Bionova Scientific
Join to apply for the
Upstream Manufacturing Manager
role at
Bionova Scientific Join to apply for the
Upstream Manufacturing Manager
role at
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. 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 Manager, Manufacturing will actively contribute to the manufacturing and technology transfer projects at the Bionova Scientific West Warren site. As part of the Upstream/Manufacturing group, you will have opportunities to work on and take ownership of a wide-ranging set of projects for troubleshooting and investigations, and tech transfers of processes into the GMP manufacturing facility. The position performs professional planning, coordination, analysis and reporting of various project work according to Bionova Scientific guidelines and project management strategies. The role will frequently provide hands-on execution of complex experiments in a team setting. The position will train, supervise, and mentor technical staff. The role will lead GMP manufacturing activities.
Essential Duties and Responsibilities:
Manage manufacturing team to perform complex unit operations including but not limited to Bioreactor operations, depth filtration, media prep, cell culture thaw, expansion and cell banking. Maintains own training within compliance and trains other associates on cell culture operations in GMP environment upon completion of trainer qualification. Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP upstream manufacturing activities. Review and approve technical documents such as tech transfer protocols and reports, and process description. Author, Review and approve production batch records, SOPs, and regulatory filing documents per project needs. Review executed batch records and audit trails to ensure compliance. Documents work according to cGMP and cGDP. Adheres to established regulations and follows cGMP established by site. Maintain cleanroom standards, practices, and housekeeping according to SOPs. Recognize any issues from the equipment and any affiliated documentation and take appropriate corrective action within scope. Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones. Evaluate new technologies and innovations to improve operational efficiency or expand purification capabilities Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control. Present during inspections from regulatory agencies and client audits. Represent the upstream group for cross-functional huddle meetings. Manage staffs to support validation activities as a system owner (URS, SIA, FAT and IOQ).
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:
BS, or MS in Engineering, Life Sciences, or related discipline with 10+ years of relevant experience, or combination of experience and relevant advanced degree in biopharma manufacturing role. In-depth understanding of Cell Culture and industry-standard cell culture processes (scale up, Bioreactor parameters and operations, depth filtration, media and solution prep, etc) and equipment (Cytiva XDR, SUB) Hands-on experience in running, developing, and validating processes. Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing. Experience in leading deviation investigations and authoring quality records such as Events, Change Control and CAPA. Experience with process monitoring software and equipment software (UNICORN, Wonderware) Creative thinker that can identify better and more efficient methods to address issues and gaps. Demonstrate ability to work independently and on cross-functional teams. Strong analytical skills and attention to detail. Effective verbal and written communication skills. Ability to prioritize assignments and to manage multiple projects simultaneously. Capable of independent and rapid decision making based on data, scientific knowledge, and sound judgement Must have the ability to work efficiently in a fast-paced environment. Flexibility with work hours to meet business needs, including weekends and holidays, as needed. Management experience is required. Aseptic technique is a plus.
Compensation Range: The base compensation range for this role is between $120,000 and $150,000. 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. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Management and Manufacturing Referrals increase your chances of interviewing at Bionova Scientific by 2x Sign in to set job alerts for “Manufacturing Manager” roles.
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Upstream Manufacturing Manager
role at
Bionova Scientific Join to apply for the
Upstream Manufacturing Manager
role at
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. 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 Manager, Manufacturing will actively contribute to the manufacturing and technology transfer projects at the Bionova Scientific West Warren site. As part of the Upstream/Manufacturing group, you will have opportunities to work on and take ownership of a wide-ranging set of projects for troubleshooting and investigations, and tech transfers of processes into the GMP manufacturing facility. The position performs professional planning, coordination, analysis and reporting of various project work according to Bionova Scientific guidelines and project management strategies. The role will frequently provide hands-on execution of complex experiments in a team setting. The position will train, supervise, and mentor technical staff. The role will lead GMP manufacturing activities.
