Scientist/Principal Scientist Quality Control

Novartis-posted 4 days ago
Full-time • Mid Level
Onsite • Durham, NC
5,001-10,000 employees
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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

  • 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.
  • 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
  • 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
  • Familiarity with cGMP/GLP, data integrity, and audit processes
  • Experience with deviations, CAPA, change control, and document management
  • Regulatory filing and agency interaction experience
  • Six Sigma/Lean experience
  • ISO 17025 familiarity
  • Project management and lab startup experience
  • 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.
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