AveXis Inc.

AveXis Inc. Durham, NC, USA
Sep 19, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a Vice President of Quality Systems and Compliance (QS&C) responsible for leadership of the design and implementation of Integrated Quality Systems for AveXis GXP operations worldwide, and compliance to these requirements, local regulation and appropriate Novartis requirements, standards and systems. This role will lead the group responsible for the architecture of these systems, integration with Novartis Quality Systems and standards and will lead a team to author or contribute to the procedures governing these systems. The VP, QS&C will work towards timely implementation, providing expertise and participating fully in the management of health authority inspections. Close collaboration with both Avexis and Novartis colleagues is essential to the success of this role. Responsibilities Provide senior quality leadership to the Quality Systems and Compliance functions. Serve as a senior member of the Global Quality Team for AveXis. Provide strategic quality input on the design and architecture of AveXis' Quality System. Plan, implement and operate the Novartis integrated Quality Systems for AveXis. Define, build and lead effective teams for the management of Global Quality Systems and Global Compliance at AveXis. Define the level of alignment or integration that provides maximum benefit, then manage the implementation in accordance with that direction. Engage fully with Novartis functions responsible for Quality Systems management and Compliance Management to deliver upon agreed objectives and outcomes. Plan the globalization of the AveXis Quality System, based on prioritization and risk, across GMP and GCP operations worldwide. Design and implement Global GXP Quality Systems at AveXis, for optimized efficiency and effectiveness, meeting all appropriate compliance requirements worldwide, at the same time optimally supporting and enabling the strategic goals of AveXis. Work with the AveXis Data Integrity Officer, by contributing to assurance of data integrity through review of paper and electronic raw data. Ensure inspection preparation, management and response process readiness through own team and close collaboration with Quality Site Heads. Establish a strong quality management review system and the assessment of its adequacy. Participate in Periodic conformance audits of the operations of the system. Jointly with Quality Operations colleagues, create and maintain a monthly Global Quality Management Review meeting (QMR) to review metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics. Provide strategic quality input on the compliance aspects of AveXis' Quality System and Quality Assurance activities. Plan the globalization of the AveXis compliance program, based on prioritization and risk, across GMP, GDP, GVP, and GCP, GLP operations worldwide. Execute effectively on the compliance program, conducting audits according to plan, working with colleagues on observation responses and corrective actions to ensure proper and timely completion. Act as an expert resource for sites that self-identify potential risks or request solutions for potential compliance issues. Work with colleagues at both AveXis and Novartis to define the level of alignment or integration that provides maximum benefit, then manage the implementation in accordance with that direction. Design and implement Global GxP compliance procedures and standards at AveXis, for optimized efficiency and effectiveness, meeting all appropriate compliance requirements worldwide, at the same time optimally supporting and enabling the strategic goals of AveXis. Qualifications Minimum Bachelor's degree preferably in Microbiology, Chemistry or Biochemistry. A minimum of 15 years of experience in bio-pharmaceutical based GXP operations. Experience with viral gene therapies and/or orphan disease indications is a plus. Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections. Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations. Excellent oral and written communication skills with strong technical writing experience required. Experience leading internal audits, identifying findings, driving resolution and providing closure report. Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward. Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence. Approximately 30% travel required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
AveXis Inc. San Diego, CA, USA
Sep 18, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a Senior Scientist, Assay Support who will play a crucial role in experimental design, execution and data interpretation of bioassays for sample testing and in the support of bioassay development and optimization. The candidate must have in-depth knowledge of cell biology and a track record of working in cell-based assay optimization, routine assay execution and management under GxP environment. The ability to quickly learn, meet tight timeline, manage two or more direct reports, efficiently communicate, multi-task with excellent organization skills is extremely important to successfully fulfill responsibilities. Responsibilities Lead and manage studies performed using established bioassays. Design experiments using proper standards and controls to support various studies such as process development, formulation study, lab investigation and troubleshooting. Plan assay execution and assign to direct reports. Explain the study and plan and ensure quality data are generated. Hands-on execution of assays is also expected. Interact with collaborators to discuss planning and to report data; help managers with assessing sample priorities and lab capacity. Interpret data, put together slide deck and present data in meetings to represent the team and Bioassay group. Troubleshoot and determine root cause of issues in assay performance. Support assay development/optimization and other proof of concept studies. Establish technology platforms (e.g. western blot, qPCR) and serve as SME for these platforms. Develop assays and build testing capacity as needed. Design/execute experiments as needed using various techniques to support proof of concept studies and ad-hoc experiments. Manage cell banking activities and other critical reagents programs. Help direct reports develop technically solid automation protocols. Lead/Contribute to GxP workflow within the Bioassay group. Lead or contribute to drafting of SOPs and other technical documents such as study protocols and reports. Establish control trending and monitor performance of various assays. Manage 2 or more direct reports by providing technical and scientific oversight and mentoring to help grow their career. Manage lab operation by overseeing lab instrument/inventory, ensuring lab safety and serving as the point of contact person for such matters (e.g. interaction with facility). Qualifications Bachelor's degree and must have minimum of 15 years of industry experience (10 years for Master's degree). Must have very strong cell culture techniques with good understanding of cell behavior and cell biology to be able to independently determine health and performance of cells that are used in critical assays. Extensive experience in optimizing, executing and managing bioassay performed in 96well plate setting such as imaging-based assays, ELISA and luminescence/fluorescent-based assay. Proven ability to design experiments using appropriate standards, controls and assay layout and to troubleshoot as needed. Broad experiences in cellular, biochemical and molecular biological methods including but not limited to immunostaining, flow cytometry, protein gel, Western blot, PCR and qPCR. Working knowledge in DOE and JMP software is a significant plus. Basic understanding of regulatory agency guidance such as FDA, ICH and EMA and hand-on experience is a plus. Enjoy learning and challenges. Especially, must be able to learn new instruments and master their software quickly. Ability to work in a fast-paced small but growing team environment and to prioritize work from multiple projects. Must be highly reliable and goals/deadlines oriented. Must have exceptional written and verbal communication skills to operate in an environment with many moving parts and diverse collaborators. Must possess excellent organization skills to be able to manage several projects in parallel. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1
AveXis Inc. Durham, NC, USA
Sep 18, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Senior Scientist is responsible for contributing to the development and improvement of the upstream manufacturing platform processes used to manufacture, as well as the data and reports to support approval of, AveXis gene therapy products. This individual will lead and support activity with internal and external organizations to plan, execute, and document experiments and early manufacturing that define the process, and method of delivery to the clinical and commercial sites. The Scientist will provide leadership and support for process, analytical, and characterization knowledge related to the production of Avexis gene therapy products, and the raw materials needed to make them. Responsibilities of primary importance are to ensure the execution of time-sensitive experiments, studies, and validation at external partners while capturing related data and knowledge, to advance the development of Avexis products from Research to Development, and on to GMP manufacturing. Complete requisite training on all applicable policies and procedures related to the job function. The successful candidate will take responsibility to ensure all documentation and reports are accurate, complete, and suitable for using in support of production, characterization, and regulatory approval of Avexis products. Responsibilities Provide scientific and technical input for process-related issues at internal Avexis sites, as well as with external partners. Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift. Identifying and implementing potential process improvements in conjunction with manufacturing operations. Participating in start-up efforts of new equipment, software or processes in manufacturing. Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes. Reviewing/providing feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc. Establishing small-scale production processes and using scaled-down lab processes to enable process troubleshooting. Participate in leading investigations in partnerships with Manufacturing, Quality, and other business units at the site, to determine root cause for variation, implement solutions, and ensure corrections are effective. Participate in the collection and interpretation of data, and collaboration with other departments on all manufacturing related issues to drive issue resolution and support AveXis goals. Qualifications Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field, Master's degree or PhD preferred. Excellent oral and written communication skills. 6-10 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture. Proven expertise with a variety of cell culture and bioreactor technologies. Ability to effectively and efficiently analyze and interpret data to further progress development strategies. Working knowledge in DOE is a significant plus. Approximately 10% to 25% travel may be required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-JH1
AveXis Inc. San Diego, CA, USA
Sep 18, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a Senior Scientist, Molecular Biology who will be responsible for executing in vitro experiments for AveXis programs. This individual will work in the laboratory, responsible for execution of experiments related to existing and pipeline products. This individual will work with scientists in the Research Department. Responsibilities Lead and direct the activities within the molecular biology functional group supporting all research activities for pipeline development. Supervise the molecular biology group overseeing each ongoing project and facilitate teamwork. Collaborate with project leaders to plan, coordinate, and monitor the timely execution and completion of various research projects. Oversee the maintenance of accurate, comprehensible, and current laboratory notebooks. Presentation of data to the internal senior management team and external scientific presentation at conferences and meetings. Cell culture experiments supporting existing and pipeline programs. Cloning, protein expression, purification. Mammalian expression systems to support protein expression studies. Transient transfection in cell culture systems. Design of experiments to identify and optimize key parameters for protein expression. Timely provision of data and documentation in reports to support intellectual property filings and regulatory submissions. Support regulatory submissions and interactions with the FDA around new products. Qualifications Advanced degree (PhD preferred) in Biology, cell biology, pharmaceutical sciences, or related field plus minimum 5+ years hands-on experience. Laboratory experience in a molecular and cell biology laboratory Publications and/or demonstrable experience desired Specific laboratory experience desired includes, but is not limited to: Culture of mammalian cells in cell culture Molecular biology including cloning and ddPCR Protein expression Production of recombinant virus Up to 25% travel may be required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1
AveXis Inc. San Diego, CA, USA
Sep 18, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a highly motivated and capable Senior Scientist to join our Research and Development team. The position focuses on design, development, optimization, troubleshooting, and execution of cell-based assays supporting AveXis programs. The incumbent will work with Scientists across the Research and Development team. Responsibilities Demonstrates innovative design, development, and execution of pipeline projects through literature review and scientific teamwork. Leverages strong understanding of cell-based assays, from early development through qualification and validation. Cell line development, cell culture, and cell banking Develop cell-based reporter and potency assays Support assay development/optimization and other proof of concept studies Establish technology platforms (e.g. western blot, ddPCR, enzymatic assays) and serve as SME for these platforms. Develop assays and build testing capacity as needed. Molecular cloning, protein expression and detection Mammalian expression systems to support protein expression studies Cell line generation by transient/stable transfection or viral transduction May manage associates in either assay development or assay execution. Reviews data and supports troubleshooting. Leads both from the bench (hands-on laboratory work) and from the desk (designing studies, analyzing data, preparing reports and documents). Readily adapt to changing project needs; independently