Bionova Scientific
Associate Scientist/Sr. Associate Scientist
Bionova Scientific, Fremont, California, us, 94537
Company Summary
Bionova Scientific LLC is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. The company is a subsidiary of Asahi Kasei Medical, part of the Asahi Kasei Group. Bionova emphasizes a culture of top scientific talent, advanced tools, and an agile, energized environment focused on solving difficult client problems.
Position Summary Bionova is seeking a motivated and innovative Associate Scientist/Sr. Associate Scientist to work in the Purification Development group within the Purification Process Development management. The role supports a wide-ranging set of projects from process development, 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 frequently provides support the execution of complex experiments in a team setting.
Essential Duties and Responsibilities
Develop and optimize downstream purification processes for biologic products, ensuring the processes are scalable and reproducible.
Lead process development activities for large-scale production runs, ensuring timelines and quality standards are met.
Design, execute, and analyze experiments to improve process efficiency and product yield.
Manage tech transfers of developed processes from R&D to pilot and commercial scale manufacturing.
Work closely with cross-functional teams (e.g., upstream process development, analytical and formulation, MSAT, quality control, and manufacturing) to ensure smooth integration of processes.
Provide technical leadership during troubleshooting, root cause analysis, and continuous improvement initiatives.
Prepare and review technical documentation, including protocols, reports, and regulatory submissions.
Support compliance with cGMP, regulatory requirements, and internal policies during all stages of process development and tech transfer.
Ensure seamless communication with team members to ensure alignment on project milestones and deliverables.
Working Conditions
This position requires working in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.
Qualifications
BS/MS/PhD in Biological Sciences or related disciplines.
BS with 5 years, MS with 3 years, PhD with 0-2 years of relevant industry experience.
Understanding of protein chemistry and industry-standard purification processes would be preferred (affinity, IEX, MMC, SEC, viral inactivation and filtration, depth filtration, TFF, UFDF, etc) and equipment (GE AKTAs, disposables)
Experience in running, developing, and validating processes would be a plus.
Compensation and Benefits Compensation range: Base salary between $75,000 and $100,000. Actual compensation may vary based on experience and qualifications.
Health benefits: subsidized health insurance, dental, vision. Life insurance and disability program fully covered. Retirement plan: 401(k) with up to 8% employer match. Paid time off up to two weeks, 10 days of holidays, and 5 days of sick leave.
Equal Opportunity Employer As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
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Position Summary Bionova is seeking a motivated and innovative Associate Scientist/Sr. Associate Scientist to work in the Purification Development group within the Purification Process Development management. The role supports a wide-ranging set of projects from process development, 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 frequently provides support the execution of complex experiments in a team setting.
Essential Duties and Responsibilities
Develop and optimize downstream purification processes for biologic products, ensuring the processes are scalable and reproducible.
Lead process development activities for large-scale production runs, ensuring timelines and quality standards are met.
Design, execute, and analyze experiments to improve process efficiency and product yield.
Manage tech transfers of developed processes from R&D to pilot and commercial scale manufacturing.
Work closely with cross-functional teams (e.g., upstream process development, analytical and formulation, MSAT, quality control, and manufacturing) to ensure smooth integration of processes.
Provide technical leadership during troubleshooting, root cause analysis, and continuous improvement initiatives.
Prepare and review technical documentation, including protocols, reports, and regulatory submissions.
Support compliance with cGMP, regulatory requirements, and internal policies during all stages of process development and tech transfer.
Ensure seamless communication with team members to ensure alignment on project milestones and deliverables.
Working Conditions
This position requires working in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.
Qualifications
BS/MS/PhD in Biological Sciences or related disciplines.
BS with 5 years, MS with 3 years, PhD with 0-2 years of relevant industry experience.
Understanding of protein chemistry and industry-standard purification processes would be preferred (affinity, IEX, MMC, SEC, viral inactivation and filtration, depth filtration, TFF, UFDF, etc) and equipment (GE AKTAs, disposables)
Experience in running, developing, and validating processes would be a plus.
Compensation and Benefits Compensation range: Base salary between $75,000 and $100,000. Actual compensation may vary based on experience and qualifications.
Health benefits: subsidized health insurance, dental, vision. Life insurance and disability program fully covered. Retirement plan: 401(k) with up to 8% employer match. Paid time off up to two weeks, 10 days of holidays, and 5 days of sick leave.
Equal Opportunity Employer As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
#J-18808-Ljbffr