Bionova Scientific, Inc.
Sr. Associate Scientist page is loaded## Sr. Associate Scientistremote type:
On-sitelocations:
Fremont, CAtime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R5072## 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
Sr Associate Scientist, Cell Culture will actively contribute to the develop and execute cell culture processes and technology transfer projects.
As part of the Cell Culture group, you will have opportunities to work on and take ownership of a wide-ranging set of projects for troubleshooting and investigations, system and workflow implementation, and tech transfers of processes into a GMP mulit-product 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 scope of responsibilities may include but are not limited to Document writing (SOPs, Equipment URSs, etc.), equipment validation execution support and single-use assembly design.**Essential Duties and Responsibilities:*** Executes complex unit operations including but not limited to media prep; cell culture thaw, expansion, and end of production banking; operation of single-use bioreactors, process monitoring and harvest operations.* Performs internal support activities such as maintenance of analytical equipment, stocking of consumables, discarding expired reagents, material coordination and weigh and dispense.* Maintains own training within compliance and trains other PD associates upon completion of trainer qualification.* Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation.* Author/review/approve technical documents such as tech transfer protocols and reports, experimental plans, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.* Documents work according to cGMP and cGDP.* Maintain cleanroom standards, practices, and housekeeping according to SOPs.* Recognize any minor issues from the equipment and any affiliated documentation and take appropriate corrective action within scope.
Notify supervisors and leads of issues and discrepancies immediately.* Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.* Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control.* Collaborate with other departments for raw materials, water, testing requirements, documentation, validation, maintenance, and scheduling* While performing duties of this job, the role requires walking, standing, stooping, kneeling, and crouching.
The employee must occasionally lift and or move up to 20 pounds independently.* Present during inspections from regulatory agencies and client audits as needed.**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 in Engineering, Life Sciences, or related discipline with 2-4 years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.* Must have bioreactor operations experience.* In-depth understanding of mammalian cell culture performance is required.* Hands-on experience in running, developing, and validating processes* Experience in process development, process characterization and/or tech. transfer processes.* Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing* Experience with process monitoring software and equipment software (UNICORN, Pi Historian)* Creative thinker that can identify better and more efficient methods to address issues and gaps* Ability to handle more than one task at a time, while maintaining attention to detail and working in a fast-paced environment.* Strong analytical skills and attention to detail.* Ability to independently evaluate technical situations and propose potential solutions.* 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.Compensation Range: The base compensation range for this role is between $85,000 and $95,000. 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, #J-18808-Ljbffr
On-sitelocations:
Fremont, CAtime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R5072## 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
Sr Associate Scientist, Cell Culture will actively contribute to the develop and execute cell culture processes and technology transfer projects.
As part of the Cell Culture group, you will have opportunities to work on and take ownership of a wide-ranging set of projects for troubleshooting and investigations, system and workflow implementation, and tech transfers of processes into a GMP mulit-product 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 scope of responsibilities may include but are not limited to Document writing (SOPs, Equipment URSs, etc.), equipment validation execution support and single-use assembly design.**Essential Duties and Responsibilities:*** Executes complex unit operations including but not limited to media prep; cell culture thaw, expansion, and end of production banking; operation of single-use bioreactors, process monitoring and harvest operations.* Performs internal support activities such as maintenance of analytical equipment, stocking of consumables, discarding expired reagents, material coordination and weigh and dispense.* Maintains own training within compliance and trains other PD associates upon completion of trainer qualification.* Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation.* Author/review/approve technical documents such as tech transfer protocols and reports, experimental plans, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.* Documents work according to cGMP and cGDP.* Maintain cleanroom standards, practices, and housekeeping according to SOPs.* Recognize any minor issues from the equipment and any affiliated documentation and take appropriate corrective action within scope.
Notify supervisors and leads of issues and discrepancies immediately.* Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.* Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control.* Collaborate with other departments for raw materials, water, testing requirements, documentation, validation, maintenance, and scheduling* While performing duties of this job, the role requires walking, standing, stooping, kneeling, and crouching.
The employee must occasionally lift and or move up to 20 pounds independently.* Present during inspections from regulatory agencies and client audits as needed.**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 in Engineering, Life Sciences, or related discipline with 2-4 years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.* Must have bioreactor operations experience.* In-depth understanding of mammalian cell culture performance is required.* Hands-on experience in running, developing, and validating processes* Experience in process development, process characterization and/or tech. transfer processes.* Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing* Experience with process monitoring software and equipment software (UNICORN, Pi Historian)* Creative thinker that can identify better and more efficient methods to address issues and gaps* Ability to handle more than one task at a time, while maintaining attention to detail and working in a fast-paced environment.* Strong analytical skills and attention to detail.* Ability to independently evaluate technical situations and propose potential solutions.* 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.Compensation Range: The base compensation range for this role is between $85,000 and $95,000. 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, #J-18808-Ljbffr