Scientist, Analytical Science and Technology Job at Innovative Medicines, Durham, NC

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  • Innovative Medicines
  • Durham, NC

Job Description

Summary

-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.   Novartis is unable to offer relocation for this role: please only apply if this location is accessible for you.

About the Role

Summary:

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

Responsibilities:

  • Leads method transfer, qualification/validation, trending across analytical network.
  • Performs lab experiments with oversight/guidance.
  • Acts as analytical technical lead for one or more projects with guidance.
  • Works closely with Analytical Development group to transfer/co-qualify new methods.
  • Collaborate with internal and external testing labs to ensure successful completion of projects to the organizations' standards.
  • Assists with authoring experimental protocols/reports and regulatory submissions related to analytical.
  • Participates in assay troubleshooting and projects to improve method performance across network.
  • Supports OOS investigation and other non-conforming results and implement appropriate corrective and preventative actions.
  • Assists with responses to agency questions related to analytical methods/specification.
  • Other related QC and AS&T duties as assigned.

Requirements:

  • BS, in a relevant concentration with 6 years’ biopharmaceutical experience; MS with 4 years’ biopharmaceutical experience; Ph.D. with 1 year biopharmaceutical experience.
  • Strong critical thinking and problem-solving skills.
  • Experience with method development, transfer, qualification, and validation.
  • Experience in gene/cell therapy field is a plus.
  • 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.
  • Energetic, flexible, collaborative, and proactive.
  • Strong communication, scientific writing, and presentation skills.

The pay range for this position at commencement of employment is expected to be between $92,800 and $139,200 annual; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:

Accessibility and Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

Job Tags

Relocation, Relocation bonus, Flexible hours,

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