40 jobs found in Libertyville

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. In this role you will be responsible for the day to day oversight of the Quality Control Microbiology team. You will also be responsible for the environmental monitoring program, raw material testing, in-process and final product testing. Responsibilities Manage all Quality Control Micro laboratory testing and team. Manage performance for the team, including goal setting and monitoring, ongoing feedback and performance evaluations. Manage sample receipt, retain storage and disposal. Sustain environmental monitoring program for AveXis. Management and optimization of the Aseptic gowning training and qualification program. Management of Quality Control Microbiology training program, develop training materials and continue to improve existing program. Work with QC raw materials team to establish specifications and testing process of raw materials. SME on investigations of sterility and environmental excursions. Monitor and trend data. Assemble reports on findings from environmental monitoring of AveXis's cGMP facility. Frequently update management on environmental trends. Implement corrective action plans when necessary. Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release. Develop, revise and review SOPs, qualification/validation protocols and reports. Conduct investigations regarding out of specifications (OOS) results and address and manage non-conformances related to micro/cell culture procedures. Provide updates at daily and weekly meetings. Monitor the GMP systems currently in place to ensure compliance with documented policies. Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate. Gather metric information for use in continuous improvement of areas of responsibility. Other duties as assigned. Qualifications Bachelor's degree or advanced degree in Microbiology or related discipline. Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment. A minimum of 10 years' experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required. A minimum of 3 years' experience supervising/managing microbiology and environmental monitoring labs within the biotechnology or pharmaceutical industry. The ideal candidate is well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes. Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes. The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, on an as-needed. Strong knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211). Strong knowledge of GMP, SOPs and quality control processes. Strong data integrity knowledge and practices. Identifying, writing evaluating and closing OOS's and investigations. Strong knowledge of contamination control, disinfection, cleanroom design and operation, aseptic techniques. Equipment and utility IQ/OQ/PQ/PV. Proficient in MS Word, Excel, Power Point and other applications. Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment. Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Flexibility to work weekends/overtime as needed. Must be capable of bending, lifting, moving and/or carrying up to approximately 25 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. #L1-GK1

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. In this position, the incumbent will drive awareness and own change management activities at the site level to champion and ensure a culture of Data Integrity Excellence. This individual will drive and monitor site progress against the Data Integrity Plan, oversee site implementation of corrective and preventative measures (CAPAs) and related mitigation of risks. In addition, this position must assure appropriate systems and processes to support GxP data integrity. Responsibilities Establish and manage all site DI topics. Serve as the site subject matter expert for all DI-related inquiries/trainings and DI assessment tools. Identify and maintain a network of functional Data Integrity (DI) Subject Matter Experts (SME)/ DI Champions within appropriate GxP functional areas (e.g. Manufacturing, Maintenance, MS&T, engineering, QA Ops, QC, etc.). Determines strategy and collaborates with functional DI SMEs/DI Champions to drive behavioral change management activities to strengthen DI culture. Continuously improve data integrity knowledge base and understanding: Identify training needs and ensure availability of appropriate and functionally relevant training materials; where training does not exist, facilitate creation of material and delivery of training. Create and participate in design and delivery of activities to engage shop floor associates in strengthening quality culture, leveraging network of functional DI SMEs/DI Champions. Drive continuous/sustainable improvement in detecting and mitigating DI risk by working with SMEs to embed DI focus in existing site programs, for example, self-inspection program, continuous improvement program, Gemba walks, etc. Ensure sharing of practices and alignment within stakeholders on key DI topics. Manage DI topics at site in investigations, rapid alerts, reviews and audits related to Data Integrity for both internal Novartis and external parties. Support preparation for regulatory/health authority inspections and/or response development for DI related topics. Facilitate the identification of high-risk data processes and systems (via risk assessment, gap assessment, data mapping, etc.). Identify and champion opportunities for mid and long-term actions and strategies to reduce DI risk. Implementation of DI tools, training materials and guidance (e.g. DI Key cards, Data mapping optimization, audit trail review) at the site according to defined strategy. Conduct site DI training. Drive, monitor and assure delivery of the AveXis DI Plan applicable to your function, including DI communication and engagement plan, and periodically report status/progress to site leadership, AveXis DI lead and Novartis Group Quality as required. Keep aligned with Data Integrity developments across industry, with emphasis on Health Authority developments, and report to management as appropriate. Promote DI reporting aligned with Speak-Up office for DI relevant cases to assure they are managed appropriately across the interface between the Speak-Up office and Quality Investigation and corrective/preventative action processes. Lead DI escalation for any DI related issues. Conduct business reviews at sites to assure progress against DI objectives. Perform site level DI risk assessments as defined per procedural requirements. Represent the site as part of the AveXis DI network/Steering committee. Qualifications Minimum B.S. degree; higher level degree: MS, MBA preferred but not required. At least 8 years' experience supporting manufacturing, quality, and contract supplier/customer interactions; BLA/MAA and PAI experience preferred. At least 3 years of direct industry DI related experience. Experience working in a diverse global SME matrix environment, with ability to drive and manage change. Cross-functional experience in a GxP regulated pharmaceutical industry (e.g Quality Assurance), clinical operations, PV, pre-clinical operations, manufacturing/engineering operations, Quality Management Departments or equivalent external consultant positions with experience in quality risk management through application of ALCOA+ principles and 21CFR Part 11 requirements. Strong operational background preferred. Strong experience in supporting DI programs, risk analysis, project management, budget, communication and presentation skills. Ability to synthesize detailed information and provide clear communication and messaging across quality, manufacturing and supply chain. Expert knowledge and understanding of cGXPs Approximately 15% 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-GK1

