Asahi Kasei
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 Senior Manager, Upstream Manufacturing will provide strategic and operational leadership for GMP upstream manufacturing activities. This role is accountable for ensuring successful execution of client manufacturing campaigns, seamless technology transfers, and continuous improvement of upstream processes within a contract development and manufacturing (CDMO) environment.
As a senior leader within the Manufacturing organization, you will oversee the planning, coordination, and execution of upstream operations, including seed train expansion, bioreactor operations, troubleshooting, and deviation/investigation management. You will partner closely with MSAT, Process Development, Quality, and Project Management teams to ensure robust, compliant, and efficient production of biologics for clients.
Essential Duties and Responsibilities:
Lead and Oversee GMP Operations - Direct and supervise complex upstream unit operations including bioreactor operations, depth filtration, and media preparation, ensuring consistent, compliant, and high-quality execution. Team Training & Development - Maintain personal compliance training and actively train, mentor, and qualify associates in upstream operations, fostering technical growth and adherence to GMP standards. Technical Troubleshooting & Support - Provide oversight and guidance in equipment troubleshooting, pilot-scale production, non-GMP tox material generation, and GMP upstream manufacturing, ensuring rapid issue resolution and minimal impact to client programs. Documentation & Compliance Ownership - Author, review, and approve technical documentation including technology transfer protocols, experimental plans, batch records, training materials, SOPs, and regulatory submissions, ensuring alignment with project requirements and global standards. cGMP & cGDP Compliance - Uphold site-wide compliance by documenting activities accurately, following GMP regulations, and enforcing cleanroom standards, practices, and housekeeping. Issue Identification & Resolution - Recognize operational and documentation-related issues, assess potential impact on product quality, safety, or project timelines, and drive corrective and preventive actions. Continuous Improvement & Innovation - Evaluate and implement new upstream technologies and operational strategies to enhance efficiency, scalability, and robustness of manufacturing operations. Quality & Regulatory Support - Actively contribute to investigations, deviations, CAPAs, change controls, and area walk-throughs, ensuring quality and compliance are embedded in day-to-day operations. Audit & Client Interaction - Represent the upstream manufacturing function during regulatory inspections and client audits, providing subject matter expertise, transparent communication, and confidence in CDMO execution capabilities. Cross-functional & Client Collaboration - Partner with MSAT, Process Development, Quality, and Project Management to ensure smooth technology transfer, operational readiness, and clear communication of project status to internal stakeholders and clients. Working Conditions:
This position required to work in a clean room and 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 - BS or MS in Engineering, Life Sciences, or related discipline with 10+ years of relevant biopharmaceutical manufacturing experience (or equivalent combination of education and experience), including 5+ years in GMP upstream operations leadership within a CDMO or biopharma environment. Technical Expertise - Deep understanding of cell culture operations and scale-up strategies, including bioreactor design and parameters, depth filtration, and media/solution preparation. Familiarity with industry-standard equipment (e.g., Cytiva XDR, SUBs) and process monitoring systems. GMP & Regulatory Knowledge - Extensive experience with cGMP compliance and global regulatory expectations, including authorship and approval of technical documents (batch records, SOPs, protocols, regulatory filings). Demonstrated success in supporting regulatory inspections and client audits. Leadership & People Management - Proven ability to lead and develop high-performing teams, including training, mentoring, and performance management of technical staff. Strong track record of fostering a culture of accountability, collaboration, and continuous improvement. Tech Transfer & CDMO Experience - Demonstrated success in leading technology transfer projects, collaborating with clients and internal teams to ensure seamless process adoption into GMP facilities. Analytical & Problem-Solving Skills - Strong ability to interpret complex data, drive root cause analyses, and make independent, data-driven decisions under time-sensitive conditions. Operational Excellence - Experience in implementing process improvements, digital workflows, and lean initiatives to enhance efficiency and scalability in upstream operations. Communication & Collaboration - Excellent written and verbal communication skills with the ability to effectively interact with clients, cross-functional partners, and senior leadership. Business Acumen & Adaptability - Capable of balancing multiple client projects in a dynamic CDMO setting, adapting to evolving priorities while ensuring delivery of high-quality results. Flexibility - Willingness to adjust work schedule, including occasional weekends and holidays, to meet manufacturing and client program timelines.
Compensation Range: The base compensation range for this role is between $120,000 and $160,000. 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 insurance
Life Insurance and Disability Program: 100% covered by Bionova.
Retirement Plan (401K) Up to 8% of Employer Match
Paid time off up to two weeks
10 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.