Essential Duties and Responsibilities:
Manage manufacturing team to perform complex unit operations including but not limited to Bioreactor operations, depth filtration, media prep, cell culture thaw, expansion and cell banking. Maintains own training within compliance and trains other associates on cell culture operations in GMP environment upon completion of trainer qualification. Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP upstream manufacturing activities. Review and approve technical documents such as tech transfer protocols and reports, and process description. Author, Review and approve production batch records, SOPs, and regulatory filing documents per project needs. Review executed batch records and audit trails to ensure compliance. Documents work according to cGMP and cGDP. Adheres to established regulations and follows cGMP established by site. Maintain cleanroom standards, practices, and housekeeping according to SOPs. Recognize any issues from the equipment and any affiliated documentation and take appropriate corrective action within scope. Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones. Evaluate new technologies and innovations to improve operational efficiency or expand purification capabilities Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control. Present during inspections from regulatory agencies and client audits. Represent the upstream group for cross-functional huddle meetings. Manage staffs to support validation activities as a system owner (URS, SIA, FAT and IOQ).
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:
BS, or MS in Engineering, Life Sciences, or related discipline with 10+ years of relevant experience, or combination of experience and relevant advanced degree in biopharma manufacturing role. In-depth understanding of Cell Culture and industry-standard cell culture processes (scale up, Bioreactor parameters and operations, depth filtration, media and solution prep, etc) and equipment (Cytiva XDR, SUB) Hands-on experience in running, developing, and validating processes. Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing. Experience in leading deviation investigations and authoring quality records such as Events, Change Control and CAPA. Experience with process monitoring software and equipment software (UNICORN, Wonderware) Creative thinker that can identify better and more efficient methods to address issues and gaps. Demonstrate ability to work independently and on cross-functional teams. Strong analytical skills and attention to detail. Effective verbal and written communication skills. Ability to prioritize assignments and to manage multiple projects simultaneously. Capable of independent and rapid decision making based on data, scientific knowledge, and sound judgement Must have the ability to work efficiently in a fast-paced environment. Flexibility with work hours to meet business needs, including weekends and holidays, as needed. Management experience is required. Aseptic technique is a plus.
Compensation Range: The base compensation range for this role is between $120,000 and $150,000. 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. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Management and Manufacturing Referrals increase your chances of interviewing at Bionova Scientific by 2x Sign in to set job alerts for “Manufacturing Manager” roles.
Mountain View, CA $221,298.00-$260,350.00 2 weeks ago Senior Manager, Manufacturing and Operations
Sunnyvale, CA $208,000.00-$293,000.00 1 week ago Milpitas, CA $163,040.00-$239,764.00 1 month ago San Leandro, CA $90,000.00-$100,000.00 2 weeks ago Senior Manager, Manufacturing Operations
Redwood City, CA $165,000.00-$180,000.00 2 weeks ago Fremont, CA $85,300.00-$122,700.00 1 week ago Fremont, CA $154,794.00-$232,190.00 1 week ago Manager/Senior Manager, Advanced Hardware Production
Fremont, CA $215,000.00-$273,000.00 4 days ago Director of Manufacturing, Advanced Process Technologies
Sunnyvale, CA $179,800.00-$317,400.00 1 week ago San Jose, CA $135,000.00-$175,000.00 4 days ago Manufacturing Production Manager JN -072025-163161
Milpitas, CA $169,700.00-$305,700.00 3 weeks ago Director, Global External Manufacturing, OSD
Director, Drug Product Development & Manufacturing
Sr. Manufacturing Technical Manager, AME
Sunnyvale, CA $133,900.00-$231,400.00 2 weeks ago Fremont, CA $112,500.00-$150,000.00 23 hours ago Fremont, CA $72,000.00-$120,000.00 1 month ago Fremont, CA $120,000.00-$150,000.00 1 week ago Milpitas, CA $127,120.00-$177,675.00 1 week ago Fremont, CA $80,000.00-$90,000.00 3 weeks ago Manufacturing Manager, Capital Systems, Ottava
Manufacturing Production Manager JN -082025-163861
San Jose, CA $163,200.00-$204,000.00 2 weeks ago South San Francisco, CA $90,000.00-$210,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr