Senior Scientist, Process Development - Upstream

Location
Durham, NC, US
Posted
Apr 21, 2021
Ref
5976
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

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.

The Senior Scientist, Process Development - Upstream, leads laboratory operations in process design, experimental design & execution, scale model development and management, investigational testing for manufacturing operations support, platform development project planning, execution, and therapeutic product program development. In addition, the Senior Scientist engages with 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.

Responsibilities
  • 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.
  • Advises on, and as needed directs, the activity of scientific & engineering staff.
  • Advances complex upstream process development efforts as a technical lead within a cross-functional team across AveXis sites.
  • Leads projects within the upstream unit to enhance AAV production and capture technology capability and performance.
  • Independently designs and executes development studies related to process development and scale-up, ensuring individual experiments balance time and resources.
  • Drives results and generates innovative solutions, takes independent action to solve scientific problems and drive 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).
  • Independently authors 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, contributes to and/or leads their resolution.
  • Leads and mentors junior colleagues while fostering 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.

Qualifications
  • Bachelor's with 8 years' experience or Master's with 6 years' experience or PHD with 4 years' experience.
  • Experience in chemistry, analytical chemistry, molecular biology, biochemistry, chemical engineering, bioengineering or a related technical field.
  • Expert knowledge of scientific principles and concepts. Reputation as emerging leader in field with sustained performance and accomplishment.
  • In-depth knowledge of AAV development including transfection development, scale-up, and significantly improving process performance preferred.
  • Extensive 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).
  • In-depth knowledge and understanding of cell culture in clinical and commercial manufacturing settings, direct experience in those environments preferred.
  • Experience in how to develop, optimize, and leverage scale models of biopharmaceutical processes. Advanced understanding of macroscopic kinetic models of mammalian cells preferred.
  • Understanding of, and experience with, global regulations pertaining to cGMP manufacturing of Drug Substance and/or Drug Product and the translation of those regulations into process development work products.
  • Indirect and direct leadership of, and participation on, complex, multi-disciplinary technical teams of scientists and engineers tasked with rapid and comprehensive development of new biopharmaceutical manufacturing platforms.
  • Demonstrated experience with Design of Experiment, lean laboratory implementation (e.g. 6S) and laboratory biosafety practices.
  • Expert knowledge of scientific principles and concepts. Reputation as emerging leader in field with sustained performance and accomplishment.
  • May require up to 25% travel.


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.

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