Bionova Scientific, Inc.
Bioprocess Engineer page is loaded## Bioprocess Engineerremote type:
On-sitelocations:
Fremont, CAtime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R5078## 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:****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:**The Manufacturing Bioprocess Engineer – Downstream is a front-line Subject Matter Expert (SME) responsible for the operational execution of Bionova’s downstream bioprocesses, including chromatography, filtration (depth, TFF, virus filtration), and formulation activities. This role ensures consistent delivery of GMP-compliant drug substance through deviation ownership, process troubleshooting, and continuous improvement. The BPS works closely with manufacturing staff and cross-functional teams to mature Bionova’s purification processes and drive reliable supply.**Essential Duties and Responsibilities:****Operational Support*** Act as SME for downstream operations (column packing, chromatography, UF/DF, filtration, pooling, and formulation).* Provide technical guidance and floor support for real-time issue resolution.* Monitor process data and control parameters to ensure consistent product quality.* Material management and coordination with Supply Chain.**Deviation & Change Management*** Investigate, manage, and own downstream-related deviations in the Quality Management System.* Perform root cause analysis and implement effective CAPAs.* Manage downstream-related change controls and ensure successful implementation.**Training & Knowledge Transfer*** Develop and deliver training on chromatography, filtration, and purification workflows.* Mentor operators on column packing techniques, skid operation, and GMP compliance.* Ensure robust documentation of training activities.* Support MSAT with technology transfer.**Continuous Improvement*** Identify and implement process improvements to increase yield, robustness, and efficiency in downstream operations.* Apply Lean/Six Sigma tools to optimize workflows and reduce variability.**Compliance & Documentation*** Author, revise, and review downstream SOPs, Electronic batch records, and work instructions.* Ensure readiness for audits by maintaining GMP compliance across upstream operations.**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 20 pounds independently.**Qualifications****Education & Experience*** BA/BS in Biological Science, Biotechnology, or Biochemical Engineering with **4 years’ experience** in upstream pharmaceutical manufacturing; OR* MS with **2 years’ experience** in GMP upstream operations.**Required Qualifications*** Hands-on experience with purification unit operations (chromatography, filtration, UF/DF).* Knowledge of process automation platforms (e.g., Unicorn, DeltaV).* Familiarity with biochemical principles underlying protein purification.* Knowledge of process automation and single-use technologies.* Familiarity with scientific principles driving biologics production.* Strong deviation ownership, CAPA development, and technical writing skills.* Ability to troubleshoot complex downstream issues and coach others effectively.* Strong problem-solving and facilitation skills.* Experience in training/mentoring operators in GMP downstream processes.* Project management or Operational Excellence/Six Sigma background.Compensation Range: The base compensation range for this role is between $80,000 and $90,000. However, the actual compensation may vary depending on your experience and qualifications.Health Benefits and Program: Bionova offers health benefits at a subsidized rate.Healthcare, Dental, and Vision insuranceLife Insurance and Disability Program: 100% covered by Bionova.Retirement Plan (401K) Up to 8% of Employer MatchPaid time off up to two weeks10 days of Holidays and 5 days of Sick Leave.*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.*Asahi Kasei in North America emphasizes recruiting key talent within the region. Across our multiple business units, we focus on growth, innovation, and initiative to help develop our people and give them the resources they need to succeed. Part of our mission is to be a good corporate citizen, dedicating our time to employees, customers, and communities around us.As an employer, Asahi Kasei offers a comprehensive benefits package, growth opportunities throughout our companies, and a diverse environment to enhance your career.**About Asahi Kasei**The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age.With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. In North America, Asahi Kasei currently has over 23 business units and 10,000 employees.**Our People**Asahi Kasei recognizes that our people are our greatest strength. We operate with an emphasis on developing our employees and promoting from within. Our broad spectrum of companies within the Material, Homes, and Health Care sectors allows employees to collaborate across locations and industries. The possibilities for employees will continue to grow as we accelerate new business activity internally and externally through mergers and acquisitions. #J-18808-Ljbffr
