Scientist II, Process Development - Analytical

Durham, NC, US
Jul 10, 2021
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

Scientist II, 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.

  • 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.

  • Bachelor's in chemistry, analytical chemistry, molecular biology, biochemistry or a related technical field with 6 years experience or Master's with 4 or PHD with 2.
  • Expert knowledge of scientific principles and concepts.
  • Experience, with knowledge and hands-on development with various analytical methods including but not limited to, ddPCR, qPCR, Western Blot, ELISA, HPLC, Capillary Electrophoresis, MSD, ELISpot, Flow 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.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

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.