ScientistPrincipal Scientist Quality Control

Durham, NC - USA

Yearly Salary: $ 98700 - 183300

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Band

Level 4

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

Collaborate with global AST QC site operations QA and Novartis stakeholders.
Support capacity planning lab design equipment strategy and procurement.
Lead assay transfers validations verifications and equipment qualifications.
Provide technical expertise for site planning beyond GTX as a project management support

Quality & Compliance

Author/review SOPs URS specifications sampling plans and validation protocols.
Own and lead GMP records such as Change controls CAPAs investigations etc.
Ensure inspection readiness and alignment with quality systems.
Lead investigations trend analyses and continuous improvement (Lean/Six Sigma).
Maintain data integrity (ALCOA) audit trails and audit readiness.

Laboratory & Equipment Oversight

Partner with Engineering Facilities EHS and vendors for lab setup and equipment commissioning (URS FAT/SAT/IOQ).

Regulatory & Documentation

Support regulatory filings (IND/BLA) inspections and responses.
Author and approve experimental protocols reports and submissions.
Represent QC/AST in cross-functional teams (CMC Regulatory Manufacturing).

Team Leadership & Development

May manage FTEs or contractors across multiple projects as project needs require.
Coach and develop staff; maintain training matrices and qualification plans.

External Collaboration

Oversee contract testing labs to ensure project success.
Drive supplier qualification and negotiate service agreements.

Essential Requirements

Education & Experience:
- BS in scientific discipline with 10 years in biotech/pharma
- MS with 8 years or PhD with 6 years relevant experience
- 4 years leadership experience preferred
Technical Expertise:
- Strong background in analytical support for biologics
- End-to-end method lifecycle experience
- Proficiency in techniques: HPLC/UPLC GC LCMS ICPMS UVVis FTIR KF TOC NGS STR AA rcAAV raw materials dissolution titration particle size virology biologics osmolality; microbiology/EM as applicable
- Experience with lab commissioning equipment validation and LIMS
Regulatory & Quality Systems:
- Familiarity with cGMP/GLP data integrity and audit processes
- Experience with deviations CAPA change control and document management
- Regulatory filing and agency interaction experience

Preferred:

Six Sigma/Lean experience
ISO 17025 familiarity
Project management and lab startup experience

The salary for this position is expected to range between $98700 and $183300/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.

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

$98700.00 - $183300.00

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

Required Experience:

Staff IC

BandLevel 4Job Description SummaryThe 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 Quali...