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 Quality Assurance Engineer is responsible for quality oversight of the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at the Durham AveXis site. The position will provide experience and expertise to transition a novel gene therapy into a commercially approved product. This individual must have strong knowledge and experience with the application of CFRs and cGMPs and have been involved in regulatory inspections. Experience with comprehensive audit support of all internal and external audits in support of the product manufacture and launch. Responsibilities Quality and Compliance aspects of design working in collaboration with Engineering, technical functions, Manufacturing Operations and outside consultants and contractors to ensure that AveXis' new facility is: Compliant with all appropriate regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing Capable of manufacturing AveXis products that are safe, effective and that meet all applied controls and specifications Capable of meeting intended design goals of output volume, turnaround time and operating and product costs Provide strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters). Contribute to the definition of project plan, control requirements and processes to deliver the new manufacturing facility on time, to required quality and compliance standards and within budget. Contribute to design of facility, utilities and process equipment from a Quality and Compliance perspective. Act as Quality approver on project deliverables, as defined in the project plan. Work with AveXis validation colleagues to define the initial asset life-cycle model and qualification and validation strategy, to ensure successful validation of the facility. Play a lead role in the planning, execution and closure of commissioning, qualification and validation activities from a Quality functional perspective. Author and/or approve Standard Operating Procedures in support of project activity and deliverables. Qualifications Minimum B.S. degree, preferably in engineering or equivalent. A minimum of 2-4 years of directly related experience in biopharmaceutical based GMP manufacturing operations. Experience with viral gene therapies, cell culture technologies 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 with commissioning, qualification and validation to meet FDA and other health authority requirements. 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 participating in internal audits, identify findings, driving to resolution and providing closure report. Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward. Approximately 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. #LI-TM1

