Genezen Inc.
Scientist II/III - Upstream Process Development
Genezen Inc., Lexington, Massachusetts, United States, 02173
Scientist II/III - Upstream Process Development
Lexington, MAThe 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 GENEZENWe 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 SUMMARYThe Upstream Process Development Scientist will play a crucial role in developing and optimizing upstream processes for the production of Adeno-associated viruses (AAV), Lentiviral vectors (LVV), and Retroviral vectors (RVV) at Genezen. The ideal candidate will possess a strong background in cell culture and viral vector production, with specific expertise in the use of Bioreactors. This role will involve designing and executing experiments, analyzing data, and collaborating with cross-functional teams to deliver scalable and robust processes that meet client and regulatory requirements.This is a client-facing position that demands constant interaction and adherence to strict timelines. The individual must collaborate with cross-functional teams to establish and implement best regulatory and laboratory practices and lead the execution of complex experiments.ESSENTIAL JOB FUNCTIONSDevelop and optimize upstream processes for AAV, LVV, and RVV production, including cell culture, transfection, infection, and harvest.Scale-up processes from bench-scale to pilot and production scales, ensuring consistency and robustness.Design and conduct experiments to improve process yield, quality, and efficiency.Implement process characterization studies to understand critical process parameters.Responsible for monitoring and reporting on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality.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 clients, senior management, and team members.Maintain open communication via one-on-one and team meetings.Work closely with downstream processing, analytical development, quality control, and quality assurance teams to ensure seamless process transfer and integration.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.Stay current with the latest scientific and technological advancements in AAV production and upstream processing.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 EXPERIENCE4-5 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 Upstream process (Cell culture, Aseptic).Working knowledge of Upstream process (Transient transfection, PCL, single-use Bioreactor).Ability to interface successfully with multi-disciplined teams.Extremely detail-oriented with strong technical skills & mechanically inclined/knowledge of hand tools.PHYSICAL DEMANDSFrequently 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 Science: We 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 patients: We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.R esilience & Grit in operations: We are committed to overcoming challenges, learning from failures, and persistently striving for success.E xecute with Excellence & Integrity: We are dedicated to delivering quality results and upholding ethical principles.S olutions driven for our partners: We 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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Lexington, MAThe 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 GENEZENWe 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 SUMMARYThe Upstream Process Development Scientist will play a crucial role in developing and optimizing upstream processes for the production of Adeno-associated viruses (AAV), Lentiviral vectors (LVV), and Retroviral vectors (RVV) at Genezen. The ideal candidate will possess a strong background in cell culture and viral vector production, with specific expertise in the use of Bioreactors. This role will involve designing and executing experiments, analyzing data, and collaborating with cross-functional teams to deliver scalable and robust processes that meet client and regulatory requirements.This is a client-facing position that demands constant interaction and adherence to strict timelines. The individual must collaborate with cross-functional teams to establish and implement best regulatory and laboratory practices and lead the execution of complex experiments.ESSENTIAL JOB FUNCTIONSDevelop and optimize upstream processes for AAV, LVV, and RVV production, including cell culture, transfection, infection, and harvest.Scale-up processes from bench-scale to pilot and production scales, ensuring consistency and robustness.Design and conduct experiments to improve process yield, quality, and efficiency.Implement process characterization studies to understand critical process parameters.Responsible for monitoring and reporting on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality.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 clients, senior management, and team members.Maintain open communication via one-on-one and team meetings.Work closely with downstream processing, analytical development, quality control, and quality assurance teams to ensure seamless process transfer and integration.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.Stay current with the latest scientific and technological advancements in AAV production and upstream processing.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 EXPERIENCE4-5 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 Upstream process (Cell culture, Aseptic).Working knowledge of Upstream process (Transient transfection, PCL, single-use Bioreactor).Ability to interface successfully with multi-disciplined teams.Extremely detail-oriented with strong technical skills & mechanically inclined/knowledge of hand tools.PHYSICAL DEMANDSFrequently 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 Science: We 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 patients: We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.R esilience & Grit in operations: We are committed to overcoming challenges, learning from failures, and persistently striving for success.E xecute with Excellence & Integrity: We are dedicated to delivering quality results and upholding ethical principles.S olutions driven for our partners: We 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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