George Washington University
Washington, Washington DC
I. JOB OVERVIEW Job Description Summary: The Director, Regulatory Oversight position reports to the Associate Provost Research Integrity and Compliance (AP-RIC) and is responsible for leading the administrative, regulatory, and programmatic activities supporting the university's Human Research Protection Program (HRPP), animal care and use program, and oversight committees for the use of recombinant DNA and biohazardous materials, and research involving human embryonic and/or pluripotent stem cells. The Director is also responsible for administrative oversight of the research radiation and laser safety programs. The Director, Regulatory Oversight works closely with Office of Research Integrity and Compliance leadership, the Office of Clinical Research (OCR) staff, Environmental Health and Safety, Office of General Counsel, regulatory committee Chairs and members, the Attending Veterinarian, and others in the GW research community to ensure operational efficiency and compliance with laws, regulations, standards, and institutional requirements that impact the research enterprise. In the performance of duties, the position will review, research, and interpret changes, trends and new developments related to areas of oversight; provide written analysis on specified topics; draft policies and procedures to implement and operationalize related initiatives; ensure regulatory review processes are standardized; develop strategies to enable implicated research departments and personnel to successfully adapt to changes; serve as a resource to the GW community regarding research matters in areas of oversight; maintain staff productivity; and resolve compliance, service and operational issues. The Director, Regulatory Oversight position responsibilities include overseeing the activities of the department staff, ensuring quality, productivity, functional excellence and efficiency to accomplish strategic and operational objectives. In addition, this position is accountable for employee engagement, adequate staffing levels, budget development and compliance, staffing decisions such as hiring and terminating employment, coaching and counseling employees on work related performance, and developing and implementing policies and procedures to ensure a safe and effective work environment. This position also ensures training, monitoring and operations initiatives are implemented which secure compliance with ethical and legal business practices and accreditation/regulatory/government regulations. Responsibilities Provides strategic leadership and operational direction to the Office of Human Research (OHR) and Office of Research Safety (ORS) teams; Oversees the administrative, regulatory, and programmatic activities of the Institutional Review Boards (IRB); Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC), Stem Cell Research Oversight Committee (SCRO), and Laser safety program; Serves as Human Protections Administrator (HPA) on GW's Federal Wide Assurance (FWA); Ensures a thorough review of research protocols prior to submission to the regulatory committees for review. Ensures administrative teams are appropriately trained to provide comments to the applicable regulatory committees for consideration with submissions to assure that the review is conducted according to regulations and guidance; Facilitates maintenance of AAALAC accreditation; supports and oversees AAHRPP accreditation; Directs semi-annual facility inspections and program reviews. Serves as a key contact in communications with regulatory agencies and accrediting bodies. In collaboration with the Executive Director, Research Integrity and Compliance, leads external agency inspections and audits; provides support for audits and inspections to investigators, administrative teams and regulatory committees (i.e. IRB, IACUC). Reviews agency reporting letters, communications with regulatory authorities, and assists with responses to internal and external investigations, audits and other matters. Communicates with federal and accrediting oversight authorities and carries out annual reporting requirements; In collaboration with the Executive Director for Research Integrity and Compliance, oversees quality assurance and quality improvement initiatives, including post-approval monitoring of animal research protocols; Directs biological and radiation safety during emergencies and planned special events at the university; Coordinates with Environmental Health and Safety to manage oversight of the EHS Research Specialist, and EHS/occupational health-related matters for the research program; Directs, develops and implements strategic and operational/high level projects and processes either through independent/highly autonomous work or through the facilitation of work teams to enable the effective and efficient completion of objectives; Oversees management of and ensures development for staff to meet overall objectives in terms of quality, service and cost effectiveness. Provides timely guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem. Directs management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees; Provides leadership and communication to maintain a competent and engaged employee group by conducting regular department meetings to review policies and procedures and operational matters, rounding on all employees, completing performance appraisals, conducting new hire feedback sessions, coaching/corrective counseling, and providing recognition/commendations to achieve desired outcomes; Identifies opportunities and takes action to build strategic relationships between areas of oversight, teams, schools & departments to achieve business goals. Drives the promotion of teamwork within and between schools/departments; participates and/or leads and facilitates department process improvements as needed; Provides expert regulatory guidance to researchers, staff, committee members, and leadership and partners internal and external to the organization. Serves as liaison between researchers & research teams, department management, committees & leadership related to areas of expertise; Works with relevant GW offices to establish office web pages, newsletters, marketing pamphlets, and other tools (educational content in areas of oversight, etc); In collaboration with the Executive Director for Research Integrity and Compliance, develops, delivers, and maintains education and outreach programming for the committees and the research community in areas of oversight to ensure compliance. Oversees administrative management of protocols, ensuring staff alignment with requisite expertise; ensuring appropriate staff coverage for regulatory operations; Develops and maintains and enforces safety standards, policies, and standard operating procedures; Ensures a safe and effective working environment; monitors and/or revises the department safety plan and/or any specific accreditation/regulatory required safety guidelines. Responsible for staff maintenance of credentials and competencies, per accrediting/ licensing agency and/or department guidelines as applicable; Develops policies and procedures to ensure biosafety and radiation safety certifications are maintained by all relevant stakeholders;, decontaminations and moves are implemented safely and in accordance with regulatory requirements. Employs a proactive approach in the optimization of safe and high-quality outcomes and information systems by monitoring and improving the department workflow and enhancing operations, using peer-to-peer accountability and identifying solutions via collaboration. Implements process improvements utilizing tools such as lean principles. Role models situational awareness, using teachable moments to improve safety and quality. Performs other work-related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position. Minimum Qualifications: Qualified candidates will hold a Bachelor's degree in an appropriate area of specialization plus 8 years of relevant professional experience, or, a Master's degree or higher in a relevant area of study plus 6 years of relevant professional experience. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience. Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications: Preferred Qualifications: Master's degree in the biological sciences or related discipline. Managerial experience is highly desirable. Thorough knowledge of federal regulations and guidelines related to the oversight of laboratory animal research and use of biohazardous materials in research. CIP CPIA credentialed or qualified to earn the designation within one year of employment. Ability to plan, organize and carry out responsibilities independently. Ability to set priorities, meet deadlines and manage multiple projects. Ability to interpret policies and procedures to solve unusual and/or difficult problems. Strong interpersonal skills and the ability to effectively communicate with university administrators, faculty, post-docs, and students in a collegial manner. Demonstrated written communication skills. Exceptional attention to detail. . click apply for full job details
03/26/2024
Full time
I. JOB OVERVIEW Job Description Summary: The Director, Regulatory Oversight position reports to the Associate Provost Research Integrity and Compliance (AP-RIC) and is responsible for leading the administrative, regulatory, and programmatic activities supporting the university's Human Research Protection Program (HRPP), animal care and use program, and oversight committees for the use of recombinant DNA and biohazardous materials, and research involving human embryonic and/or pluripotent stem cells. The Director is also responsible for administrative oversight of the research radiation and laser safety programs. The Director, Regulatory Oversight works closely with Office of Research Integrity and Compliance leadership, the Office of Clinical Research (OCR) staff, Environmental Health and Safety, Office of General Counsel, regulatory committee Chairs and members, the Attending Veterinarian, and others in the GW research community to ensure operational efficiency and compliance with laws, regulations, standards, and institutional requirements that impact the research enterprise. In the performance of duties, the position will review, research, and interpret changes, trends and new developments related to areas of oversight; provide written analysis on specified topics; draft policies and procedures to implement and operationalize related initiatives; ensure regulatory review processes are standardized; develop strategies to enable implicated research departments and personnel to successfully adapt to changes; serve as a resource to the GW community regarding research matters in areas of oversight; maintain staff productivity; and resolve compliance, service and operational issues. The Director, Regulatory Oversight position responsibilities include overseeing the activities of the department staff, ensuring quality, productivity, functional excellence and efficiency to accomplish strategic and operational objectives. In addition, this position is accountable for employee engagement, adequate staffing levels, budget development and compliance, staffing decisions such as hiring and terminating employment, coaching and counseling employees on work related performance, and developing and implementing policies and procedures to ensure a safe and effective work environment. This position also ensures training, monitoring and operations initiatives are implemented which secure compliance with ethical and legal business practices and accreditation/regulatory/government regulations. Responsibilities Provides strategic leadership and operational direction to the Office of Human Research (OHR) and Office of Research Safety (ORS) teams; Oversees the administrative, regulatory, and programmatic activities of the Institutional Review Boards (IRB); Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC), Stem Cell Research Oversight Committee (SCRO), and Laser safety program; Serves as Human Protections Administrator (HPA) on GW's Federal Wide Assurance (FWA); Ensures a thorough review of research protocols prior to submission to the regulatory committees for review. Ensures administrative teams are appropriately trained to provide comments to the applicable regulatory committees for consideration with submissions to assure that the review is conducted according to regulations and guidance; Facilitates maintenance of AAALAC accreditation; supports and oversees AAHRPP accreditation; Directs semi-annual facility inspections and program reviews. Serves as a key contact in communications with regulatory agencies and accrediting bodies. In collaboration with the Executive Director, Research Integrity and Compliance, leads external agency inspections and audits; provides support for audits and inspections to investigators, administrative teams and regulatory committees (i.e. IRB, IACUC). Reviews agency reporting letters, communications with regulatory authorities, and assists with responses to internal and external investigations, audits and other matters. Communicates with federal and accrediting oversight authorities and carries out annual reporting requirements; In collaboration with the Executive Director for Research Integrity and Compliance, oversees quality assurance and quality improvement initiatives, including post-approval monitoring of animal research protocols; Directs biological and radiation safety during emergencies and planned special events at the university; Coordinates with Environmental Health and Safety to manage oversight of the EHS Research Specialist, and EHS/occupational health-related matters for the research program; Directs, develops and implements strategic and operational/high level projects and processes either through independent/highly autonomous work or through the facilitation of work teams to enable the effective and efficient completion of objectives; Oversees management of and ensures development for staff to meet overall objectives in terms of quality, service and cost effectiveness. Provides timely guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem. Directs management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees; Provides leadership and communication to maintain a competent and engaged employee group by conducting regular department meetings to review policies and procedures and operational matters, rounding on all employees, completing performance appraisals, conducting new hire feedback sessions, coaching/corrective counseling, and providing recognition/commendations to achieve desired outcomes; Identifies opportunities and takes action to build strategic relationships between areas of oversight, teams, schools & departments to achieve business goals. Drives the promotion of teamwork within and between schools/departments; participates and/or leads and facilitates department process improvements as needed; Provides expert regulatory guidance to researchers, staff, committee members, and leadership and partners internal and external to the organization. Serves as liaison between researchers & research teams, department management, committees & leadership related to areas of expertise; Works with relevant GW offices to establish office web pages, newsletters, marketing pamphlets, and other tools (educational content in areas of oversight, etc); In collaboration with the Executive Director for Research Integrity and Compliance, develops, delivers, and maintains education and outreach programming for the committees and the research community in areas of oversight to ensure compliance. Oversees administrative management of protocols, ensuring staff alignment with requisite expertise; ensuring appropriate staff coverage for regulatory operations; Develops and maintains and enforces safety standards, policies, and standard operating procedures; Ensures a safe and effective working environment; monitors and/or revises the department safety plan and/or any specific accreditation/regulatory required safety guidelines. Responsible for staff maintenance of credentials and competencies, per accrediting/ licensing agency and/or department guidelines as applicable; Develops policies and procedures to ensure biosafety and radiation safety certifications are maintained by all relevant stakeholders;, decontaminations and moves are implemented safely and in accordance with regulatory requirements. Employs a proactive approach in the optimization of safe and high-quality outcomes and information systems by monitoring and improving the department workflow and enhancing operations, using peer-to-peer accountability and identifying solutions via collaboration. Implements process improvements utilizing tools such as lean principles. Role models situational awareness, using teachable moments to improve safety and quality. Performs other work-related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position. Minimum Qualifications: Qualified candidates will hold a Bachelor's degree in an appropriate area of specialization plus 8 years of relevant professional experience, or, a Master's degree or higher in a relevant area of study plus 6 years of relevant professional experience. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience. Additional Required Licenses/Certifications/Posting Specific Minimum Qualifications: Preferred Qualifications: Master's degree in the biological sciences or related discipline. Managerial experience is highly desirable. Thorough knowledge of federal regulations and guidelines related to the oversight of laboratory animal research and use of biohazardous materials in research. CIP CPIA credentialed or qualified to earn the designation within one year of employment. Ability to plan, organize and carry out responsibilities independently. Ability to set priorities, meet deadlines and manage multiple projects. Ability to interpret policies and procedures to solve unusual and/or difficult problems. Strong interpersonal skills and the ability to effectively communicate with university administrators, faculty, post-docs, and students in a collegial manner. Demonstrated written communication skills. Exceptional attention to detail. . click apply for full job details
Obsidian Therapeutics is pioneering controllable cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. Obsidian's programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Our Opportunity… We're looking for a highly motivated scientist with a strong background in process development to contribute to building Vector Process Development capabilities for Obsidian to drive the development of the engineered cell therapy products in our pipeline targeting cancer. In this role, you'll work with the Manufacturing, Cell Therapy Process Development, Analytical Development, Regulatory, and Quality functions to develop gene delivery processes to support Obsidian's engineered cell therapy clinical pipeline. As part of our Technical Development and Manufacturing department, you will be a vital part of a highly collaborative team working to achieve Obsidian's vision by translating innovative science into medical breakthroughs for patients. This is a unique opportunity in a well-funded early-stage company with blue-chip investors, field-leading advisors, and a highly experienced team. You will help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. Located in the heart of Cambridge, we're proud of our diversely talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. We offer competitive salary and benefits, and potential for employee ownership through stock options. You Will… Apply your expertise in the development of processes for viral vector production to support engineered cell therapies. Assist with developing scalable and efficient viral vector production processes and materials for engineered cell therapies. Design, plan, and execute experiments in Vector Process Development, working both independently and as part of a multidisciplinary team of researchers Identify and implement solutions to address current technical challenges in viral vector (eg lentiviral and retroviral) production processes in collaboration with research to support engineered cell therapies Run and/or improve methods in collaboration with research and analytical development to characterize viral vector production methods and primary cell transduction Supply viral vector materials to support research studies, analytical development, and CDMO tech transfer activities Interpret results, troubleshoot technical hurdles, and propose solutions to the team Maintain excellent records of experiments, including Electronic Notebook entries, authoring of protocols, test methods, and study reports Collaborate effectively across the Obsidian organization, present internally to project teams, management, and scientific teams Maintain a safe work environment in accordance with policies/procedures/regulations You Bring… Core Qualifications BS or MS in a relevant discipline (eg chemical engineering, cellular and molecular biology, biotechnology) Minimum of 6-10 years relevant industry experience including prior direct experience in viral vector biology and/or production Demonstrated track record with different gene delivery methodologies, such as lentivirus/ retrovirus/ AAV supporting early-stage research and development of biologics Subject matter expertise in mammalian cell culture, including adherent and suspension cell culture scale-up/down and stable cell line development Subject matter expertise in viral vector production, including downstream purification and concentration methods (eg Tangential Flow Filtration) Familiar with product characterization methods relevant to viral vectors (e.g. cell line/primary cell transduction, titering, flow cytometry, qPCR/ ddPCR, ELISA, MSD, and western blot) Strong troubleshooting and communication skills Highly organized with strong record-keeping skills, and an ability to manage multiple tasks in parallel Highly collaborative working style Ability to work independently and as part of teams to meet deadlines in a fast-paced rapidly developing environment, prioritize work across multiple projects, and adapt to changes in order to fulfill our mission Bonus Qualifications Experience in process development supporting early and/ or late-stage development of biologics is highly desirable (cell therapy, gene therapy, vaccines, antibodies) Experience with Design of Experiment (DOE) approaches and application to process improvement Experience in technical transfer of processes to CDMOs Familiarity with FDA and EMA guidance documents relevant to gene and cell therapy is a plus