plan and execute experiments. Leads and supports research initiatives such as new technology development and continuous improvement projects. Adheres to good laboratory conduct, documentation practices, and safety guidelines. Qualifications PhD degree in biology, cell biology, pharmaceutical sciences, or related field with 2+ years biopharmaceutical experience. Extensive working knowledge of cell-based assays for potency. Strong background in assay qualification/validation, with knowledge of viral gene therapy (adeno associated viral vectors) preferred. Experience with basic molecular biology and biochemistry methods: PCR, qPCR, ddPCR, DNA cloning, Southern blot and Western blot. Experience with protein expression, quantification and detection by immunostaining and high content imaging. Experience with quantitative and qualitative methods, including ElISA, MSD, colorimetric assays, enzymatic assays and reporter assays. Advanced cell culture expertise (immortalized, primary cells, stem cells or iPS cells), including passaging, transfection, clonal selection, mass production, and cryobanking. Ability to work in a fast-paced small but growing team environment and to prioritize work from multiple projects. Must be highly reliable and goals/deadlines oriented. Up to 10% travel may be required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1
AveXis Inc. Libertyville, IL, USA
Sep 18, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a Senior Director of Global Engineering & Facilities to manage the Capital budget portfolio and lead the team implementing Capital projects. The incumbent will be a member of Global Engineering & Facilities (GEF) leadership and have accountability for the success of the GEF organization. The company is currently in substantial growth mode with open and planned projects at all four US locations across 15+ facilities to deliver needed infrastructure for personnel, labs and manufacturing. Responsibilities Work closely with Finance and internal customers to thoughtfully develop the annual Capital investment portfolio and provide ongoing oversight and management of the portfolio. Establish procedures and practices for Capital portfolio management including reporting, metrics/performance indicators and project/portfolio risk assessment to monitor and trend results, and take actions to correct, prevent and/or improve execution and future performance. Oversee the development and maintenance of procedures and practices for Capital investment planning, design, construction, and all necessary project controls. Lead the team in planning, delivery and execution to effectively execute on projects. Provide oversight to ensure completion of all phases of a project in a timely and efficient manner, meeting or exceeding budget expectations. Oversee all plans, designs and estimates of time and cost; oversee construction and maintenance of structures, facilities, systems and components. Support the development and application of engineering standards and procedures; provide guidance on issues within the engineering function. Qualifications BS degree in a technical discipline (Engineering preferred) with a minimum of 15-20 years of relevant experience; Master of Business Administration (MBA). 10+ years' experience in capital projects delivery or management, ideally in a bio - pharmaceutical manufacturing environment or related space. Experience implementing or managing an effective technical discipline at a bio-pharmaceutical company. Deep technical knowledgeable in design, construction, qualification and operation of office, laboratory, manufacturing (bioprocessing of Drug Substance and Drug Product), plant utilities and clean utilities. Excellent verbal and written communication skills. Dynamic interpersonal skills, including the demonstrated ability to manage through influence. Strong business skills including budget management experience. Demonstrated planning and organizational skills including project management. Proven knowledge of best practices as they relate to facility/process/manufacturing engineering. Demonstrated expertise in mentoring/team development, change management, planning/organizing. Ability to work on multiple projects and manage various priorities and timelines and to adapt quickly to changing circumstances. High degree of customer focus (internal/external) and demonstrated collaboration in a team environment. Results oriented with the ability to demonstrate resiliency, ownership and drive. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-JH1
AveXis Inc. Illinois, USA
Sep 16, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a Clinical Documentation Specialist that will manage assigned study Trial Master Files (TMFs) and oversee TMF health by conducting quality control (QC) reviews, maintaining assigned study trackers and ensuring documents maintained in the TMF are appropriate and adherence to Standard Operating Procedures, Good Clinical Practice, Good Documentation Practices, International Council for Harmonization E6(R2), and ALCOA+ standards. Responsibilities Upload documents into the TMF and Veeva systems. Manage assigned TMFs and oversee TMF health to ensure TMF inspection readiness in real time. Task prioritization and timeline adherence to support inspection readiness. Ensure timely resolution of documents with quality issues and appropriate issue escalation. Collaborates cross functionally to develop TMF related plans (e.g., Transfer and Migration Plan, TMF Plan, Expected Document List [EDL] Plan) for assigned studies. Ad-hoc back-up for support site monitoring: Advise monitors on current GCP/GDP/ALCOA+ standards. Participate in Investigator Site Folder (ISF) reconciliation. Support the development of site handout of ISF GCP guidance. Collaborate with monitoring team to develop and/or update monitoring specific TMF trainings. Generate, analyze, and circulate TMF reports and KPIs (e.g., QC Rejected Documents, TMF Health, EDL Completeness) to all study stakeholders. Use results to identify and mitigate TMF documentation risks. Conduct Quality Checks (QC) and review content of documents to ensure accuracy and completeness (metrics meet Support migration of external TMFs by transcribing data or QCing already transcribed data. Effectively manage use of electronic systems and tools (e.g. Veeva Vault, SharePoint, ACE, ComplianceWire, etc.). Collaborate with internal AveXis stakeholders to manage study specific Expected Document List (EDL) 'Requiredness' and 'Expected Numbers'. Maintain assigned study specific document tracker(s) in a timely manner by entering study specific data and reviewing for missing documents, as applicable. Assist with internal and external study team TMF user access for assigned studies. Act as primary TMF SME for assigned studies. Support Veeva Vault eTMF system management and maintenance as back-up Clinical Administrator. Update TMF training materials as needed. Document and track TMF trainings. Identify trends and process improvements. Learn current FDA, MHRA, EMA, PMDA and other local regulations relevant to clinical study document creation, processing, management and archival. Act as assigned study TMF representative at study team meetings, participate in collaborative efforts and play an important cross-functional role in TMF document retrieval, guidance, and management for assigned studies. Qualifications Bachelor's degree required. 