Senior Scientist, Analytical Development

Employer
AveXis Inc.
Location
San Diego, CA, US
Posted
Nov 27, 2018
Ref
2018-2737
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

AveXis is seeking an experienced and exceptional Senior Scientist to join the dynamic and growing analytical team to establish analytical methods suitable for lot disposition and characterization of gene therapy drug products and substances.

He/she will be mainly responsible for the analytical method development, qualification and validation under phase-appropriate GMP and will also be part of method transfer and training team for successful transfer of the in-house qualified or validated assay to internal or external QC laboratories under the guidance by his/her supervisor. The individual will have the ability to mentor/train junior group members to ensure appropriate and effective experimental design, execution, data interpretation and trouble-shooting. Responsibilities will also include authoring tech reports, SOPs and qualification/validation protocols and reports, with minimum guidance. The role will involve laboratory work and provide representation of chemistry team on the cross-functional teams.

Responsibilities

  • Independently develop, optimize and qualify/validate HPLC, CE, FFF based analytical methods suitable for gene therapy characterization, lot release and stability study based on thorough understanding of the scientific background of the products.
  • Proactively identify assay issues, new assay needs and provide scientific suggestions and solutions.
  • Serve as SME to work with CROs for method development/qualification/validation, actively participate in the scientific discussion and provide input/feedback.
  • Work closely with functional groups (for example, R&D, QC/QA and manufacturing groups) to ensure win-win collaboration in developing/transferring analytical methods suitable for characterization, stability, and release testing purpose.
  • Effectively communicate results both internally and externally by presentations or written reports.
  • With minimum guidance, author/review SOPs and technical protocols/reports; contribute to data generation/interpretation/summarization in support of regulatory filings including IND and BLA.
  • Mentor/guide junior group members on daily laboratory work, experimental design, data interpretation and troubleshooting. Train new group members on basic analytical lab skills.
  • Actively participate and give suggestions on lab designing, instrumentation purchasing and strategic planning.


Qualifications

  • Ph.D. or M.S. in analytical chemistry or related scientific discipline is required. 5-8 years (Ph.D) or 8-10 years (M.S) of biopharma industry experience is required.
  • Extensive knowledge and experience with a broad spectrum of analytical techniques (including but not limited to SEC, FFF, IEC, RP-HPLC, CE-SDS, iCIEF, MALS, DLS) for lot disposition and characterization of biologics drug product candidates.
  • In-depth understanding and troubleshooting capability of analytical instrumentation and software (including but not limited to HPLC, CE, FFF, MALS, DLS, Chromeleon, Empower, Chemstation, Astra, 32 Karat).
  • Previous working knowledge on mass spectrometry (MS) characterization of protein therapeutics is a plus.
  • Working experience on antibodies, vaccines or gene therapy drugs are required
  • Strong technical writing skills and experience in authoring development reports and SOPs with detail-oriented trait.
  • 1-3 years of GxP experience in qualifying and/or validating analytical assays is preferred.
  • Highly motivated, hard-working and detail oriented. Strong ability to work in a fast-paced team environment with highly goal-oriented approaches and to prioritize work from multiple projects with can-do attitude is required.
  • Ability to proactively bring in and assess value-added platforms based on special needs associated with characterization of the gene therapy drug products is essential.
  • Excellent written and verbal communication skills.

Other responsibilities:

This position is located out of our La Jolla area facility and may require up to 10% travel between La Jolla, third party vendors (domestic) and our HQ and Manufacturing sites located in the Chicago area.

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.