Tbwa Chiat/Day Inc
Sr. Scientist - Upstream Process Development
Tbwa Chiat/Day Inc, Lexington, Massachusetts, United States, 02173
Sr. Scientist - 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 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 SUMMARYThe Senior Scientist Upstream Process Development will be part of the Process Development Group reporting to the Director of Process Development. The Sr. Scientist Engineer is responsible for the Upstream Process development, characterization, technology transfer and GMP manufacturing technical support. This individual will lead or contribute as a core member of various cross-functional teams, and interact extensively with other departments within Genezen, including Analytical Development, Manufacturing, Engineering, and MSAT. This is also a client-facing position with regular interaction and external presentations.ESSENTIAL JOB FUNCTIONSProvides technical oversight and strategic input for upstream viral vector drug substance development activities.Leads, proposes, manages, and coordinates activities on platform improvement/continuous projects in USP labs.Leads, manages, and supports late-stage development, by identifying tasks, planning, monitoring progress of deliverables, and in terms of protocol and report generation in areas such as scale-down model qualification, process characterization, and scale-down model process validation studies.Leads and supports technology transfer activities at pilot plant and when necessary, performs experiments him/herself, focusing scale-up platform process at scale and process improvements implementation, process characterization at scale and bills of materials as well as sampling plans.Provides MSAT and manufacturing technical Upstream SME support for process troubleshooting, manufacturing data analysis, root cause analysis, and deviations during GMP production, change controls, CAPAs, CCRs and other Quality Systems documentation as needed.Designs and outlines experimental plans to meet the defined Genezen and client objectives. Analyzes and reviews experimental results and data. Performs, optimizes, and maintains linear scale-down models. Writes, reviews, and approves electronic lab notebooks (ELNs) entries, experimental protocols, development reports, process descriptions, and scientific reports.Presents project progress and results internally to cross-functional teams and externally to clients/stakeholders.Maintains robust communication with all relevant functions that have an impact on or are impacted by Upstream Process Development.Coordinates and supervises the activities in the USP labs (with a team of engineers/ (Jr.) bioprocess technologist, co-op students, interns, temporary personnel (contractors), and technical SMEs and when necessary, performs experiments him/herself. Guides junior USP team members by setting goals/tasks on projects.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 / LICENSESMSc with 8+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines.PhD with 4+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines.ON-THE-JOB EXPERIENCEProcess Development Experience.Cell Line Development Experience.Upstream Processing Experience with Cell Culture, Bioreactor Technologies, and Transfection/Infection approaches.SKILLS / ABILITIESHands-on experience on complex biologics, e.g. gene therapy, viral vaccines, therapeutic proteins.Experience with technology transfer and GMP manufacturing technical support.Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems.Effective communicator with track record of presenting data to relevant stakeholders.Experience with DoE design and statistical analysis on large data sets.Excellent scientific writing skills demonstrated by publications and reports.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 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 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 SUMMARYThe Senior Scientist Upstream Process Development will be part of the Process Development Group reporting to the Director of Process Development. The Sr. Scientist Engineer is responsible for the Upstream Process development, characterization, technology transfer and GMP manufacturing technical support. This individual will lead or contribute as a core member of various cross-functional teams, and interact extensively with other departments within Genezen, including Analytical Development, Manufacturing, Engineering, and MSAT. This is also a client-facing position with regular interaction and external presentations.ESSENTIAL JOB FUNCTIONSProvides technical oversight and strategic input for upstream viral vector drug substance development activities.Leads, proposes, manages, and coordinates activities on platform improvement/continuous projects in USP labs.Leads, manages, and supports late-stage development, by identifying tasks, planning, monitoring progress of deliverables, and in terms of protocol and report generation in areas such as scale-down model qualification, process characterization, and scale-down model process validation studies.Leads and supports technology transfer activities at pilot plant and when necessary, performs experiments him/herself, focusing scale-up platform process at scale and process improvements implementation, process characterization at scale and bills of materials as well as sampling plans.Provides MSAT and manufacturing technical Upstream SME support for process troubleshooting, manufacturing data analysis, root cause analysis, and deviations during GMP production, change controls, CAPAs, CCRs and other Quality Systems documentation as needed.Designs and outlines experimental plans to meet the defined Genezen and client objectives. Analyzes and reviews experimental results and data. Performs, optimizes, and maintains linear scale-down models. Writes, reviews, and approves electronic lab notebooks (ELNs) entries, experimental protocols, development reports, process descriptions, and scientific reports.Presents project progress and results internally to cross-functional teams and externally to clients/stakeholders.Maintains robust communication with all relevant functions that have an impact on or are impacted by Upstream Process Development.Coordinates and supervises the activities in the USP labs (with a team of engineers/ (Jr.) bioprocess technologist, co-op students, interns, temporary personnel (contractors), and technical SMEs and when necessary, performs experiments him/herself. Guides junior USP team members by setting goals/tasks on projects.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 / LICENSESMSc with 8+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines.PhD with 4+ years of relevant work experience in Bioprocess Engineering/ Life Science Biotechnology/Biochemistry/ Protein Chemistry, Chemical Engineering or related disciplines.ON-THE-JOB EXPERIENCEProcess Development Experience.Cell Line Development Experience.Upstream Processing Experience with Cell Culture, Bioreactor Technologies, and Transfection/Infection approaches.SKILLS / ABILITIESHands-on experience on complex biologics, e.g. gene therapy, viral vaccines, therapeutic proteins.Experience with technology transfer and GMP manufacturing technical support.Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems.Effective communicator with track record of presenting data to relevant stakeholders.Experience with DoE design and statistical analysis on large data sets.Excellent scientific writing skills demonstrated by publications and reports.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 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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