1+ years of experience working in a clinical research/biotech/pharma company/CRO, preferred records/document/TMF management department or 2+ years in academic research or healthcare setting. Exposure to TMF, preferably Veeva Vault. Familiarity with MS Word, MS SharePoint, Adobe Acrobat Professional, MS Excel, MS Visio, and MS PowerPoint. Familiarity with interpretation of applicable FDA, Canadian, EU and ICH guidelines related to clinical trial and TMF management, preferred. Familiarity with drug development and clinical trial operations, including other functional areas involved, preferred. Ability to multitask, prioritize, and work under pressure in adhering to deadlines. Verbal and written communication and presentation skills. Project management and organizational skills. Ability to apply knowledge to new situations. Strong work ethic, excellent organizational skills, strong oral and written communication skills, have a 'can do' approach, strong problem-solving skills, and be a team player. Ability to maintain a high level of quality, accuracy, and attention to detail in a fast-paced environment with shifting priorities. Proactive, self-motivated, excel at relationship building, and able to work independently with minimal supervision. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1
AveXis Inc. Libertyville, IL, USA
Sep 16, 2019
Full time
Overview Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a Maintenance and Reliability Technician to perform all maintenance functions on production and facilities equipment for our Manufacturing facility. Responsibilities include routine inspection and repair or replacement of defective or faulty parts on machines and related equipment. All work to be performed ensuring good workmanship with minimum delay. Responsibilities Support the safe and effective operation of the plant and the facility. Perform preventive and predictive maintenance on production equipment and utility systems. Scope, plan, and execute repairs to and installation of plant machinery. Coordinate with site departments daily appropriate course of action to maximize uptime and quality performance of respective area. Operate machinery for purposes of training, troubleshooting, or as needed to support production activities. Initiate and participate in documented troubleshooting studies on equipment to outline opportunities for improvements. Document clear problem description, symptom, root cause and solution. Proven reasoning, troubleshooting and analytical thinking skills. Use shop equipment to repair or modify parts and equipment. Knowledge of, perform preventive maintenance, troubleshoot, and repair: AC and DC Motors & Drives Breakers and Fuses Pressure and Flow Controls Pressure Transducers/Switches Hydraulic and Pneumatic Systems Cylinders Filtration Systems Dampers Valves Pumps Drive Systems Piping Systems Pumps Fans Compressors Fire Protection Systems Qualifications Proficient in using personal computers and a working knowledge of software such as MS Excel and Word. Ability to analyze, investigate and help solve equipment technical issues. Good communication skills, both verbal and written. Must be flexible to work nights, weekends, and holidays as required. Ability to work with very minimum supervision. Must be proactive. Must have a good attitude regarding safety and lock out procedures. Technical school education in the areas of Manufacturing Engineer, Mechanical Engineering Technology, Electrical Engineering Technology or 6+ years equivalent education/experience. Proven experience in machine maintenance and troubleshooting skills. Good understanding of GMPs with experience in pharmaceutical environment. Read and understand mechanical and assembly drawings, hydraulic/pneumatic, and electrical schematics. Read and understand P&ID (Piping & Instrumentation Diagram). Occasionally lift and/or move up to 50 pounds. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RM1
AveXis Inc. Libertyville, IL, USA
Sep 15, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. Responsible for defining and leading development and improvement activities for the manufacturing processes used to manufacture AveXis gene therapy products. This individual will also be responsible for the interpretation of continued process verification data and collaboration with other departments on manufacturing related issues to drive resolution and process improvements. Responsibilities Serving as a scientific and technical lead for process-related issues and investigations at the site. Lead and mentor staff. May formally manage a team including writing performance reviews and annual goals, holding one-on-ones, and handling HR related matters. Partnering with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards. Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift. Defining potential process improvements in conjunction with the global process owners and operations and leading the implementation of process changes. Participating in start-up efforts of new equipment, software or processes in manufacturing. Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes. Providing technical/scientific support on project deliverables such as remediation initiatives, plan reports, etc. Utilizing small-scale production processes and scaled-down lab processes to enable process troubleshooting, with the potential to oversee these experiments at external partners. Provide leadership for tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing. Identify opportunities to implement operational excellence and continuous improvement. Partner with Quality to ensure a compliant manufacturing environment. Assist the technical operations team to resolve any issues related to production. Completion of requisite training and applicable policies and procedures related to the job function. Qualifications PhD in biochemistry, chemical engineering, bioengineering, or a related technical field and at least 8 years of experience in support of biopharmaceutical manufacturing OR M.S. degree in biochemistry, chemical engineering, bioengineering, or a related technical field and at least 10 years of experience in support of biopharmaceutical manufacturing OR B.S. degree in biochemistry, chemical engineering, bioengineering, or a related technical field and at least 12 years of experience in support of biopharmaceutical manufacturing. Excellent oral and written communication skills. 12+ years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish preferred. Familiar with global regulations on cGMP manufacturing of drug substance, drug product devices, validation/qualification requirements preferred. Strong technical writing ability. Proven ability to effectively lead and participate on teams preferred. Leadership experience of technical staff either directly or in a matrix organization preferred. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-JH1
AveXis Inc. San Diego, CA, USA
