Overview
Manager, QC Cell Assays Jobs in Durham, North Carolina, USA at Novartis
Position: Manager, QC Cell Based Assays
Join to apply for the Manager, QC Cell Based Assays role at Novartis.
Summary
The Manager, Quality Control is responsible for the day-to-day operations of the internal QC laboratories at the manufacturing or testing site. This includes ensuring testing is performed in alignment with all relevant quality standards, and that appropriate Quality Control processes, policies, and standard operating procedures are followed to meet the company’s objectives.
About The Role
Key Responsibilities:
Oversee and ensure timely, accurate, and GMP-compliant testing of samples, including review and approval of Certificates of Analysis.
Serve as a subject matter expert during regulatory inspections and manage documentation for QC procedures.
Manage programs, technical writing, training, metrics, and investigations.
Collaborate effectively with site teams such as Manufacturing, Quality Assurance, Supply Chain, and MS&T to achieve objectives.
Investigate root causes of product or process failures and assist in product disposition and process improvements.
Ensure laboratory results comply with GMP standards.
Review and approve qualification/validation and routine testing documentation.
Contribute to site financial and business goals.
Perform other duties as assigned related to QC.
Requirements
Bachelor’s Degree in Chemistry, Biology, or related sciences with 8 years of pharmaceutical industry experience, including 2 years of supervisory experience.
Proven leadership in a collaborative environment with a positive, hands-on approach emphasizing teamwork.
Strong critical thinking, decision-making, and deductive reasoning skills.
Deep understanding of material sampling, analytical techniques, manufacturing operations, and GMP principles.
Knowledge of laboratory equipment such as ddPCR, qPCR, UPLC/HPLC, ICP-MS, UV/Vis Spectrophotometer, Densitometer, Gel Imager, pH meters, Osmometers, especially for Cell-based and Microbiology methods.
Ability to work independently, prioritize tasks, and meet tight deadlines.
Compensation & Benefits:
The salary range is estimated between $108,500 and $201,500/year, with potential additional benefits including bonuses, stock units, and comprehensive health and retirement plans, depending on location and experience.
Why Novartis:
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Equal Opportunity & Accommodations:
Novartis is committed to diversity and providing reasonable accommodations for applicants with disabilities. Contact  or call  for assistance.
Additional Details
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Quality Assurance
Industry: Pharmaceutical Manufacturing
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Title: Manager, QC Cell Assays
Company: Novartis
Location: Durham, North Carolina, USA
Category: Quality Assurance – QA/QC (Data Analyst)