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 Vice President, Global Supply Chain has responsibility for leading and coordinating overall AveXis Supply Chain in support of AveXis Technical Operations across the network. Ensures the development and implementation of strategic, tactical, and operational plans for Supply Chain and their seamless cross-functional coordination to meet commercial and clinical requirements, ensure timely supply of gene therapy products and services to markets/patients, and optimize Supply Chain results. Responsibilities Responsible for the development of supply chain management strategic, tactical and operational plans and processes in line with AveXis business strategy Responsible for alignment between supply and demand for short and long term to deliver best service level at targeted cost Responsible for strategy and execution of warehouse and distribution Optimization of global inventories to achieve an agreed service level at an acceptable cost Lead Divisional S&OP processes to support cross-functional management investment decisions Integration of information, physical material and funds flows as part of a global Supply Chain Ensure efficient and effective Supply Chain Business Partnering between Commercial Operations and Technical Operations. Ensure development and implementation of global IT tools are to support the global business Ensure compliance with GMP and regulatory requirements (including record management) and continuous improvement of quality relevant processes within area of responsibility Network effectively across Novartis and wider industry forums to identify future opportunities for collaboration, and to Identify and leverage best practices across the function Build a high performing organization by ensuring the development, success plans, and availability of talent Ensures the integration of all life-cycle elements along entire value chain (particularly launches including new dosage forms, site transfers, production changes, divestment and pruning). Monitors and sustains global inventory, targets and distribution along the value chain including strategic stocks for business continuity. Ensures supply risk management and mitigation plans are in place for identified brands in accordance with Global BC plans and in alignment with global, regional and local stakeholders Monitors supply performance and issues; ensures efficient bottleneck or supply crisis management and facilitates supply allocation in collaboration with the Suppliers and ComOps. Responsible for governing the Supply Chain activity portfolio at their sites by supporting the teams in the definition and execution of the Supply Chain strategies, initiatives, prioritizing and resourcing appropriately, leveraging the Platform Network expertise and capabilities Responsible for implementation of, compliance to and governance of practices specifically prescribed to this role by the Novartis Manufacturing Manual within the Network Qualifications Minimum Bachelor's degree in Engineering, Supply Chain, or related field At least 15 years of experience in managerial capacity in Supply Chain or Head of Supply Unit (Pharmaceuticals, Biopharmacetical or Biotechnology). Demonstrated experience in Global markets Excellent knowledge of Supply Chain business processes within pharmaceutical manufacturing operations, with exposure to both commercial and production Experience in leading cross-functional teams required Strong written and verbal communication skills, including strong presentation development skills. Intercultural experience and ability to act in a complex and rapidly changing business environment Ability to facilitate conversations and drive towards decisions. Ability to influence Ability to work and thrive in a fast paced, rapidly changing environment High performing, credible professional, with a track record of successfully managing projects and achieving results in line with strategic direction. Knowledge of production, quality and regulatory requirements within the pharmaceutical industry and current expectations. 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

Description We believe in diligently working to understand and serve customers to meet their financial security needs. This is why we exist. The Career Basics We're looking for insurance sales agents focused on building a network, finding prospective customers and helping ensure those customers are protected financially in whatever circumstances may arise. We offer insurance sales agents: a competitive compensation plan. In addition to a base salary, you'll be eligible to receive commissions, incentives, trips & rewards. access to benefits like health, vision, dental and disability insurance. We believe before you can help others feel secure, you need to feel that way too! access to the tools you need to serve customers and do successful work, such as a comprehensive training program, marketing and office support. The Ideal Sales Agent At COUNTRY Financial, the ideal insurance sales agent is someone who: proactively communicates with customers and is responsive to their unique needs. values transparency and honesty, always investing in customer relationships. listens to the customer and seeks to understand customers and their families shares their expertise to help educate customers and build trust-especially in new relationships. makes it easy for customers to understand what they're saying and why it matters. Qualifications What You Will Need While these insurance licenses are not required to apply, your ability to obtain them is essential when a hiring decision is made: Property/Casualty State Insurance License* Life/Health State Insurance License* Why Should You Apply? COUNTRY Financial is an organization that is trusted and well-respected in the industry, with a history of success and great ratings. You can make a difference in people's lives while maintaining the flexibility and freedom to do what matters in your own life-we think that's a win. Incredible training from our team will be the first step in your on-boarding process. We want to be sure you're equipped for success! About Us The Organization: COUNTRY Financial® is the trade name for a family of affiliated companies-this means we have a whole family of support and a large backing. Our roots are in agriculture, so we're hardworking and known for the great care we take with customers and employees alike. We are a growing insurance and financial services organization privately serving 19 states across the nation. Our home offices are in Bloomington, IL, with a Southern Office hub in Alpharetta, GA and a Western Office in Salem, OR. Most importantly, we serve over 1 million households in the United States and pride ourselves on putting the customer first. COUNTRY Financial® is an Equal Opportunity Employer . We are committed to provide equal opportunity in all areas of employment and support a diverse workforce and an inclusive work environment.