Sep 14, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a talented, motivated and detail-oriented Scientist to join the dynamic and growing analytical team to establish innovative analytical methods suitable for lot disposition and characterization of gene therapy drug products and substances. Responsibilities With minimum supervision and guidance, design, develop, optimize and qualify/validate HPLC, CE, FFF-MALS based analytical methods suitable for gene therapy characterization, lot release and stability studies based on strong scientific understanding of the products. Serve as subject matter expert working with CROs by providing technical input and feedback. Support tech transfer of analytical methods to internal QC groups and/or CROs. Effectively communicate results both internally and externally via presentations or written reports. With general guidance, author/review SOPs and technical protocols/reports. Generate/summarize scientific data in support of regulatory filings including IND and BLA. Mentor junior group members on daily laboratory work and general analytical lab skills. Participate and give suggestions on lab designing/management and instrumentation purchasing. Qualifications Ph.D. or M.S. in analytical chemistry or related scientific discipline is required. 2-5 years (Ph.D) or 5-8 years (M.S) of biopharma industry experience is required. Proven working knowledge and hands-on experience with analytical method development/qualification/validation (SEC, FFF, IEC, RP-HPLC, CE-SDS, iCIEF, MALS, DLS and others) for proteins, vaccines and gene therapy drug characterization and lot release. Previous working experience with process related residual assays is a plus. Good hands on experience and troubleshooting capability in analytical instrumentation (including but not limited to FFF, CE, HPLC, MALS, DLS, MS) and analytical assays based on the thorough understanding of assay principles. Good understanding and working experience with analytical software (including but not limited to Chromeleon, Empower, Chemstation, Astra, 32 Karat). Previous administrator role in analytical software is a plus. Previous GxP experience is preferred. Self-motivated, hard-working and detail oriented. Demonstrated capability to work in a fast-paced team environment with goal-oriented approaches and to prioritize work from multiple projects with a can-do attitude is required. Excellent written and verbal communication skills. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1
AveXis Inc. San Diego, CA, USA
Sep 14, 2019
Full time
Overview Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking an experienced and exceptional Senior Scientist to join the dynamic and growing analytical team to establish innovative analytical methods suitable for lot disposition and physicochemical characterization of gene therapy drug products and substances. Responsibilities Act as key expert within the analytical chemistry group in developing, optimizing and qualifying/validating HPLC, CE, FFF based analytical methods suitable for gene therapy characterization, lot release and stability study based on thorough understanding of the scientific background of the products. Proactively identify assay issues, new assay needs and provide scientific suggestions and solutions. Serve as SME to work with CROs for method development/qualification/validation, actively participate in scientific discussions and provide input/feedback. Work closely with functional groups (for example, R&D, QC/QA, process development and manufacturing groups) to ensure win-win collaboration in developing/transferring analytical methods suitable for characterization, stability, and release testing purpose. Effectively communicate results both internally and externally by presentations or written reports. Independently author/review SOPs and technical protocols/reports; contribute to data generation/interpretation/summarization in support of regulatory filings including IND and BLA, as well as post submission review responses. Supervise/mentor junior group members on daily laboratory work, experimental design, data interpretation and troubleshooting. Train new group members on basic analytical lab skills. Actively participate and give suggestions on lab designing, instrumentation purchasing and strategic planning. Qualifications Ph.D. or M.S. in analytical chemistry or related scientific discipline is required. 5-8 years (Ph.D) or 8-10 years (M.S) of biopharma industry experience is required. Extensive knowledge and experience with a broad spectrum of analytical techniques (including but not limited to SEC, FFF, IEC, RP-HPLC, HIC, HILIC, CE-SDS, CZE, iCIEF, LC-MS) for lot disposition and characterization of biologics drug product candidates. Good understanding of biophysical characterization methodology using MALS, DLS, AUC, DSC, TEM type of techniques is highly desired. In-depth understanding and troubleshooting capability of analytical instrumentation and software (including but not limited to HPLC, CE, FFF, MALS, DLS, Chromeleon, Empower, Chemstation, Astra, 32 Karat). Extensive working experience on antibodies, vaccines, gene therapy drugs or nanoparticle drug deliveries is required. Strong technical writing skills and experience in authoring development reports and SOPs with detail-oriented trait. 1-3 years of GxP experience in qualifying and/or validating analytical assays is preferred. Highly motivated, hard-working and detail oriented. Strong ability to work in a fast-paced team environment with highly goal-oriented approaches and to prioritize work from multiple projects with can-do attitude is required. Ability to proactively bring in and assess value-added platforms based on special needs associated with characterization of the gene therapy drug products is essential. Excellent written and verbal communication skills. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1
AveXis Inc. Durham, NC, USA
Sep 13, 2019
Full time
Overview Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, Inc., a Novartis Company, is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a highly motivated and solution-driven individual to join the dynamic and growing Quality Control (QC) team at the Durham, NC site. The individual will collaborate closely with Analytical Development, Quality Control, and Project Management teams to qualify, validate, transfer and improve analytical methods. She or he will play an active role in establishing the site QC lab operations to support development and commercialization of new gene therapy medicines. The Sr QC Specialist is responsible for routine sample testing under GMP or non-GMP modes, laboratory maintenance, and participating in method qualification, validation, transfer, and improvement. The candidate should possess strong understanding of QC testing operations and provide expertise in several QC assays, such as, ELISAs, HPLC, AUC, SDS-PAGE, Western Blot, pH, appearance, osmolality, conductivity, sub-visible particulates, etc.. She or he is expected to work independently on problem solving, lab investigations, and implementation of preventative and corrective actions. He/she will be able to work effectively within the group, within Quality, and across sites. Additional responsibilities include adherence to all GMP requirements, an understanding of FDA/EMEA regulations, effective interactions/communication with Quality management. Experience in cell culture and cell-based assays (e.g. virus infection assays and proliferation assays) is desired. Responsibilities Serve as SME in several QC assays, ELISAs, HPLC, AUC, SDS-PAGE, Western Blot, pH, appearance, osmolality, conductivity, sub-visible particulates, etc. Perform QC assays for in-process, release, or stability samples. Review and trend QC testing results. Lead or participate in assay troubleshooting Perform testing for qualification, validation, and transfer. Manage the procurement, implementation, use, and maintenance of equipment, instrumentation, and computer systems. Write and revise documents such as SOPs, and study protocols and reports. Lead investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner. Identify and implement new technologies to improve the compliance and efficiency of QC operations. Represent QC to work with other departments including Global Quality Control, Analytical Development, Quality Assurance, and Manufacturing to address compliance issues and to implement corrective actions and to improve programs. Perform other related duties as assigned Qualifications Minimum B.A. or B.S. in biochemistry or related scientific field. Minimum of 8 years of experience preferred with biological products in a GMP Quality Control laboratory. Excellent oral and written communication skills with strong technical writing experience required. Potential for up to 20% travel require This position will be based out of our Manufacturing site located in RTP, NC. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-TT1