03/23/2021
Full time
Obsidian Therapeutics is pioneering controllable cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. Obsidian's programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Our Opportunity… We're looking for a highly motivated scientist with a strong background in process development to contribute to building Vector Process Development capabilities for Obsidian to drive the development of the engineered cell therapy products in our pipeline targeting cancer. In this role, you'll work with the Manufacturing, Cell Therapy Process Development, Analytical Development, Regulatory, and Quality functions to develop gene delivery processes to support Obsidian's engineered cell therapy clinical pipeline. As part of our Technical Development and Manufacturing department, you will be a vital part of a highly collaborative team working to achieve Obsidian's vision by translating innovative science into medical breakthroughs for patients. This is a unique opportunity in a well-funded early-stage company with blue-chip investors, field-leading advisors, and a highly experienced team. You will help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. Located in the heart of Cambridge, we're proud of our diversely talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. We offer competitive salary and benefits, and potential for employee ownership through stock options. You Will… Apply your expertise in the development of processes for viral vector production to support engineered cell therapies. Assist with developing scalable and efficient viral vector production processes and materials for engineered cell therapies. Design, plan, and execute experiments in Vector Process Development, working both independently and as part of a multidisciplinary team of researchers Identify and implement solutions to address current technical challenges in viral vector (eg lentiviral and retroviral) production processes in collaboration with research to support engineered cell therapies Run and/or improve methods in collaboration with research and analytical development to characterize viral vector production methods and primary cell transduction Supply viral vector materials to support research studies, analytical development, and CDMO tech transfer activities Interpret results, troubleshoot technical hurdles, and propose solutions to the team Maintain excellent records of experiments, including Electronic Notebook entries, authoring of protocols, test methods, and study reports Collaborate effectively across the Obsidian organization, present internally to project teams, management, and scientific teams Maintain a safe work environment in accordance with policies/procedures/regulations You Bring… Core Qualifications BS or MS in a relevant discipline (eg chemical engineering, cellular and molecular biology, biotechnology) Minimum of 6-10 years relevant industry experience including prior direct experience in viral vector biology and/or production Demonstrated track record with different gene delivery methodologies, such as lentivirus/ retrovirus/ AAV supporting early-stage research and development of biologics Subject matter expertise in mammalian cell culture, including adherent and suspension cell culture scale-up/down and stable cell line development Subject matter expertise in viral vector production, including downstream purification and concentration methods (eg Tangential Flow Filtration) Familiar with product characterization methods relevant to viral vectors (e.g. cell line/primary cell transduction, titering, flow cytometry, qPCR/ ddPCR, ELISA, MSD, and western blot) Strong troubleshooting and communication skills Highly organized with strong record-keeping skills, and an ability to manage multiple tasks in parallel Highly collaborative working style Ability to work independently and as part of teams to meet deadlines in a fast-paced rapidly developing environment, prioritize work across multiple projects, and adapt to changes in order to fulfill our mission Bonus Qualifications Experience in process development supporting early and/ or late-stage development of biologics is highly desirable (cell therapy, gene therapy, vaccines, antibodies) Experience with Design of Experiment (DOE) approaches and application to process improvement Experience in technical transfer of processes to CDMOs Familiarity with FDA and EMA guidance documents relevant to gene and cell therapy is a plus
Obsidian Therapeutics is pioneering controllable cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. Obsidian's programs apply our CytoDrive TM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Our Opportunity… We're looking for a scientist with a strong background in analytical development to contribute to building Obsidian's analytical sciences capabilities for process and product characterization, contributing to the first autologous cell therapy product in our pipeline targeting cancer. In this role, you'll work collaboratively with the Manufacturing, Process Development, Regulatory, and Quality functions to develop analytical tools for the characterization of viral vectors and cell therapy products to support our clinical pipeline. As part of our Technical Development and Manufacturing department, you'll be a vital part of a highly collaborative team working to achieve Obsidian's vision by translating innovative science into medical breakthroughs for patients. This is a unique opportunity in a well-funded early-stage company with blue chip investors, field-leading advisors, and a highly experienced team. You will help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. Located in the heart of Cambridge, we're proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. We offer competitive salary and benefits, and potential for employee ownership through stock options. Apply to . You Will… Apply your expertise in developing and qualifying analytical assays to support the release and characterization of viral vector and cell therapy products in early and later phases of development Design, plan, and execute experiments in Analytical Development, working both independently and as part of a multidisciplinary team of researchers Support development and/or improvement of methods in collaboration with research and vector process development to characterize viral vector production methods and primary cell transduction (eg T cell, TIL, NK cell) Support introduction of new analytical technologies, implementation of common reagents and controls, trending of data, and protocols to support construct screening, research studies, research vector production, and CDMO tech transfer activities Interpret results, troubleshoot technical hurdles, and propose solutions to the team Maintain excellent records of experiments, including Electronic Notebook entries, authoring of protocols, test methods, and study reports Collaborate effectively across Obsidian organization, present internally to project teams, management, and scientific teams You Bring… Core Qualifications BS or MS in a relevant discipline (molecular biology, cell biology, biomolecular engineering, biotechnology or relevant field) Minimum of 6-10 years relevant industry experience including prior direct experience with analysis of viral vectors and/or cell therapies Demonstrated track record with analytical techniques focused on cell biology, immunology, molecular biology, and potency assay development Subject matter expertise in analytical development, including methods such as multicolor flow cytometry/ FACS , cell line/ primary cell transduction/ transfection, , qPCR/ ddPCR, ELISA, MSD, and western blot Strong troubleshooting and communication skills. Highly organized with strong record keeping and an ability to manage multiple tasks in parallel Highly collaborative working style and ability to adapt in a fast paced, rapidly developing environment Ability to work with general direction to meet objectives and timelines, adapting to changes and priorities in order to fulfill our mission Bonus Qualifications Experience with development of flow cytometry-based assays for release and characterization Experience in analytical development supporting early and/ or late stage development of biologics is highly desirable (cell therapy, gene therapy, vaccines, antibodies) Demonstrated track record with analytical development and method qualification for characterization of engineered cell therapies Familiarity with viral vector production and cell line engineering Experience with Design of Experiment (DOE) approaches and application to analytical development Experience working with CDMOs/ CTLs for method transfer/ development/ qualification/ validation Familiarity with FDA and EMA guidance documents relevant to gene and cell therapy analytical development and method validation
03/23/2021
Full time
Obsidian Therapeutics is pioneering controllable cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. Obsidian's programs apply our CytoDrive TM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Our Opportunity… We're looking for a scientist with a strong background in analytical development to contribute to building Obsidian's analytical sciences capabilities for process and product characterization, contributing to the first autologous cell therapy product in our pipeline targeting cancer. In this role, you'll work collaboratively with the Manufacturing, Process Development, Regulatory, and Quality functions to develop analytical tools for the characterization of viral vectors and cell therapy products to support our clinical pipeline. As part of our Technical Development and Manufacturing department, you'll be a vital part of a highly collaborative team working to achieve Obsidian's vision by translating innovative science into medical breakthroughs for patients. This is a unique opportunity in a well-funded early-stage company with blue chip investors, field-leading advisors, and a highly experienced team. You will help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. Located in the heart of Cambridge, we're proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. We offer competitive salary and benefits, and potential for employee ownership through stock options. Apply to . You Will… Apply your expertise in developing and qualifying analytical assays to support the release and characterization of viral vector and cell therapy products in early and later phases of development Design, plan, and execute experiments in Analytical Development, working both independently and as part of a multidisciplinary team of researchers Support development and/or improvement of methods in collaboration with research and vector process development to characterize viral vector production methods and primary cell transduction (eg T cell, TIL, NK cell) Support introduction of new analytical technologies, implementation of common reagents and controls, trending of data, and protocols to support construct screening, research studies, research vector production, and CDMO tech transfer activities Interpret results, troubleshoot technical hurdles, and propose solutions to the team Maintain excellent records of experiments, including Electronic Notebook entries, authoring of protocols, test methods, and study reports Collaborate effectively across Obsidian organization, present internally to