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 Validation Engineer will assume responsibility for authoring, executing & review/approval of SOP's, commissioning documentation, documents required for validation/qualification such as but not limited to URS, protocols, reports & support records to ensure compliance; timely resolution of documentation, compliance, and quality system issues. Identify, coordinate, execute and provide oversight of validation activities related to the start-up, commissioning, qualification, validation of a cGMP manufacturing facility (including manufacturing equipment, QC lab equipment, utilities). Responsibilities Perform environmental mapping and other miscellaneous validation activities Evaluate and analyze validation data for accuracy and adequacy Support the development of validation execution strategy and timeline for sustained operation within validated GMP environment Collaboratively conduct Risk Assessments and Impact assessments, and establish system boundaries Responsibility for Validation Lifecycle documents including Validation Plans, Impact Assessments, and Validation Reports Review and support IT and Computer Systems Validation efforts for global systems. Manage workload to ensure timely approval of validation testing and documentation. Assist Quality Assurance, Production, Quality Control and other departments during inspections or audits. Additional duties may include attendance at client meetings, preparation of project budgets, review of invoices, and any other duties as required to control financial and execution related aspects of project. Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities. Qualifications BS/MS degree in Chemical, Industrial, Mechanical, or related engineering discipline; or Science with 4-8 years in the pharmaceutical or Biopharmaceutical industry with at least 4 years validation experience. Experience with method and process validation Experience with Biosafety cabinet smoke studies Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities. Experience supporting FDA approved, commercial products. Experience in cGMP environment (IQ, OQ, PQ) is essential Familiar with current industry best practices, including ASTM e2500 to plan efficient/risk-based validation projects Familiarity with validation tools and processes, including environmental mapping and use of Kaye Validator Familiar with GAMP 5 applications and practices 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-JB1

AutoNation Toyota Libertyville Position Summary: The Equity Mining Sales Specialist is responsible for driving incremental sales and acquiring additional inventory for their dealership by actively prospecting our current sales and service databases, as well as identifying conquest customers in our service drives. The Associate will maximize utilization of the Equity Mining Tool (EMT), AutoNations proprietary Equity Mining software, to increase incremental sales and customer retention, while achieving target profit margins and delighting every customer along the way. Lastly, the Associate will align with the service department to achieve these goals without disrupting our service operations or the customer experience. Organizational Relationships: This position interacts daily with Sales & Service Customers, Sales Managers, Service Advisors, Service Director, other associates, Financial Services Manager, and support staff, just to name a few. Job Responsibilities: Leading yourself and in a way that supports AutoNations vision and mission. Driving incremental business through a high-level of involvement in the day-to-day Equity Mining operations. Work with management to identify current promotions and inventory needs. Appraising vehicles for purchase or trade. Executing the appraisal and sales menu presentation process ensuring that Customers understand their vehicle acquisition and replacement purchase options and pricing. Executing the in-service Equity Mining and service drive process in your store. Qualifications: High School diploma, or equivalent. Proven success in auto retail sales, with a focus on equity mining/service customer sales process. Ability to efficiently structure a buy/sell transaction with limited information and customer input. Ability to set and achieve targeted goals. Ability to drive an exceptional Customer experience. Demonstrated communication and interpersonal skills. Organization and follow-up skills. Experience and desire to work with technology. Valid in-state drivers license and have and maintain an acceptable, safe-driving record. Next Possible Position: Sales Manager/Director eCommerce Manager Used Vehicle Manager/Director Financial Services Manager Physical Requirements: 1. Ability to sit and stand for prolonged periods of time. 2. Ability to appraise a vehicle as it sits. 3. Ability to operate an automobile. 4. Exposure to inclement weather. AutoNation is an equal opportunity employer and a drug-free workplace.

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 Summer Intern will assist the Supply Chain Team in one of three areas: Finished drug product distribution Strategic Sourcing Site Purchasing Responsibilities Site Purchasing Track raw materials from time of purchase to time of receipt. Work within the Item Master and update via instruction from the Site Buyer/Planner. Assist Warehouse team with any incoming receipt issues. Participate in weekly meetings with key suppliers Strategic Sourcing Participate in the critical materials meetings and follow up with sites on action items Support the sourcing team on any ongoing sourcing projects possibly performing data analysis, interacting with suppliers Provide project support as needed Distribution Support the distribution team as needed to get drug product to sites of care for clinical studies and commercial doses. Support packaging/shipping validation studies for distribution Support order logistics and customs documents/requirements Qualifications Enrolled in a 4 year program in biochemistry, chemical engineering, bioengineering, finance or business. Excellent oral and written communication skills. 3.0 GPA. Must be able to routinely lift over 35 lbs. 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.