AveXis Inc. Libertyville, IL, USA
Sep 13, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Warehouse Associate is responsible for receiving, sampling, storing, issuing and shipping materials. This individual will work with the supply chain team to ensure inventory levels are accurate and materials are stored in the appropriate locations. This individual will support all manufacturing activities at the site. Responsibilities • Receive all materials that come into the facility • Locate and store all inventory items in the ERP system and physically locate them. • Work with Production and Labs for materials that are required and need to be issued out • Responsible for shipping all materials out of the facility. This includes hazmat shipments, export shipments and temperature sensitive shipments. • Responsible to stay current on all training and shipping regulations. • Complete inventory cycle counts to maintain current inventory accuracy. • Organize the warehouse and outside of the POD manufacturing area. Examples include KANBAN processes and waste streams. Qualifications • H.S. Diploma required, B.S. degree is preferred. • This is an entry level position, but 1+ years of pharmaceutical warehouse material handling experience is preferred. • Must be certified to operate a forklift (propane sit down). • Strong communication and organizational skills, detail oriented. • Must be physically able to lift and move materials (up to 50 lbs.) safely. • Must work well in a team setting. Must maintain a professional work environment. Very Important - must have a valid driver's license with no driving violations within the last 3 years. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RM1
AveXis Inc. Libertyville, IL, USA
Sep 13, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a Facilities Specialist Site Services to assure the effective function of a cGMP facility and to provide an efficient and safe working environment for employees and their activities by using best business practices to manage resources, services, and processes to meet the needs of the company. Responsibilities Develop and implement a facility management program including preventative maintenance and life-cycle requirements. Management and development of pest control program. Conduct and document regular facilities inspections. Ensure compliance with health and safety standards and industry codes. Allocate and manage facility space for maximum efficiency. Coordinate intra-office moves. Supervise maintenance and repair of architectural aspects of the facilities. Oversee facility refurbishment and renovations. Plan and manage facility central services such as pest control, reception, security, cleaning, and architectural repairs. Implement best practice processes to increase efficiency. Obtain quotes from vendors and suppliers. Calculate and compare costs for goods and services to maximize cost-effectiveness. Negotiate contracts to optimize delivery and cost saving. Coordinate and monitor activities of contract suppliers. Manage contractor and vendor relationships. Manage and review service contracts to ensure facility management needs are being met. Ensure delivery schedules, quantity and quality criteria are met. Check completed work by contractors and vendors. Verify payment and invoicing match contract pricing. Manage, develop and training of contract staff. Prepare and track facility budget. Monitor expenses and payments. Generate and present regular reports and reviews of facility-related budgets, finances, contracts, expenditures and purchases. Develop and implement cost reduction initiatives. Provide prompt response to requests and issues from facility occupants. Qualifications Bachelor's degree in Facilities Management or 10 years of experience, Facilities Engineering or related qualification such as project management, business management, or construction management. Proven ability to work in a cross functional team environment, with excellent communication and organizational skills. Working knowledge of principles and practices of project management, business administration, procurement, contracts, financial principles and practices. Sound knowledge of health, safety and environmental regulations. Experience in construction, maintenance, and all facets of facility operations. Strong cGMP and regulatory knowledge. Strong knowledge of architectural finishes and components. Planning, problem analysis, and decision-making skills. Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS). Proficient computer skills utilizing MS Office suite applications, Building Management Systems, Computerized Maintenance Management Systems (CMMS). Working in a team environment with excellent communication and organizational skills. Customer service focused. Ability to climb ladders and lift up to 50 pounds. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-AR1
AveXis Inc. Libertyville, IL, USA
Sep 12, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Process Engineer is responsible for providing engineering, validation and maintenance support to the process manufacturing equipment, facility and utilities at the manufacturing site. Equipment may include major processing equipment such as bioreactors, tangential flow filtration, chromatography, filling equipment, support systems such as incubators, freezers biosafety cabinets, offline benchtop instruments or facility/utility systems. This individual will be required to develop an understanding of current and future processes and translate these into the facility and equipment requirements at the manufacturing site. Responsibilities Ensuring new equipment is appropriately designed/qualified and existing processes runs in a compliant manner through equipment lifecycle. To include: Investigating any equipment or process deviations. Developing corrective actions to prevent reoccurrences. Appropriate change management for any changes to qualified systems. Owns and manages changes to the process equipment to maintain equipment in a validated state. Problem solve any technically related issues impacting production. Develop and implement equipment reliability and maintenance strategies that are compliant, effective and cost appropriate. Routinely monitor equipment performance. Develops project objectives working with user requirement and business plans. Determines project specifications and appropriate technology's to be implemented. Establish equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS). Support investigation non-conformances associates with equipment, facility or utility systems. Participate in all FDA and internal audits of the manufacturing facilities and process equipment and respond to any observations received. Responsible for maintaining quality standards to meet GMP requirements, CFR's and internal company policies with respect to equipment systems. Represent process engineering and validation in any technology transfer activities. Responsible for either leading or providing SME support on capital related projects. Qualifications Minimum B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, or 4 years of equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations. Experience in the development, automation, and manufacture of gene therapy products, medical devices, instruments, or biotechnology. In-depth knowledge of FDA regulations and GMP systems and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility. Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products. Excellent oral and written communication skills. Strong technical writing ability required. Travel as required to other internal sites, vendors, and CMOs as required (~20%). The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-RM1