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 Senior Manager, Upstream Manufacturing will provide strategic and operational leadership for GMP upstream manufacturing activities. This role is accountable for ensuring successful execution of client manufacturing campaigns, seamless technology transfers, and continuous improvement of upstream processes within a contract development and manufacturing (CDMO) environment.
As a senior leader within the Manufacturing organization, you will oversee the planning, coordination, and execution of upstream operations, including seed train expansion, bioreactor operations, troubleshooting, and deviation/investigation management. You will partner closely with MSAT, Process Development, Quality, and Project Management teams to ensure robust, compliant, and efficient production of biologics for clients.
Essential Duties and Responsibilities:
Lead and Oversee GMP Operations - Direct and supervise complex upstream unit operations including bioreactor operations, depth filtration, and media preparation, ensuring consistent, compliant, and high-quality execution. Team Training & Development - Maintain personal compliance training and actively train, mentor, and qualify associates in upstream operations, fostering technical growth and adherence to GMP standards. Technical Troubleshooting & Support - Provide oversight and guidance in equipment troubleshooting, pilot-scale production, non-GMP tox material generation, and GMP upstream manufacturing, ensuring rapid issue resolution and minimal impact to client programs. Documentation & Compliance Ownership - Author, review, and approve technical documentation including technology transfer protocols, experimental plans, batch records, training materials, SOPs, and regulatory submissions, ensuring alignment with project requirements and global standards. cGMP & cGDP Compliance - Uphold site-wide compliance by documenting activities accurately, following GMP regulations, and enforcing cleanroom standards, practices, and housekeeping. Issue Identification & Resolution - Recognize operational and documentation-related issues, assess potential impact on product quality, safety, or project timelines, and drive corrective and preventive actions. Continuous Improvement & Innovation - Evaluate and implement new upstream technologies and operational strategies to enhance efficiency, scalability, and robustness of manufacturing operations. Quality & Regulatory Support - Actively contribute to investigations, deviations, CAPAs, change controls, and area walk-throughs, ensuring quality and compliance are embedded in day-to-day operations. Audit & Client Interaction - Represent the upstream manufacturing function during regulatory inspections and client audits, providing subject matter expertise, transparent communication, and confidence in CDMO execution capabilities. Cross-functional & Client Collaboration - Partner with MSAT, Process Development, Quality, and Project Management to ensure smooth technology transfer, operational readiness, and clear communication of project status to internal stakeholders and clients. Working Conditions:
This position required to work in a clean room and 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 - BS or MS in Engineering, Life Sciences, or related discipline with 10+ years of relevant biopharmaceutical manufacturing experience (or equivalent combination of education and experience), including 5+ years in GMP upstream operations leadership within a CDMO or biopharma environment. Technical Expertise - Deep understanding of cell culture operations and scale-up strategies, including bioreactor design and parameters, depth filtration, and media/solution preparation. Familiarity with industry-standard equipment (e.g., Cytiva XDR, SUBs) and process monitoring systems. GMP & Regulatory Knowledge - Extensive experience with cGMP compliance and global regulatory expectations, including authorship and approval of technical documents (batch records, SOPs, protocols, regulatory filings). Demonstrated success in supporting regulatory inspections and client audits. Leadership & People Management - Proven ability to lead and develop high-performing teams, including training, mentoring, and performance management of technical staff. Strong track record of fostering a culture of accountability, collaboration, and continuous improvement. Tech Transfer & CDMO Experience - Demonstrated success in leading technology transfer projects, collaborating with clients and internal teams to ensure seamless process adoption into GMP facilities. Analytical & Problem-Solving Skills - Strong ability to interpret complex data, drive root cause analyses, and make independent, data-driven decisions under time-sensitive conditions. Operational Excellence - Experience in implementing process improvements, digital workflows, and lean initiatives to enhance efficiency and scalability in upstream operations. Communication & Collaboration - Excellent written and verbal communication skills with the ability to effectively interact with clients, cross-functional partners, and senior leadership. Business Acumen & Adaptability - Capable of balancing multiple client projects in a dynamic CDMO setting, adapting to evolving priorities while ensuring delivery of high-quality results. Flexibility - Willingness to adjust work schedule, including occasional weekends and holidays, to meet manufacturing and client program timelines.
Compensation Range: The base compensation range for this role is between $120,000 and $160,000. 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 insurance
Life Insurance and Disability Program: 100% covered by Bionova.
Retirement Plan (401K) Up to 8% of Employer Match
Paid time off up to two weeks
10 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.