Scientist / Principal Scientist Quality Control

Job Description Summary

The Scientist / Principal Scientist provides technical leadership and site support for current and future Quality Control operations within Novartis which may The Scientist / Principal Scientist provides technical leadership and site support for current and future Quality Control operations within Novartis which may include analytical method lifecycle management, including method transfer, development, qualification, validation, testing, release, troubleshooting, and specification strategy. This role supports new and ongoing project support for regulatory submissions, QC operations, and cross-functional initiatives across sites.

Location : Durham #LI-Onsite

This role is located on-site in Durham, NC. Novartis is unable to offer relocation support for this role; please only apply if this location is accessible for you.

Shift : Monday-Friday, 1st - 2 positions

Job Description

Key Responsibilities :

Technical Leadership & Method Lifecycle

• Lead method development, transfer, qualification, and validation (ICH / USP / EP).
• Drive method optimization, technology scouting, and digitalization (e.g., LIMS, e-notebooks).
• Manage method control, reference standards, and critical reagent programs.

Project & Cross-Functional Support

Quality & Compliance

Laboratory & Equipment Oversight

Regulatory & Documentation

Team Leadership & Development

External Collaboration

Essential Requirements

BS in scientific discipline with 10+ years in biotech / pharma

Strong background in analytical support for biologics

Familiarity with cGMP / GLP, data integrity, and audit processes

Preferred :

The salary for this position is expected to range between $98,700 and $183,300 / 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 benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.

Salary Range

$98,700.00 - $183,300.00

Skills Desired

Agility, Analytical Development, Auditing, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Six Sigma, Sop (Standard Operating Procedure), Technological Expertise