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Director, Quality Control- Gene Therapy Manufacturing

Expired Job

Avexis Libertyville , IL 60092

Posted 2 months ago

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. 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.

The Director, Quality Control is responsible for the organization, administration and control of all quality control functions of the company. Responsibility includes (i) ensuring that the company's products meet all relevant quality standards, including the company's own high quality standards, (ii) leading and overseeing the company's Quality Control group, (iii) managing the company's quality control program, and (iv) establishing and maintaining appropriate Quality Control processes, policies and standard operating procedures to achieve the company's objectives. Sets the strategic direction for the QC department.

Responsibilities

  • Develops organizational structure and fosters talent management, including performance and succession planning, to support the company's business objectives

  • Develops functional capabilities within the department to keep pace with advances in technology and company growth

  • Creates a safe and dynamic work environment that supports an innovative, efficient and flexible organization

  • Fosters a culture of compliance and excellence in quality throughout the company

  • Develops departmental expertise with respect to testing and documentation that may be required to satisfy legal and regulatory requirements for products

  • Develops cooperative and strong working relationships with Manufacturing, Quality Assurance and MS&T to achieve company objectives

  • Develops and coordinates the Quality Control laboratory activities and capabilities to provide timely, accurate and cGMP compliant testing of raw materials, in-process materials, bulk and contract manufactured materials

  • Guides the activities of the Quality Control group to ensure that the company has a robust product stability programs for domestic and international products

  • Oversees the approval of all specifications, procedures and formulas that impact the strength, quality, purity, and efficacy of manufactured and contract-manufactured products

  • Ensures the proper investigation into the root cause of product and/or process failures, and assists in determining appropriate product disposition and/or process improvements

  • Ensures that any internal and external laboratories comply with GMP standards

  • Collaborates with MS&T and/or outside contract labs to ensure seamless method validation and transfer

  • Participates in business sub-teams as a Subject Matter Expert (SME) to provide input on timeliness and to address analytical/microbiological related issues

  • Designs and implements labs at manufacturing facilities

  • Has responsibility for Method Development, Qualification and Validation

  • Responsible for routine testing and generation of Certificate of Analysis

Qualifications

  • Bachelor's Degree in Chemistry, Biology or related sciences

  • Minimum 10 years of experience in pharmaceutical testing laboratory

  • 5+ years of direct supervisory experience

  • Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes team work, collaboration, influencing, motivating, and consensus and team building

  • Strong strategic thinker with business acumen

  • Good critical thinking, deductive reasoning, and decision making skills

  • Strong problem solving skills

  • Comprehensive knowledge of chemical and microbial analysis, manufacturing operations, GMP's and the theories and general principles behind them

  • Comprehensive knowledge of compliance with cGMP regulations

  • Understanding of laboratory equipment such as ddPCR, qPCR, UPLC/HPLC, ICP-MS, UV/Vis Spectrophotometer, Densitometer, Gel Imager, pH, Osmometer, etc

  • Understanding and experience with relevant analytical and microbiological testing, methods development/validation, and environmental monitoring programs required to meet all regulatory requirements

  • Experience with LIMS implementation preferred

  • Strong project management skills

  • Training in and practical experience with Six Sigma a plus

  • Approximately 10% travel required

This position will be located out of our Manufacturing site located in Libertyville IL.

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.


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Director, Quality Control- Gene Therapy Manufacturing

Expired Job

Avexis