On-sitelocations:
Fremont, CAtime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R5078## 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:****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:**The Manufacturing Bioprocess Engineer – Downstream is a front-line Subject Matter Expert (SME) responsible for the operational execution of Bionova’s downstream bioprocesses, including chromatography, filtration (depth, TFF, virus filtration), and formulation activities. This role ensures consistent delivery of GMP-compliant drug substance through deviation ownership, process troubleshooting, and continuous improvement. The BPS works closely with manufacturing staff and cross-functional teams to mature Bionova’s purification processes and drive reliable supply.**Essential Duties and Responsibilities:****Operational Support*** Act as SME for downstream operations (column packing, chromatography, UF/DF, filtration, pooling, and formulation).* Provide technical guidance and floor support for real-time issue resolution.* Monitor process data and control parameters to ensure consistent product quality.* Material management and coordination with Supply Chain.**Deviation & Change Management*** Investigate, manage, and own downstream-related deviations in the Quality Management System.* Perform root cause analysis and implement effective CAPAs.* Manage downstream-related change controls and ensure successful implementation.**Training & Knowledge Transfer*** Develop and deliver training on chromatography, filtration, and purification workflows.* Mentor operators on column packing techniques, skid operation, and GMP compliance.* Ensure robust documentation of training activities.* Support MSAT with technology transfer.**Continuous Improvement*** Identify and implement process improvements to increase yield, robustness, and efficiency in downstream operations.* Apply Lean/Six Sigma tools to optimize workflows and reduce variability.**Compliance & Documentation*** Author, revise, and review downstream SOPs, Electronic batch records, and work instructions.* Ensure readiness for audits by maintaining GMP compliance across upstream operations.**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 20 pounds independently.**Qualifications****Education & Experience*** BA/BS in Biological Science, Biotechnology, or Biochemical Engineering with **4 years’ experience** in upstream pharmaceutical manufacturing; OR* MS with **2 years’ experience** in GMP upstream operations.**Required Qualifications*** Hands-on experience with purification unit operations (chromatography, filtration, UF/DF).* Knowledge of process automation platforms (e.g., Unicorn, DeltaV).* Familiarity with biochemical principles underlying protein purification.* Knowledge of process automation and single-use technologies.* Familiarity with scientific principles driving biologics production.* Strong deviation ownership, CAPA development, and technical writing skills.* Ability to troubleshoot complex downstream issues and coach others effectively.* Strong problem-solving and facilitation skills.* Experience in training/mentoring operators in GMP downstream processes.* Project management or Operational Excellence/Six Sigma background.Compensation Range: The base compensation range for this role is between $80,000 and $90,000. However, the actual compensation may vary depending on your experience and qualifications.Health Benefits and Program: Bionova offers health benefits at a subsidized rate.Healthcare, Dental, and Vision insuranceLife Insurance and Disability Program: 100% covered by Bionova.Retirement Plan (401K) Up to 8% of Employer MatchPaid time off up to two weeks10 days of Holidays and 5 days of Sick Leave.*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.*Asahi Kasei in North America emphasizes recruiting key talent within the region. Across our multiple business units, we focus on growth, innovation, and initiative to help develop our people and give them the resources they need to succeed. Part of our mission is to be a good corporate citizen, dedicating our time to employees, customers, and communities around us.As an employer, Asahi Kasei offers a comprehensive benefits package, growth opportunities throughout our companies, and a diverse environment to enhance your career.**About Asahi Kasei**The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age.With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. In North America, Asahi Kasei currently has over 23 business units and 10,000 employees.**Our People**Asahi Kasei recognizes that our people are our greatest strength. We operate with an emphasis on developing our employees and promoting from within. Our broad spectrum of companies within the Material, Homes, and Health Care sectors allows employees to collaborate across locations and industries. The possibilities for employees will continue to grow as we accelerate new business activity internally and externally through mergers and acquisitions. #J-18808-Ljbffr