Associate Scientist II

Asahi Kasei•Fremont, CA

1d•Onsite

About The Position

Bionova is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. As a subsidiary of Asahi Kasei Medical since May 2022, Bionova is accelerating its growth and expanding service offerings. The company is seeking an experienced Associate Scientist to perform analytical testing to support process development, process characterization studies, and stability studies. This role involves participating in the development, optimization, and potential qualification of various analytical test methods.

Requirements

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.

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.