Manager, Quality Control BioAssay (cGMP Commercial)

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 Manager, Quality Control - BioAssay will oversee testing and support the design and development of tests, studies, procedures, and specifications for the AveXis pre-clinical, clinical, and commercial material programs. This includes cGMP release testing using a cell-based potency assay. This position will lead a group of staff who will have expertise in execution of analytical testing.

Responsibilities

• Oversees/manages commercial testing labs and works closely with manufacturing organizations.
• Lead the development, qualification, validation, and transfer of analytical methods.
• Interpret product release and stability data.
• Participate in establishment / revision of drug substance and drug product specifications for IND, IMPD, and BLA submissions.
• Work closely with the regulatory team to provide analytical documentation to the FDA and international regulatory agencies during regulatory submissions.
• Act as the subject matter expert for investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
• Author protocols, reports, and analytical sections of regulatory submissions (IND, IMPD, BLA).
• Recruits, develops and mentors staff and provides support to ensure successful accomplishment of business goals.
• Perform other related duties as assigned.

Qualifications

• Bachelor's Degree in Chemistry, Biology or related sciences.
• Minimum 8 years of relevant experience in pharmaceutical testing laboratory and 2 years prior leadership experience.
• Strong working knowledge of protein chemistry and analytical test methodologies: cell-based potency assays.
• Prior experience with biologics, QC, stability, IND submissions, BLA or NDA submissions is important for success in the position.
• Understanding of applicable USP, ICH, and Ph Eur regulations as they relate to QC testing is also highly desirable.
• Expertise in use of Excel or comparable software solutions for management and analysis of data.
• Outstanding problem-solving abilities.
• Ability to work independently and effectively.
• Ability to prioritize and deliver on tight timelines.
• 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.
• Good critical thinking, deductive reasoning, and decision-making skills.
• Approximately 10% 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.

#LI-GK1