Associate Scientist II, PD Downstream

akamerica; Fremont (CA); On-site; USD 75,000 - 80,000; Full time

Job summary

Bionova Scientific LLC in Fremont, California, seeks an Associate Scientist II, PD Downstream, to develop downstream purification processes for mAbs and other proteins within the Purification Development group.

You will own projects, troubleshoot, and transfer tech to manufacturing, applying protein chemistry knowledge and DoE concepts in a collaborative, fast-paced environment.

Qualifications

• BS/MS in Biological Sciences or related discipline.
• 2–4 years of relevant industry experience.
• Strong knowledge of purification processes (affinity, IEX, MMC, SEC, viral inactivation and filtration, depth filtration, TFF, UFDF).

Responsibilities

• Support development, optimization, and validation of purification workflows and tech transfers.
• Develop tools to enable scale-up and technology transfer at first pass.
• Support multiple client projects in parallel for protein purification.
• Collaborate with senior leadership on downstream purification processes.
• Generate ideas for continuous improvement and internal capabilities.
• Assist in generating and reviewing technical documents and regulatory filings.

Skills

Protein purification

Protein chemistry

Communication

Team collaboration

DoE understanding

Education

BS in Biological Sciences

MS in Biological Sciences

Tools

AKTAs

Job description

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 is seeking a motivated and innovative Scientist in the Purification Development group developing downstream processes for mAbs, bispecifics, enzymes, recombinant proteins, Fc fusions, etc. As our Associate Scientist II, PD Downstream , you will be part of the Purification Process Development, you will have opportunities to work on and take ownership of a wide-ranging set of projects in process development, troubleshooting and investigations, system and workflow implementation, client interactions, and tech transfers of processes into the manufacturing space.

Location:

Fremont, California

Essential Duties and Responsibilities:

• Support the development, optimization, and validation of purification workflows as well as process transfers to and from client sites.
• Develop appropriate tools and technologies to enable right at first pass scale-up and technology transfer.
• Supporting multiple client projects in parallel for protein purification.
• Work with senior leadership on developing downstream purification processes for client projects.
• Generate ideas for continuous improvement and innovative internal capabilities.
• Support Manufacturing groups by leveraging protein purification expertise to support investigations and/or generation, review, and interpretation of purification results as needed.
• Assist in Author/review technical documents such as process development reports, tech transfer protocols and reports, and regulatory filing documents per project need.
• Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.
• Assist in Interpreting 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.

Working Conditions:

This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 40 pounds independently.

Qualifications:

• BS/MS in Biological Sciences or related disciplines
• 2-4 years of relevant industry experience.
• 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 (AKTAs)
• Familiarity with JMP statistics and DoE setup is a plus.
• Demonstrate excellent communication skills and specifically illustrate strong oral and written technical communications.
• Seamlessly present experimental outcomes to multifunctional teams
• Be a strong team player in a cross functional collaborative environment and maintain strong working relationships with internal, global, and external collaborators.
• Demonstrated problem-solving skills and capability to overcome complex issues.
• Demonstrated success in coordinating and executing important projects to achieve business goals.
• Must have results-oriented work ethic and positive can-do attitude with a strong sense of urgency and self-motivated desire to achieve.
• Experience in managing or contributing to multiple projects simultaneously would be preferred.

Compensation:

The base compensation range for this role is $75,000-$80,000. 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 conditi