project teams, management, and scientific teams You Bring… Core Qualifications BS or MS in a relevant discipline (molecular biology, cell biology, biomolecular engineering, biotechnology or relevant field) Minimum of 6-10 years relevant industry experience including prior direct experience with analysis of viral vectors and/or cell therapies Demonstrated track record with analytical techniques focused on cell biology, immunology, molecular biology, and potency assay development Subject matter expertise in analytical development, including methods such as multicolor flow cytometry/ FACS , cell line/ primary cell transduction/ transfection, , qPCR/ ddPCR, ELISA, MSD, and western blot Strong troubleshooting and communication skills. Highly organized with strong record keeping and an ability to manage multiple tasks in parallel Highly collaborative working style and ability to adapt in a fast paced, rapidly developing environment Ability to work with general direction to meet objectives and timelines, adapting to changes and priorities in order to fulfill our mission Bonus Qualifications Experience with development of flow cytometry-based assays for release and characterization Experience in analytical development supporting early and/ or late stage development of biologics is highly desirable (cell therapy, gene therapy, vaccines, antibodies) Demonstrated track record with analytical development and method qualification for characterization of engineered cell therapies Familiarity with viral vector production and cell line engineering Experience with Design of Experiment (DOE) approaches and application to analytical development Experience working with CDMOs/ CTLs for method transfer/ development/ qualification/ validation Familiarity with FDA and EMA guidance documents relevant to gene and cell therapy analytical development and method validation
LyondellBasell (NYSE: LYB) is one of the largest plastics, chemicals and refining companies in the world. Driven by its employees around the globe, LyondellBasell produces materials and products that are key to advancing solutions to modern challenges like enhancing food safety through lightweight and flexible packaging, protecting the purity of water supplies through stronger and more versatile pipes, improving the safety, comfort and fuel efficiency of many of the cars and trucks on the road, and ensuring the safe and effective functionality in electronics and appliances. LyondellBasell sells products into more than 100 countries and is the world's largest producer of polypropylene compounds and the largest licensor of polyolefin technologies. In 2020, LyondellBasell was named to Fortune Magazine's list of the 'World's Most Admired Companies' for the third consecutive year. Basic Function The R&D Technician will be responsible for laboratory and pilot scale unit based research and development (R&D) tasks, including running experiments, sampling, testing, measuring, recording and analyzing results to meet Chemicals R&D project goals. Roles & Responsibilities Setting up, modifying, trouble-shooting and running bench-scale laboratory equipment and operating pilot-scale units. Observing and recording laboratory and pilot unit data, and will operate computer-based equipment control systems and use various software tools in performing job functions. Prepare and/or implement clear operating instructions, procedures, and other key communications required in a chemical R&D setting. Lead on-the-job training of fellow technicians on an as-needed basis. To accomplish this, the position requires good verbal and written communication skills. Interface effectively with R&D researchers, other technicians, design engineers, site HSE, crafts, and supervision for the planning and execution of efficient experimental programs with the highest attention to personnel and process safety. Exhibit excellent safety leadership in the workplace, consistent with company and site HSE goals. If assigned to a shift position, may include shift leader responsibilities requiring supervision of other technicians and site facility coverage during day and off-hours operation. Min. Qualifications * Associates Degree in Chemistry or related technical field with 2 years of relevant experience working in an R&D laboratory, or significant related industry operations or laboratory experience. A Bachelor's degree in chemistry or related technical field is preferred. * Synthetic chemistry experience will be preferred. * Basic knowledge of analytical techniques such as GC, they will be expected to operate computer based equipment control systems and use various software tools in performing their job functions. * Solid background in process chemistry, manufacturing processes, laboratory or chemical process safety, lab/industrial hygiene, and personnel safety. * Solid background in chemical process equipment, computer-based process control systems, and office software tools. * Highly self-motivated individual, focused on providing quality laboratory data in an efficient manner with the ability to exhibit excellent workplace leadership in the pursuit of site HSE goals, project goals, and site/company workplace initiatives. * Problem-solving skills and be able to make competent, independent decisions in a timely fashion to ensure excellent progress on projects. * Ability to adhere to the highest performance standards of personal and process safety and exhibit good leadership in the workplace for accomplishing site/company HSE goals. * Team player with the ability to communicate clearly and concisely both orally and in writing with internal/external customers. * Standard work schedule will be 5 days per week during