Scientist I, Process Development - Downstream

Location
Durham, NC, US
Posted
Apr 21, 2021
Ref
5979
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 Scientist I, Process Development - Downstream, is a technical lead that supports laboratory operations in process design, experimental design and execution, scale model development and management, investigational testing for manufacturing operations support, platform development project planning and execution and therapeutic product program development support. Laboratory operations support process development activities for drug substance (upstream, intermediate and downstream), drug product (formulation, filling, packaging and labeling) and critical raw materials, as well as media and buffer manufacturing.

Responsibilities
  • Plans, executes and documents experimental procedures and complex studies in support of process development activities supporting investigational, clinical and commercial gene therapy programs.
  • Process development activities include but are 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 and improvement studies.
  • Collaborates in multiple technical development areas.
  • Advances complex downstream process development efforts as a technical lead within a cross-functional team across sites.
  • Leads projects within the downstream unit to enhance manufacturing AAV purification technologies, capabilities, and processes.
  • Plans, designs, executes and interprets complex development studies (with multiple experiment sets) related to process development and scale-up, ensuring studies 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 and PAR setting, CPP edge of failure, impurity clearance performance).
  • Author 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 experimental data from process studies aimed at building fundamental process understanding.
  • Troubleshoots scientific and technical challenges, and contributes to 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.
  • May advise on the activity of scientific and engineering staff.
  • Other related job duties as assigned.

Qualifications
  • Bachelor's with 4 years' experience or Master's with 2 years' experience or PHD with 0 years' experience.
  • Demonstrated experience with experimental design, execution, and interpretation (Design of Experiment a plus) that drives downstream project progress and with laboratory biosafety practices. Lean laboratory implementation (e.g. 6S) a plus.
  • Comprehensive and highly experienced with a variety of biopharmaceutical purification processes such as chromatography, depth filtration, precipitation and flocculation, tangential flow filtration, adventitious viral clearance, ultracentrifugation, and impurity clearance.
  • Comprehensive and highly experienced in the laboratory setting with single use and automated systems (e.g. Mobius, AKTA)
  • Knowledge and understanding of viral particle purification in clinical and commercial manufacturing settings, direct experience in those environments highly preferred.
  • In-depth knowledge of AAV development including empty/full capsid separation development, scale-up, and increasing step yield performance preferred.
  • Comprehensive experience and expertise in how to scale-up and down biopharmaceutical processes, including developing and leveraging scale models.
  • 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, specifically within the downstrem context.
  • Technical downstream lead, and participation on, complex, multi-disciplinary technical teams of scientists and engineers tasked with rapid and comprehensive development of new biopharmaceutical manufacturing platforms.
  • 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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