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Purification Scientist

Fremont, CA · Full time


Job Description

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.

Duties & Responsibilities

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

Requirements

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

Eligibility Requirements

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.

Ready to Apply?

Send your cover letter and resume to the email address below.

Email us

careers@bionovascientific.com