Associate Scientist I / II

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 Bionova, an Asahi Kasei company, is seeking an experienced 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. Location: Fremont, California Essential Duties and Responsibilities Develop, optimize, qualify, and validate analytical test methods such as UV‑Vis, HPLC/UPLC, CE, icIEF, ELISA, CBAs, Octet, qPCR, mass spectrometry, and many others. Perform analytical testing to support cell line development, upstream and downstream process development, formulation development, process characterization studies, and stability studies. Author technical documents such as method development reports, feasibility reports, method transfer protocols/reports, method validation and qualification protocols/reports, and regulatory filing documents per project needs. Draft SOPs for laboratory and assay procedures. Prepare concise, sound scientific presentations of study results to the management team and external clients. Support the investigation of CMC issues and non‑conformities to products that impact their safety and efficacy. Evaluate new technologies and innovations to improve operational efficiency or expand department capabilities. Support QC in method transfer, analyst training and troubleshooting during method qualification and testing. Assist in client audits and inspections from regulatory agencies, as needed. Interpret analytical data to support a variety of initiatives and make recommendations for best courses of action as they pertain to drug development. 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 2+ years of relevant research and/or industry experience in Analytical development, Formulation development, or Quality Control. In-depth understanding of protein chemistry and industry‑standard analytical tools (CE, HPLC/UPLC, Mass Spec, ELISA, qPCR assays, compendial assays, etc.). Hands‑on experience in running, developing, qualifying, and validating analytical methods. Ability to troubleshoot assay failure 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. The base compensation range for this role is $85,000-$100,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions. 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. #J-18808-Ljbffr Bionova Scientific