Tbwa Chiat/Day Inc
Scientist II/III - Upstream Process Development
Tbwa Chiat/Day Inc, Indianapolis, Indiana, us, 46262
Scientist II/III - Upstream Process Development
Indianapolis, INThe field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.WORKING AT GENEZENMany people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.JOB SUMMARYDirect the development and establishment of processes in Process Development. This individual is accountable for developing a scalable platform for viral vector production processes that minimizes the risk during Process Development to GMP scale-up. The individual will provide technical expertise and leadership in science & technology and requires close collaboration with internal stakeholders at our Indiana site.ESSENTIAL JOB FUNCTIONSBe accountable for establishing the platform from small scale through intermediate scale (50L) lentiviral and retroviral vector processes.Responsible for monitoring and reporting on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality.Develop and support process optimization efforts to increase process robustness, reduce costs, and improve viral yield and purity.Design and execute experiments independently: accurately record, analyze, and communicate data to senior management and team members.Maintain open communication via one-on-one and team meetings.Stay current with relevant technologies and need to be adept at identifying new approaches.Perform and lead single-use system design manifold, selection, implementation, configurations in between Upstream bioreactor and downstream unit operations and control strategies.Develop proper SOP/SSP for Upstream processes.Responsible for the process transfer from or to clients and to in-house manufacturing plant.Maintain external technical relationships and collaborate with equipment and material suppliers.Serve as process SME for regulatory and client audits.Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the assigned functional area.SPECIAL JOB REQUIREMENTSAdaptability required as work schedule may change based on business needs.Criminal background check required.Other duties as assigned.KNOWLEDGE, SKILLS AND EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESBS, MS, or PhD in biological engineering.ON-THE-JOB EXPERIENCE5-8 years of relevant industry experience. Solid foundation in the fundamentals of biochemical engineering, virology and cell biology. Entrepreneurial experience dealing with customers in product development. Pharmaceutical industry experience in technical support of cGMP manufacturing and/or process development, including experience with Contract Development and Manufacturing Organizations. Experience with cell culture technologies, molecular biology, upstream processing, and aseptic processing.SKILLS / ABILITIESWorking knowledge of cGMPs related to the production of viral therapeutics. Ability to interface successfully with multi-disciplined teams. Extremely detail-oriented with strong technical skills & mechanically inclined/knowledge of hand tools.PHYSICAL DEMANDSWhile performing the duties of this job, the employee is required to meet the following physical demands:Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock.Occasionally exposed to extremely loud noise levels.Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required.MovementFrequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms.Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.LiftingFrequently lift and/or move up to 10 pounds.Occasionally lift and/or move up to 25 pounds.VisionFrequently utilize close vision and the ability to adjust focus.CommunicationFrequently required to communicate by talking, hearing, using telephone and e-mail.GENEZEN'S CURES VALUE-BASED COMPETENCIESC ommitted to ScienceWe are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.U rgency in action for the patientsWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.R esilience & Grit in operationsWe are committed to overcoming challenges, learning from failures, and persistently striving for success.E xecute with Excellence & IntegrityWe are dedicated to delivering quality results and upholding ethical principles.S olutions driven for our partnersWe are committed to being a proactive, collaborative, creative and open-minded partner.GENEZEN'S BENEFITSPaid vacation days, amount based on tenure.401(k) plan with company match up to 6% of salary, vested immediately.Choice of several healthcare plans.FSA and HSA programs.Employer-paid basic term life/personal accident insurance.Voluntary disability, universal life/personal accident insurance.ADDITIONAL DETAILSNothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.This position requires a criminal background check.Genezen is an Equal Opportunity Employer.Genezen participates in EVerify.Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
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Indianapolis, INThe field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.WORKING AT GENEZENMany people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.JOB SUMMARYDirect the development and establishment of processes in Process Development. This individual is accountable for developing a scalable platform for viral vector production processes that minimizes the risk during Process Development to GMP scale-up. The individual will provide technical expertise and leadership in science & technology and requires close collaboration with internal stakeholders at our Indiana site.ESSENTIAL JOB FUNCTIONSBe accountable for establishing the platform from small scale through intermediate scale (50L) lentiviral and retroviral vector processes.Responsible for monitoring and reporting on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality.Develop and support process optimization efforts to increase process robustness, reduce costs, and improve viral yield and purity.Design and execute experiments independently: accurately record, analyze, and communicate data to senior management and team members.Maintain open communication via one-on-one and team meetings.Stay current with relevant technologies and need to be adept at identifying new approaches.Perform and lead single-use system design manifold, selection, implementation, configurations in between Upstream bioreactor and downstream unit operations and control strategies.Develop proper SOP/SSP for Upstream processes.Responsible for the process transfer from or to clients and to in-house manufacturing plant.Maintain external technical relationships and collaborate with equipment and material suppliers.Serve as process SME for regulatory and client audits.Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the assigned functional area.SPECIAL JOB REQUIREMENTSAdaptability required as work schedule may change based on business needs.Criminal background check required.Other duties as assigned.KNOWLEDGE, SKILLS AND EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESBS, MS, or PhD in biological engineering.ON-THE-JOB EXPERIENCE5-8 years of relevant industry experience. Solid foundation in the fundamentals of biochemical engineering, virology and cell biology. Entrepreneurial experience dealing with customers in product development. Pharmaceutical industry experience in technical support of cGMP manufacturing and/or process development, including experience with Contract Development and Manufacturing Organizations. Experience with cell culture technologies, molecular biology, upstream processing, and aseptic processing.SKILLS / ABILITIESWorking knowledge of cGMPs related to the production of viral therapeutics. Ability to interface successfully with multi-disciplined teams. Extremely detail-oriented with strong technical skills & mechanically inclined/knowledge of hand tools.PHYSICAL DEMANDSWhile performing the duties of this job, the employee is required to meet the following physical demands:Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock.Occasionally exposed to extremely loud noise levels.Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required.MovementFrequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms.Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.LiftingFrequently lift and/or move up to 10 pounds.Occasionally lift and/or move up to 25 pounds.VisionFrequently utilize close vision and the ability to adjust focus.CommunicationFrequently required to communicate by talking, hearing, using telephone and e-mail.GENEZEN'S CURES VALUE-BASED COMPETENCIESC ommitted to ScienceWe are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.U rgency in action for the patientsWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.R esilience & Grit in operationsWe are committed to overcoming challenges, learning from failures, and persistently striving for success.E xecute with Excellence & IntegrityWe are dedicated to delivering quality results and upholding ethical principles.S olutions driven for our partnersWe are committed to being a proactive, collaborative, creative and open-minded partner.GENEZEN'S BENEFITSPaid vacation days, amount based on tenure.401(k) plan with company match up to 6% of salary, vested immediately.Choice of several healthcare plans.FSA and HSA programs.Employer-paid basic term life/personal accident insurance.Voluntary disability, universal life/personal accident insurance.ADDITIONAL DETAILSNothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.This position requires a criminal background check.Genezen is an Equal Opportunity Employer.Genezen participates in EVerify.Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
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