Scientist II, Process Development - Upstream

Durham, NC, US
Nov 21, 2020
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

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.

The Scientist II, Process Development - Upstream, supports laboratory operations in process design, experimental design & execution, scale model development & management, investigational testing for manufacturing operations support, platform development project planning & execution and therapeutic product program development support.

  • Executes and documents experimental procedures in support of process development activities supporting investigational, clinical and commercial gene therapy programs including but not limited to new process design, process proof of concept through characterization studies in alignment with program strategy, pre-clinical materials generation, direct clinical and commercial GMP operations support, scale-up studies scale model demonstration through qualification, raw materials and process pool evaluations in addition to process optimization & improvement studies.
  • Supports process development activities in drug substance (upstream, intermediate and downstream), drug product (formulation, filling, packaging and labeling) and critical raw materials, as well as media and buffer manufacturing and as a result individuals have opportunity to collaborate in the multiple technical development areas.
  • Advises on the activity of scientific and engineering staff.
  • Participates in upstream process development efforts under the direction of a cross-functional team.
  • Executes projects within the upstream unit to enhance AAV production and capture technology capability and performance.
  • Under the direction of senior colleagues and individual manager, executes development studies related to process development and scale-up.
  • Drives results and generates innovative solutions, takes accountability to actively support solving scientific problems and driving their resolution.
  • Supports active pre-clinical, clinical and commercial manufacturing through laboratory studies designed to illuminate fundamental process performance (e.g. NOR & PAR setting, CPP edge of failure, impurity clearance performance).
  • Participates in the authoring of technical reports of studies in support of process development activities such as Tech Transfer, unit operation design through characterization and Quality attribute impact assessments.
  • Ensures all documentation and reports are accurate, complete, and suitable for use in support of platform development summary reporting, manufacturing records development as well as Quality investigations and regulatory dossiers.
  • Analyzes and interprets data to understand the fundamental phenomena at the heart of the investigation at hand and inform next steps.
  • Troubleshoots scientific and technical challenges, and contributes to their resolution.
  • Fosters a team environment committed to the principles of scientific excellence.
  • Completes requisite training, as well as applicable policies and procedures, related to the job function.
  • Other related job duties as assigned.

  • Bachelor's with 6 years' experience or Master's with 4 years' experience or PHD with 2 years' experience.
  • Experience in chemistry, analytical chemistry, molecular biology, biochemistry, chemical engineering, bioengineering or a related technical field.
  • Understanding of Design of Experiment principles, basic knowledge of lean laboratory implementation (e.g. 6S) and exposure to laboratory biosafety practices.
  • Experience with a variety of mammalian cell culture bioreactor technologies, adherent and suspension, including fed batch and perfusion.
  • Experience in the laboratory setting with single use and automated bioreactors (e.g. AMBR 250).
  • Knowledge and understanding of cell culture in clinical and commercial manufacturing settings, direct experience in those environments preferred.
  • Limited experience with and/or basic knowledge of biopharmaceutical purification processes such as chromatographic separation, depth filtration, precipitation & flocculation, tangential flow filtration, adventitious viral clearance, ultracentrifugation, and impurity clearance.
  • Knowledge of viral particle production and capture in clinical and commercial manufacturing settings, direct experience in those environments preferred.
  • Working knowledge of or familiarity with scale models of biopharmaceutical processes.
  • Familiar with global regulations pertaining to cGMP manufacturing of biopharmaceuticals.
  • May require up to 25% travel.

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.