Scientist, Analytical Science and Technology (Remote)

Location
Durham, NC
Posted
Oct 12, 2021
Ref
2021-6340
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

Imagine… 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 Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

 

We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia.

 

Imagine the lives you could transform by joining the Novartis Gene Therapy team.

 

The Analytical Science and Technology (AST) Scientist provides support for analytical method transfer, development and optimization, qualification, validation, troubleshooting and investigation.

As gene therapy is still an emerging/fast progressing field, passion for continuous learning and capability to work in a highly dynamic, fast pace, collaborative environment is key to the success of this role.

Responsibilities

  • Perform lab experiments with oversight/guidance.
  • Oversee method transfer, qualification/validation, trending across analytical network.
  • Act as analytical technical lead for one or more projects with guidance.
  • Work closely with Analytical Development group to transfer/co-qualify new methods.
  • Collaborate with contract testing labs to ensure successful completion of projects to the standards of Novartis Gene Therapies.
  • Assist with authoring experimental protocols/reports and regulatory submissions related to analytical.
  • Participate in assay troubleshooting and projects to improve method performance across network.
  • Support OOS investigation and other non-conforming results and implement appropriate corrective and preventative actions.
  • Assist with responses to agency questions related to analytical methods/specification.
  • Manage the use and maintenance of scientific equipment and instrumentation, computer systems.

Qualifications

  • BS with 4+ years' biopharmaceutical experience; MS with 2+ years' biopharmaceutical experience; Ph.D.
  • Strong critical thinking and problem-solving skills.
  • Experience with method development, transfer, qualification and validation.
  • Experience in gene/cell therapy field is a plus.
  • Must possess knowledge of some of the following: general protein/nucleic acid chemistry/biochemistry, basic molecular biology, basic understanding of GMP requirement and regulations (FDA/EMA/ICH etc.), Chromatography (RP, SEC, IEX, HILIC etc.), ELISA, cell based bioassay (potency, infectious titer assay etc.), PCR (qPCR, ddPCR etc.), analytical ultracentrifugation, spectroscopy (UV, fluorescence, FTIR), mass spectrometry (esp. ICP-MS), particle analysis.
  • An excellent and persuasive communicator.
  • Energetic, flexible, collaborative and proactive.
  • Strong communication, scientific writing and presentation skills.

 

 

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. #LI-MG1

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