Bionova Scientific
Overview
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 multi-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
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. Benefits
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. EEO and Equal Opportunity
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
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology
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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 multi-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
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. Benefits
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. EEO and Equal Opportunity
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
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology
#J-18808-Ljbffr