Novartis
Scientist/Principal Scientist Quality Control
Novartis, Durham, North Carolina, United States, 27703
Summary
The Scientist/Principal Scientist provides technical leadership and site support for current and future Quality Control operations within Novartis, including analytical method lifecycle management, regulatory submissions, QC operations, and cross‑functional initiatives across sites.
About The Role Location: Durham, NC – on‑site; no relocation support provided.
Shift: Monday–Friday.
Key Responsibilities
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.
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.
Author/review SOPs, URS, specifications, sampling plans, and validation protocols.
Own and lead GMP records such as change controls, CAPAs, investigations.
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.
Partner with Engineering, Facilities, EHS, and vendors for lab setup and equipment commissioning (URS, FAT/SAT/IOQ).
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).
May manage FTEs or contractors across multiple projects.
Coach and develop staff; maintain training matrices and qualification plans.
Oversee contract testing labs; drive supplier qualification and negotiate service agreements.
Essential Requirements
Education & Experience: BS in a 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, LC‑MS, ICP‑MS, UV‑Vis, 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.
Benefits and Compensation Base pay range: $98,700.00 / yr – $183,300.00 / yr. The final salary offered is determined based on relevant skills and experience. Compensation includes a performance‑based cash incentive and, depending on the level, eligibility for annual equity awards.
US‑based eligible employees receive a comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, and a generous time‑off package.
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.
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 & 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 hr@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.
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About The Role Location: Durham, NC – on‑site; no relocation support provided.
Shift: Monday–Friday.
Key Responsibilities
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.
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.
Author/review SOPs, URS, specifications, sampling plans, and validation protocols.
Own and lead GMP records such as change controls, CAPAs, investigations.
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.
Partner with Engineering, Facilities, EHS, and vendors for lab setup and equipment commissioning (URS, FAT/SAT/IOQ).
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).
May manage FTEs or contractors across multiple projects.
Coach and develop staff; maintain training matrices and qualification plans.
Oversee contract testing labs; drive supplier qualification and negotiate service agreements.
Essential Requirements
Education & Experience: BS in a 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, LC‑MS, ICP‑MS, UV‑Vis, 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.
Benefits and Compensation Base pay range: $98,700.00 / yr – $183,300.00 / yr. The final salary offered is determined based on relevant skills and experience. Compensation includes a performance‑based cash incentive and, depending on the level, eligibility for annual equity awards.
US‑based eligible employees receive a comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, and a generous time‑off package.
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.
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 & 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 hr@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.
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