Bionova Scientific
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.
Company:
Bionova Scientific LLC Job Description: 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. Essential Duties and Responsibilities: 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 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: 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. Health Benefits and Program: Bionova offers health benefits at a subsidized rate. 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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Bionova Scientific LLC Job Description: 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. Essential Duties and Responsibilities: 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 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: 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. Health Benefits and Program: Bionova offers health benefits at a subsidized rate. 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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