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 overseeing the quality function for the site including the development, implementation, maintenance and overall operation of quality assurance systems and activities and quality control systems. As a member of the Quality leadership team, the Senior Director will represent the site on projects, providing strategic input and recommendations. Responsibilities Develop and lead an effective, efficient Quality team (both Quality Assurance and Quality Control) at an AveXis operating site. Fully responsible for all aspects of Quality Assurance and Quality Control for the site. Fully responsible for key Quality decisions, including Batch Disposition (i.e. Batch release), deviations, change control and complaint investigations. Develop and deliver a robust overall quality systems, strategy, and ultimate plan resulting in a fully compliant facility with respect to procedures and processes. Oversee the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Make recommendations for corrective actions necessary to ensure conformity with quality specifications. Create and lead a monthly Quality Management Review meeting (QMR) attended by senior leadership to review site metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics. Develop strong cooperative working relationships with other site functions (e.g. Manufacturing, MS&T). Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs). Responsible for hiring and training a high-performing quality team to ensure robust quality systems are implemented and sustained, finished products conform to government and company standards and satisfy good manufacturing practices regulations. Participate in external vendor quality audit program. Manage findings, responses and corrections plus lead investigations that involve any raw materials required to manufacture the product. Participate in the development and enforcement of Microbiology laboratory procedures and policies. Participate in the QC Microbiology laboratory strategy and provide oversight of operations. Manage site inspection preparation, management and response process. Selection of manufacturing, testing, and distribution contract suppliers (support audits as needed). Provide quality input during manufacturing runs at CMOs. Ensure all stability studies are designed and executed to enable IND and BLA filings. Successfully design and approve material compatibility experiments of finished goods components. Develop budgets and monitor expenditures. Qualifications Minimum B.S. degree preferably in microbiology, chemistry or biochemistry. A minimum of 12-15 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification, aseptic fill/finish, testing of drug substance and drug product and laboratory operations. Experience with viral gene therapies and/or orphan disease indications is a plus. 5-8 years of direct management experience of Quality professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued guidance, mentorship and support to staff. Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections. Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product related investigations and deviations. Excellent oral and written communication skills with strong technical writing experience required. Experience leading both internal and external vendor audits, identify findings, drive resolution and provide closure report. Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward. Demonstrated ability as a strategic thinker. Strong project management skills and ability to perform long-term project planning, team building, budgeting and operational Six sigma training or practical experience a plus. 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-GK1

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 Automation Engineer provides technical leadership to the automation team at our gene therapy manufacturing facility. Responsibilities Lead the design, configuration, installation, and maintenance of automation software (SCADA) and associated hardware; including interacting with other teams as necessary. Provide oversight or participation on all automation aspects of future projects including integration of 3rd party equipment to the plant SCADA and BMS systems, data concentration, batch reporting, and data retention. Maintains, troubleshoots and modifies the GMP and non-GMP control systems; Systems may include plant wide SCADA, BMS, 3 rd party local control systems, freezers, air handlers and chillers. Prepare scopes of work and manage automation contractors as required to complete required work on within project timelines. Develop project objectives working with user requirement and business plans. Finish Determine equipment or system specifications and most cost-effective technology to be implemented. Participate in discussions with internal business partners on priorities, timelines and transparent sharing of information. Establish equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS). Take programs from concept thru execution while managing all stages in the process utilizing a strong set of project management tools. Responsible for maintaining procedures to meet GMP requirements, CFR's and internal company policies. Participate and/or lead new product implementation product transition processes to ensure smooth transition from process development into GMP manufacturing. Drive operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Problem solve any technically related issues impacting production. Support 24x7 site-based operations after startup. Create and update procedures to drive operational efficiency and compliance. Implement and revise SOPs to conform with standards and policies. Deploy, maintain, and upgrade manufacturing applications. Perform investigations of non-conformances related to automation systems. Analyze and interpret data and make sound technical recommendations on continuous improvements and non-conformance remediations. Execute change controls to update and upgrade automation systems and equipment. Qualifications BS. degree in Engineering, Computer Science, or related technical field. 8 years of experience in biotech or pharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish. Experience programming, troubleshooting, and maintaining site SCADA/HMI systems (e.g. FactoryTalk View SE, iFix, Wonderware, Emerson/DeltaV). Experience programming, troubleshooting, and maintaining site PLC/BMS systems (e.g. ControlLogix, Siemens TIA/S7). Experience programming, troubleshooting, and maintaining site data historian (e.g. FactoryTalk Historian). Experience in system level validation testing. Proven experience applying S88 in an automated environment. Working knowledge of field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation. Knowledge of industrial communication protocols such as MODBUS, Ethernet IP, etc. Experience writing and executing change controls. Able to develop MS SQL queries. In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems. Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high quality driven processes and end products. Excellent oral and written communication skills. Experience managing 3 rd parties (both in-sourcing and outsourcing). Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning. Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere. Provide technical support on all manufacturing issues when driving towards issue resolution. 10 - 50% travel may be required. This position will be located out of our Libertyville IL office. 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

