Healthcare Businesswomen’s Association
Scientist/Principal Scientist Quality Control
Healthcare Businesswomen’s Association, Raleigh, North Carolina, United States
Job Description 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 #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, 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.
Salary Information 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.
Benefits 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
#J-18808-Ljbffr
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, 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.
Salary Information 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.
Benefits 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
#J-18808-Ljbffr