Genezen Inc.
Scientist II/III - Downstream Process Development
Genezen Inc., Lexington, Massachusetts, United States, 02173
Scientist II/III - Downstream 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 GENEZENGenezen 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.JOB SUMMARYThe Downstream Process Development Scientist will be responsible for developing and optimizing purification processes for Adeno-associated viruses (AAV), Lentiviral vectors (LVV) and Retroviral Vectors (RVV) at Genezen Lexington, MA facility. The ideal candidate will have extensive experience in downstream processing, including chromatography, Tangential flow filtration, and formulation techniques. This role involves designing and executing experiments, analyzing data, and collaborating with cross-functional teams to establish scalable and robust downstream processes that meet both client and regulatory requirements.This is a client-facing position that demands constant interaction and adherence to strict timelines.ESSENTIAL JOB FUNCTIONSDevelop and optimize downstream processes for AAV purification, including clarification, chromatography, filtration, and formulation.Scale-up processes from bench-scale to pilot and production scales up to 2000L.Monitor and report on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality.Conduct process characterization studies to identify and control critical process parameters.Support the commercial function in the assessment of new opportunities and provide appropriate technical input to prospective customers.Design and execute experiments independently, accurately record, analyze, and communicate data.Maintain open communication via one-on-one and team meetings.Stay current with relevant technologies and identify new approaches.Perform and lead single-use system design, selection, implementation, and control strategies.Collaborate closely with upstream processing, analytical development, quality control, and quality assurance teams.Maintain external technical relationships and collaborate with equipment and material suppliers.Propose and implement innovative solutions to enhance process efficiency, product purity, and yield.Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures.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 biochemical engineering, virology, and cell biology.SKILLS / ABILITIESWorking knowledge of Downstream process and AKTA chromatography and tangential flow filtration. Ability to interface successfully with multi-disciplined teams.PHYSICAL DEMANDSFrequently required to work in a BSL 2 environment with personal protective equipment.Regularly required to work around large machinery.Occasionally exposed to moving mechanical parts and hazardous materials.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.Employer-paid basic term life/personal accident insurance.ADDITIONAL DETAILSThis position requires a criminal background check.Genezen is an Equal Opportunity Employer.
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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 GENEZENGenezen 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.JOB SUMMARYThe Downstream Process Development Scientist will be responsible for developing and optimizing purification processes for Adeno-associated viruses (AAV), Lentiviral vectors (LVV) and Retroviral Vectors (RVV) at Genezen Lexington, MA facility. The ideal candidate will have extensive experience in downstream processing, including chromatography, Tangential flow filtration, and formulation techniques. This role involves designing and executing experiments, analyzing data, and collaborating with cross-functional teams to establish scalable and robust downstream processes that meet both client and regulatory requirements.This is a client-facing position that demands constant interaction and adherence to strict timelines.ESSENTIAL JOB FUNCTIONSDevelop and optimize downstream processes for AAV purification, including clarification, chromatography, filtration, and formulation.Scale-up processes from bench-scale to pilot and production scales up to 2000L.Monitor and report on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality.Conduct process characterization studies to identify and control critical process parameters.Support the commercial function in the assessment of new opportunities and provide appropriate technical input to prospective customers.Design and execute experiments independently, accurately record, analyze, and communicate data.Maintain open communication via one-on-one and team meetings.Stay current with relevant technologies and identify new approaches.Perform and lead single-use system design, selection, implementation, and control strategies.Collaborate closely with upstream processing, analytical development, quality control, and quality assurance teams.Maintain external technical relationships and collaborate with equipment and material suppliers.Propose and implement innovative solutions to enhance process efficiency, product purity, and yield.Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures.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 biochemical engineering, virology, and cell biology.SKILLS / ABILITIESWorking knowledge of Downstream process and AKTA chromatography and tangential flow filtration. Ability to interface successfully with multi-disciplined teams.PHYSICAL DEMANDSFrequently required to work in a BSL 2 environment with personal protective equipment.Regularly required to work around large machinery.Occasionally exposed to moving mechanical parts and hazardous materials.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.Employer-paid basic term life/personal accident insurance.ADDITIONAL DETAILSThis position requires a criminal background check.Genezen is an Equal Opportunity Employer.
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