Fremont, CA · Full time
Bionova is seeking a motivated and innovative scientist looking to serve as a leader in the Purification/Manufacturing group. As part of the Purification/Manufacturing group, you will have opportunities to work on and take ownership of a wide-ranging set of projects from process development, to troubleshooting and investigations, system and workflow implementation, facility buildout, and tech transfers of processes into the development space as well as the GMP manufacturing facility. Bionova is currently in the process of expanding its capabilities from a CDO to a CDMO through construction of a state-of-the-art GMP disposables manufacturing facility. As part of the rapidly growing Purification /Manufacturing team, you will be able to make decisions and influence changes from the ground floor as we grow the organization and expand capabilities to meet project goals that ultimately will improve patient outcomes.
Mentor and train junior staff members by providing guidance on scientific principles and their practical applications to protein purification
Lead establishment of the downstream manufacturing function through implementation of cGMP procedures, processes, systems, and personnel
Lead conversations during facility build and design for the downstream function and create process flow diagrams in preparation of bringing GMP manufacturing facility online
Project management and coordination of various high impact internal and external projects
Oversee development, optimization, and validation of purification processes as well as process transfers to and from client sites.
Author/review/approve technical documents such as process development reports, tech transfer protocols and reports, manufacturing SOPs, and regulatory filing documents per project needs
Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones
Lead meetings with clients to move projects forward and/or triage issues
Evaluate new technologies and innovations to improve operational efficiency or expand purification capabilities
Interpret data from studies and make recommendations for best courses of action as they pertain to drug and process development
Troubleshoot equipment and testing to identify root causes of issues
Present during inspections from regulatory agencies and client audits
BS, MS, or PhD in Biological Sciences or related disciplines with 10+ years of relevant research and/or industry experience.
In-depth understanding of protein chemistry and industry-standard purification processes (affinity, IEX, SEC, viral inactivation and filtration, depth filtration, TFF, UFDF, etc) and equipment (GE AKTAs, disposables)
Hands-on experience in running, developing, and validating 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
Experience with process monitoring software and equipment software (UNICORN, Pi Historian)
Demonstrate ability to work independently and on cross-functional teams
Strong attention to detail
Effective verbal and written communication skills
Management experience is a plus
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older.