normal business hours, however successful applicants must be flexible and willing / able to provide overtime coverage which may require working a 12 hour rotating shift schedule to support business or project requirements. * Must be willing to work with hazardous and/or flammable chemicals (with proper safety precautions, training, and equipment). * Must be willing and able to work in environments that require frequent bending, reaching, and lifting up to 50 lbs. * Must be willing and able to work in tight or confined spaces, including wearing fresh air breathing equipment for some tasks. * Must be willing and able to work at heights above 25 feet by climbing stairs and vertical ladders. Competencies Builds effective teamsCollaboratesCultivates innovationCustomer focusDemonstrates courageDrives resultsEnsures accountabilityInstills trust and exemplifies integrity Referral Bonus: $500.00 Nearest Major Market: Houston
01/25/2021
Full time
LyondellBasell (NYSE: LYB) is one of the largest plastics, chemicals and refining companies in the world. Driven by its employees around the globe, LyondellBasell produces materials and products that are key to advancing solutions to modern challenges like enhancing food safety through lightweight and flexible packaging, protecting the purity of water supplies through stronger and more versatile pipes, improving the safety, comfort and fuel efficiency of many of the cars and trucks on the road, and ensuring the safe and effective functionality in electronics and appliances. LyondellBasell sells products into more than 100 countries and is the world's largest producer of polypropylene compounds and the largest licensor of polyolefin technologies. In 2020, LyondellBasell was named to Fortune Magazine's list of the 'World's Most Admired Companies' for the third consecutive year. Basic Function The R&D Technician will be responsible for laboratory and pilot scale unit based research and development (R&D) tasks, including running experiments, sampling, testing, measuring, recording and analyzing results to meet Chemicals R&D project goals. Roles & Responsibilities Setting up, modifying, trouble-shooting and running bench-scale laboratory equipment and operating pilot-scale units. Observing and recording laboratory and pilot unit data, and will operate computer-based equipment control systems and use various software tools in performing job functions. Prepare and/or implement clear operating instructions, procedures, and other key communications required in a chemical R&D setting. Lead on-the-job training of fellow technicians on an as-needed basis. To accomplish this, the position requires good verbal and written communication skills. Interface effectively with R&D researchers, other technicians, design engineers, site HSE, crafts, and supervision for the planning and execution of efficient experimental programs with the highest attention to personnel and process safety. Exhibit excellent safety leadership in the workplace, consistent with company and site HSE goals. If assigned to a shift position, may include shift leader responsibilities requiring supervision of other technicians and site facility coverage during day and off-hours operation. Min. Qualifications * Associates Degree in Chemistry or related technical field with 2 years of relevant experience working in an R&D laboratory, or significant related industry operations or laboratory experience. A Bachelor's degree in chemistry or related technical field is preferred. * Synthetic chemistry experience will be preferred. * Basic knowledge of analytical techniques such as GC, they will be expected to operate computer based equipment control systems and use various software tools in performing their job functions. * Solid background in process chemistry, manufacturing processes, laboratory or chemical process safety, lab/industrial hygiene, and personnel safety. * Solid background in chemical process equipment, computer-based process control systems, and office software tools. * Highly self-motivated individual, focused on providing quality laboratory data in an efficient manner with the ability to exhibit excellent workplace leadership in the pursuit of site HSE goals, project goals, and site/company workplace initiatives. * Problem-solving skills and be able to make competent, independent decisions in a timely fashion to ensure excellent progress on projects. * Ability to adhere to the highest performance standards of personal and process safety and exhibit good leadership in the workplace for accomplishing site/company HSE goals. * Team player with the ability to communicate clearly and concisely both orally and in writing with internal/external customers. * Standard work schedule will be 5 days per week during normal business hours, however successful applicants must be flexible and willing / able to provide overtime coverage which may require working a 12 hour rotating shift schedule to support business or project requirements. * Must be willing to work with hazardous and/or flammable chemicals (with proper safety precautions, training, and equipment). * Must be willing and able to work in environments that require frequent bending, reaching, and lifting up to 50 lbs. * Must be willing and able to work in tight or confined spaces, including wearing fresh air breathing equipment for some tasks. * Must be willing and able to work at heights above 25 feet by climbing stairs and vertical ladders. Competencies Builds effective teamsCollaboratesCultivates innovationCustomer focusDemonstrates courageDrives resultsEnsures accountabilityInstills trust and exemplifies integrity Referral Bonus: $500.00 Nearest Major Market: Houston