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-AR1

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 overseeing the quality function for the site including the development, implementation, maintenance and overall operation of quality assurance systems and activities and quality control systems. As a member of the Quality leadership team, the Senior Director will represent the site on projects, providing strategic input and recommendations. Responsibilities Develop and lead an effective, efficient Quality team (both Quality Assurance and Quality Control) at an AveXis operating site. Fully responsible for all aspects of Quality Assurance and Quality Control for the site. Fully responsible for key Quality decisions, including Batch Disposition (i.e. Batch release), deviations, change control and complaint investigations. Develop and deliver a robust overall quality systems, strategy, and ultimate plan resulting in a fully compliant facility with respect to procedures and processes. Oversee the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Make recommendations for corrective actions necessary to ensure conformity with quality specifications. Create and lead a monthly Quality Management Review meeting (QMR) attended by senior leadership to review site metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics. Develop strong cooperative working relationships with other site functions (e.g. Manufacturing, MS&T). Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs). Responsible for hiring and training a high-performing quality team to ensure robust quality systems are implemented and sustained, finished products conform to government and company standards and satisfy good manufacturing practices regulations. Participate in external vendor quality audit program. Manage findings, responses and corrections plus lead investigations that involve any raw materials required to manufacture the product. Participate in the development and enforcement of Microbiology laboratory procedures and policies. Participate in the QC Microbiology laboratory strategy and provide oversight of operations. Manage site inspection preparation, management and response process. Selection of manufacturing, testing, and distribution contract suppliers (support audits as needed). Provide quality input during manufacturing runs at CMOs. Ensure all stability studies are designed and executed to enable IND and BLA filings. Successfully design and approve material compatibility experiments of finished goods components. Develop budgets and monitor expenditures. Qualifications Minimum B.S. degree preferably in microbiology, chemistry or biochemistry. A minimum of 12-15 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification, aseptic fill/finish, testing of drug substance and drug product and laboratory operations. Experience with viral gene therapies and/or orphan disease indications is a plus. 5-8 years of direct management experience of Quality professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued guidance, mentorship and support to staff. Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections. Direct experience reviewing and/or authoring CMC sections of regulatory filings and partnering with operations on product related investigations and deviations. Excellent oral and written communication skills with strong technical writing experience required. Experience leading both internal and external vendor audits, identify findings, drive resolution and provide closure report. Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward. Demonstrated ability as a strategic thinker. Strong project management skills and ability to perform long-term project planning, team building, budgeting and operational Six sigma training or practical experience a plus. 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-GK1

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-AR1

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 BioProcess Engineer is responsible organizing, running, sustaining, and continuously improving the manufacturing operations process at the plant/site. This individual will work on the manufacturing floor to produce product, troubleshoot equipment, help drive process improvements, error proof the process, investigate deviations, and provide ownership for specific pieces of processing equipment. Responsibilities Produce clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs. Support the product requirements to ensure that all products are produced according to plan. Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed. Participate in information requests for FDA and internal audits of the manufacturing facilities. Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies directly related to the manufacturing process. Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing. Look for opportunities to implement operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Assist the technical operations team to resolve any issues related to production. Qualifications 2-4 years' experience in Biological Manufacturing environment. Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience. Excellent oral and written communication skills. Preferred: 2-4 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish with working knowledge of FDA regulations and GMP systems, strong technical writing ability and proven ability to effectively lead and participate on teams. 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