Sr. Scientist, PD DS

Company Summary:

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.

Position Summary:

Bionova is seeking a motivated and innovative scientist looking to serve as Sr. Scientist in the Purification Development group. As part of the Purification Process Development management, 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, and tech transfers of processes into the development space as well as the GMP manufacturing facility. The role will frequently provide hands-on execution of complex experiments in a team setting.

Essential Duties and Responsibilities:

• Take part in development, optimization, and validation of purification processes as well as process transfers to and from client sites.
• Specify and source new downstream purification equipment to expand the purification capabilities of the downstream development laboratory
• The Senior Scientist keeps an up-to-date awareness of advances in multiple technological and scientific areas and has strong academic and industrial contacts
• Supervision or mentoring other colleagues providing guidance, coaching and career development support is required
• Will be responsible for leading multiple client projects in parallel for protein purification
• Work with senior leadership on developing downstream purification processes for client projects along with innovative internal experiments
• Support Manufacturing groups be leveraging protein purification expertise to support investigations and/or generation, review, and interpretation of purification results
• Project management and coordination of various high impact internal and external projects
• Author/review/approve technical documents such as process development reports, tech transfer protocols and reports, 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
• 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
• Guide and train other colleagues providing guidance, coaching and career development support is required

Working Conditions:

This position is required to work in an office and laboratory setting.

Qualifications:

• BS/MS in Biological Sciences or related disciplines with 6+ years for BS, 4+ years for MS
• In-depth understanding of protein chemistry and industry-standard purification processes (affinity, IEX, MMC, SEC, viral inactivation and filtration, depth filtration, TFF, UFDF, etc) and equipment (GE AKTAs, disposables)
• Hands-on experience in running, developing, and validating processes
• Scientist leads multiple client projects to meet timeline, budget and scope commitments and has a good working knowledge of protein purification pertaining to the drug development process and knowledge of relevant business elements