/or tech. transfer processes.
• Knowledge on CMC development is a plus.
• Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing are beneficial.
• Experience with process monitoring software and equipment software (e.g. UNICORN, Pi Historian, Spotfire).
• Knowledge in statistical software is a plus.
• 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.

Compensation Range: The base compensation range for this role is between $100,000 and $130,000. However, the actual compensation may vary depending on your experience and qualifications.

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.