Scientist II, Analytical Chemistry

Employer
AveXis Inc.
Location
San Diego, CA, US
Posted
Oct 12, 2019
Ref
2019-4204
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
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.

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