Scientist II, Analytical Development - Chem

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 Scientist II, Analytical Development - Chem, Develops/optimizes innovative analytical methods suitable for characterization and lot release of gene therapy products, participate in assay qualification/validation/transfer under cGMP requirements. Serve as SME to support regulatory commitments, IND filings and manufacturing process development and validation.

Responsibilities

• Performs analytical chemistry research to develop/optimize HPLC, CE and MS based analytical assays for the characterization and lot release/stability monitoring of gene therapy products.
• Qualifies/validates and transfers testing methodology used for manufacturing production in-process control and final drug substances/drug products, under cGMP settings.
• Conducts testing of analytical samples in support of regulatory commitments, IND flings and manufacturing process characterization/validation.
• Conducts work in compliance with cGMP, safety and regulatory requirements.
• Provides analysis and evaluation of material and products at all stages of development process.
• Monitors and evaluates completion of tasks and projects.
• Initiates, directs and executes chemistry efforts and strategies in research and/or development; also, plans and executes laboratory research.
• Maintains broad knowledge of state-of-the-art principles and theories in analytical chemistry, protein chemistry, DNA chemistry and related disciplines.
• Makes major contributions to scientific literature and conferences.
• Serves as in-house and outside consultant.
• May act as spokesperson on corporate research and development of patent applications (this may be very rare).
• Interfaces with various departments, serves as liaison among different functional groups for scientific discussions and analytical results presentation.
• Proactively identifies assay issues, new assay needs and provide scientific suggestions and solutions.
• Authors/reviews SOPs, working instructions, technical protocols/reports.
• 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 participates and give suggestions on lab designing, instrument purchasing and strategic planning.
• Other related job duties as assigned.

Qualifications

• Bachelor's in Analytical Chemistry or closely related field, with 6 years experience or Master's with 4 years experience or PHD with 2 years experience.
• Expert knowledge of scientific principles and concepts.
• Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Expert knowledge of scientific principles and concepts.
• Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
• Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Normally receives no instructions on routine work, general instructions on new assignments.
• Brings together a variety of backgrounds, combining analytical chemistry, biochemistry, biochemical engineering, protein chemistry and PhD expertise.
• Skilled in cutting edge analytical techniques, including but not limited to HPLC, CE, FFF, Light scattering, spectroscopy and MS.
• Good working knowledge on analytical software including but not limited to Chromeleon, Empower, Chemstation, Astra, 32Karat, Xcalibur, Mascot, Byonic.
• Good working practice and understanding on data integrity and compliance.

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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