Scientist/Principal Scientist Quality Control

Role Summary

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

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, 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.
• 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 as project needs require.
• Coach and develop staff; maintain training matrices and qualification plans.
• Oversee contract testing labs to ensure project success.
• Drive supplier qualification and negotiate service agreements.

Qualifications

• 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, LC‚ÄìMS, ICP‚ÄìMS, UV‚ÄìVis, 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

Skills

• Project management and lab startup experience
• Process improvement and data integrity mindsight

Education

• As listed under Qualifications