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Associate Scientist, Upstream Process Development

Asahi Kasei Advance America

The Woodlands, Texas

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JOB DETAILS
SKILLS
Analytical Development, Asepsis, Best Practices, Biology, Business Growth, Business Plan, Cell Cultures, Communication Skills, Cross-Functional, Customer Relations, DNA, Data Analysis, Detail Oriented, Documentation, Fermentation, GMP (Good Manufacturing Practices), Healthcare, Identify Issues, Industry/Trade Analysis, Leading Edge Technology, Manufacturing, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Process Development, Process Improvement, Process Manufacturing, Progress Reports, Quality Assurance Methodology, Regulations, Reporting Skills, Resolve Customer Issues, Root Cause Analysis, Standard Operating Procedures (SOP), Test Plan/Schedule, Training Program Development
LOCATION
The Woodlands, Texas
POSTED
Today
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 associate scientist to perform fermentation and clarification process development activities to advance plasmid DNA, GMP manufacturing efforts. The associate scientist will participate in development, optimization and technology transfer processes.

Essential Duties and Responsibilities:
  • Execute fermentation and clarification development experiments, analyze data and generate reports.
  • Perform fermentation and clarification activities to support process development decisions and process characterization studies.
  • Ability to follow procedural instructions in standard operating procedures (SOPs), work instructions (WI) and development test methods.
  • Draft SOPs, experimental procedures and development batch records.
  • Ensure work follows Good Documentation Practices (GDP) and maintain accurate and detailed records of analytical development activities.
  • Ensure all process development and testing activities adhere to applicable regulatory guidance and industry best practices.
  • Troubleshoot fermentation equipment and assist in the identification and resolution of equipment issues.
  • Support development investigations and non-conformities.
  • Participate in process improvement initiatives to enhance efficiency and product quality.
  • Stay current with industry trends and best practices and participate in training programs 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 1-2 years of relevant fermentation or cell culture experience.
  • Hands-on experience in bioprocessing (fermenters, centrifugation, single-use equipment and assemblies, aseptic technique).
  • Ability to troubleshoot process failures related to equipment 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 communicat

About the Company

A

Asahi Kasei Advance America

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