Scientist I, Process Development - Analytical

Location
Durham, NC, US
Posted
Sep 18, 2020
Ref
5585
Hotbed
Bio NC
Required Education
Bachelors Degree
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? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

Scientist I, Process Development - Analytical, is responsible for developing and optimizing phase-appropriate analytical assays used for testing and characterization of drug substance/drug product as well as in-process pool product quality attribute and concentration testing.

Responsibilities
  • Provides analytical testing support across the entire process (e.g. upstream, downstream, drug product) in support of exploratory studies targeted at developing, demonstrating and characterizing new technology platforms and innovative upgrades for existing platforms.
  • Perform analytical method development, transfer and testing support in the TR&D laboratory
  • Work with QC and/or Analytical Sciences group to transfer analytical methods into TR&D lab
  • Perform in-process and drug substance/drug product assays.
  • Design, perform, and guide lab experiments in support of AAV process development and process characterization studies using some of the following techniques: ddPCR, qPCR, ELISA, analytical ultracentrifugation, spectrophotometry, particle analysis, HPLC, CE, SDS-PAGE, and Western blot.
  • Author experimental protocols/reports and related to analytical methods
  • Participate in assay troubleshooting and method performance improvement projects
  • Represent TR&D laboratory in cross-functional teams (QC, Analytical Sciences, Technical Development, Manufacturing Sciences and Technology, etc.)
  • Collaborate with contract testing labs to ensure successful completion of testing projects
  • Manage the use and maintenance of scientific equipment and instrumentation, computer systems
  • Support test sample forecasting, submission, progress tracking, and results reporting
  • Participate in exploratory assay development efforts to bring new technologies or assays to the Analytical Development department.
  • Other related job duties as assigned.

Qualifications
  • Bachelor's in chemistry, analytical chemistry, molecular biology, biochemistry or a related technical field with 4 years experience or Master's with 2 or PHD with 0.
  • Experience, with knowledge and hands-on experience with various analytical methods including but not limited to, ddPCR, qPCR, Western Blot, ELISA, MSD, ELISpot, Flow HPLC, Capillary Electrophoresis, Cytometry/FACS, Luminescence/Fluorescence plate-based assays, Immunofluorescence microscopy.
  • Demonstrated proficiency in developing and optimizing assays independently with limited guidance by more senior scientists.
  • Demonstrated ability to work in a fast-paced, team-orientated environment with aggressive timelines.
  • Excellent written and verbal communication skills.
  • Experience and understanding of phase-appropriate analytical assay development, qualification, and validation in GxP environments is preferred.
  • Experience with analytical and/or statistical software (e.g., JMP, Softmax Pro, XLfit, Gen5 etc.), preferred.
  • Ability to troubleshoot experiments based on thorough understanding of assay principles.


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.

Novartis Gene Therapies 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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