AveXis Inc. Durham, NC, USA
Sep 12, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a Senior Manager, Financial Planning and Analysis to support multiple functional areas - in particular, Regulatory, Research, and Clinical/Medical functions - from a financial planning and analysis perspective. The Senior Manager will drive financial planning and forecasting for the assigned functional areas, serve as a key financial interface between Finance and business leaders, work often cross-functionally to drive major business initiatives and play a leadership role in setting the long term financial directions of the company. Responsibilities Provides regular updates on how team is tracking against expense and resource requirements vs. approved budget and Latest Forecast/Best Estimate (LBE) plans. Monitor performance indicators, highlighting trends and analyzing causes of unexpected variances. Leads the expense planning, annual budgeting and real-time LBE forecasting process for numerous departments. Provide business support and analysis (overall financial planning and analysis to all departments). Monitor performance indicators, highlighting trends and analyzing causes of unexpected variances. Lead management financial reporting package. Analyze complex financial information and reports to provide accurate and timely financial recommendations to management for decision making purposes. Qualifications BS/BA Degree. MBA and/or CPA desirable. 8+ years of biotech/pharmaceutical industry experience preferably supporting and partnering with R&D and Overhead departments from a finance perspective. Excellent written and oral communication skills. Excellent planning and organization skills. Strong interpersonal skills commensurate with the need to work closely with all departments and at all levels of the organization. Ability to maintain the highest degree of confidentiality and integrity, represent the company's high ethics, moral behavior, and professionalism The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #L1-TT1
AveXis Inc. Libertyville, IL, USA
Sep 12, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a Vice President, Regulatory CMC to lead all regulatory CMC business, oversee regulatory CMC activities, and maintains the regulatory CMC applications. Responsible for formulating the regulatory CMC strategy of submissions to the US FDA, EMA, and other regulatory authorities as well as managing interactions with regulatory authorities on CMC issues. Responsibilities Create overall regulatory CMC strategy for new product candidates to attain rapid regulatory approvals. Develop, lead and drive CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance. Ensure strategies are successfully executed, proactively modifying strategy and actions to adjust to environment changes. Lead and drive all CMC content for submission activities (planning, authoring, reviewing, coordination, submission) for original INDs, IND amendments, investigational medicinal product dossiers (IMPD) for inclusion in Clinical Trial Applications, BLAs and MAAs. Serve as RA CMC liaison with the FDA and develop global Regulatory contacts. Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including Investigator Brochures, Annual Reports and Background Documents for Regulatory Authority meetings. Work with regulatory organizations and partners Europe and Asia to prepare applications, respond to queries to enable maintenance of CMC needs for clinical activities outside of the United States. Establish, manage, and maintain a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to colleagues. Ensure communication and alignment on CMC regulatory strategy through partnership and communication with internal key stakeholders, including representing the regulatory department at strategy and specification committee meetings. Assure compliance with regulatory standards and guidance documents. Ensure that CMC-related changes are reported to authorities in accordance with regulatory requirements. Conduct risk assessments of global CMC regulatory issues. Builds world class Regulatory CMC functions to meet the Company's growing business needs. Maintains and continues to build the Company's excellent reputation with the regulatory authorities. Directly supervises employees. Indirectly supervises employees through a dotted line structure or via other subordinate managers. Qualifications MS/MA degree in related discipline and 15 years of related experience with at least 5 years at a director or above role; PhD, MD, or PharmD is preferred. A proven track record of successes in neurological drug submissions (e.g., NDA, IND, MAA), is preferred. Experience with biologics and cell therapy drug development. Experience with gene therapy drug development preferred. Knowledge of the drug development process, drug laws, and global regulations and requirements. Strong analytical skills, problem solving ability and presentation skills required. Flexibility and ability to prioritize and manage multiple tasks simultaneously. Preference to manage projects. Effective oral and written communication Possess ability to apply and integrate the regulatory and compliance experience into business strategy. Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing. Interprets, executes and recommends modifications to companywide policies and/or divisional programs. Develops departmental policies and oversees and/or authorizes their implementation. Establishes organizational policies in a major segment of the company. Has extensive knowledge of other related disciplines. Applies strong analytical and business communication skills. Proficient with broad use computer applications such as MS Office and specialized applications as needed for job. Travel up to 15% required, US and EU. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-EC1
AveXis Inc. Durham, NC, USA
