Band
Level 3Job Description Summary
The Analytical Science and Technology (AST) Scientist leads activities for analytical method transfer development and optimization qualification validation troubleshooting and investigation.Job Description
Location: This position will be located in Durham NC and is a full time onsite role.
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Major Accountabilities:
Leads method transfer qualification/validation trending across analytical network.
Performs lab experiments for troubleshooting development and validation efforts.
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.
Skills:
Quality environment
Business Partnering
Operational Excellence
Risk Management
Stakeholder Management
Collaboration
Regulatory requirements knowledge
Dealing with ambiguity
Problem Solving Skills
Leadership
Communication skills
Data Integrity
Digital savviness
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $85400 and $158600 per year.
The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
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 call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Agility Audit Management Business Partnering Change Control Continued Learning Health Authorities Influencing Skills Knowledge Of Capa Qa (Quality Assurance) Quality Management Quality Management Systems (QMS) Risk Management Root Cause Analysis (RCA) Self-Awareness Sop (Standard Operating Procedure) Technological ExpertiseRequired Experience:
IC
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.