Sep 12, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. AveXis is seeking a Manufacturing Specialist to provide support to Clinical and External Manufacturing Partners. Must be highly motivated, organized, solution-oriented, and efficient with strong technical aptitude and the ability to work effectively with multiple team members. This will be a fast-paced role within a cross functional project team. Responsibilities Supports strategic goals to deliver multiple rare disease blockbusters by overseeing on-the-floor operations at CMO partners. Becomes an expert at the CMO regarding the manufacturing process, documents, and systems, with the ability to provide troubleshooting assistance on and off the floor when issues arise. Works closely with external manufacturing partners (i.e., Plasmid suppliers, drug substance manufacturers) and internal manufacturing sites to develop project plans, risk mitigation strategies and timelines/milestones for external production. Tracks progress, including coordinating the reporting of the KPIs. Manages process by ensuring smooth operation of external collaborations, such as project team meetings, data exchange, and other kinds of interactions. Supports efforts to increase alignment and mutual understanding between collaboration participant. Interfaces with internal functional group leaders including Engineering, Manufacturing, Quality Control, Quality Assurance, and Supply Chain to ensure aligned strategies and timelines. Assists with inventory management and shipment of materials between sites. Supports technology transfer activities. Drives change controls and document revisions at CMO. Reports on project progress identifying issues and risks and offering viable solutions and opportunities as they arise. Qualifications Bachelor's degree required. 5 years of relevant experience. Cell culture experience required. GMP manufacturing-related experience required. Proven ability to manage multiple high-level parallel tasks effectively using technology (i.e. MS Project, Power Point), work unsupervised and possess the ability to apply new techniques using strong prioritization skills. Must display effective planning, organizational, and critical thinking skills, innovativeness, and keen attention to detail and excellent follow through. The incumbent must have strong interpersonal skills. Up to 75% US based travel The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
AveXis Inc. Durham, NC, USA
Sep 11, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. The Supervisor, Quality Control (QC) Sample Management serves as the owner for all work processes associated with the Product Sample Management programs. He/she oversees the site sample management activities and team and ensures test scheduling is executed in-house or at 3rd party contract laboratories according the respective sampling plans and stability studies. The Supervisor serves as the subject matter expert for sample control during regulatory inspections and as the document owner for procedures in support of the Product Sample Management programs. A potential candidate will possess a strong understanding of sample management processes, aseptic sampling practices, and QC documentation workstreams. Responsibilities Serves as owner for work processes associated with AveXis Sample Management programs. · Ensures scheduling and testing of stability lots. · Manages all sample management activities from collection through execution data entry and review. · Conducts data analysis and authors trending reports. · SME for sample control processes during regulatory inspections. · Document owner for procedures and work instructions in support of Sample Management. · Monitors regulations for changes that impact process, updates process as required. · Identifies and generates process related metrics and monitors for efficiency. · Generates metrics for sample management programs. · Provides release data summaries for batch release. · Provides stability data summaries to Global Stability Program. · Authors Change Controls and assesses sample handling impact for proposed changes. · Provides Quality representation on Product Working Teams for: - Impact Assessments - Deviations - CAPA · Interviews and trains employees. Acts as subject matter expert for the team. · Adheres to and ensures compliance with GMPs, identifying and implementing corrective and preventive actions. Qualifications Bachelor's Degree in Chemistry, Biology or related sciences. · Minimum 6 years of relevant experience in pharmaceutical testing laboratory. · Prior experience with QC Sample Management and LIMS. · An understanding of FDA/EMEA regulations. · Knowledge of Excel or comparable software solutions for management and analysis of data. · Ability to work independently and effectively. · Ability to prioritize and deliver on tight timelines. · Strong communication skills with ability to interact effectively with site leadership. · Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes teamwork, collaboration, influencing, motivating, and consensus and team building. · Good critical thinking, deductive reasoning, and decision-making skills. · Up to 10% travel required. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #L1-TT1
AveXis Inc. Longmont, CO, USA
Sep 11, 2019
Full time
Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission. AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 ( SOD1 ) gene. AveXis is seeking a HVACR Maintenance and Reliability Technician II to perform all maintenance functions on production and facilities equipment for our Manufacturing facility. Responsibilities include routine inspection and repair or replacement of defective or faulty parts on machines and related equipment. All work to be performed ensuring good workmanship with minimum delay. Responsibilities Qualified candidates must be available to work off shift as needed supporting 24X7X365 manufacturing facility. Support the safe and effective operation of the plant and the facility. Perform preventive and predictive maintenance on production equipment and utility systems. Scope, plan, and execute repairs to and installation of plant machinery. Coordinate with site departments daily appropriate course of action to maximize uptime and quality performance of respective area. Operate machinery for purposes of training, troubleshooting, or as needed to support production activities. Initiate and participate in documented troubleshooting studies on equipment to outline opportunities for improvements. Document clear problem description, symptom, root cause and solution. Proven reasoning, troubleshooting and analytical thinking skills. Use shop equipment to repair or modify parts and equipment. Knowledge of, perform preventive maintenance, troubleshoot, and repair: AC and DC Motors and Drives Breakers and Fuses Pressure and Flow Controls Pressure Transducers/Switches Hydraulic and Pneumatic Systems Cylinders Filtration Systems Dampers Valves Pumps Drive Systems Piping Systems Pumps Fans Compressors Fire Protection Systems Qualifications Minimum 3-5 years relevant experience. Proficient in using personal computers and a working knowledge of software such as MS Excel and Word. Ability to analyze, investigate and help solve equipment technical issues. Good communication skills, both verbal and written. Must be flexible to work nights, weekends, and holidays as required. Ability to work with very minimum supervision and work on complex issues. Must be proactive. Must have a good attitude regarding safety and lock out procedures. Technical school education in the areas of Manufacturing Engineer, Mechanical Engineering Technology, Electrical Engineering Technology or 6+ years equivalent education/experience. Proven experience in machine maintenance and troubleshooting skills. Good understanding of GMPs with experience in pharmaceutical environment. Read and understand mechanical and assembly drawings, hydraulic/pneumatic, and electrical schematics. Read and understand P&ID (Piping and Instrumentation Diagram). Occasionally lift and/or move up to 50 pounds. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI=MG1