QC Analyst, Cell-based methods

Summary

This role will support activities within the Quality Control department, with a focus on cell-based methods such as Adventitious Agents, rcAAV, potency, etc. This role will utilize laboratory skills to test and measure product or materials while ensuring that analysis is performed according to established Standard Operating Procedures (SOPs), QC Methods & current Compendia.

This role is based 100% on-site.

Location: Durhan, NC

Shift: 1st, some nights and weekend work may be required

About The Role

Key Responsibilities:

• Executes routine and non-routine analysis for cGMP release and characterization testing using techniques including but not limited to cell-based methods (potency, AA), PCR (ddPCR, qPCR), Immunoassays (ELISA), chromatography (HPLC-UV, HPLC-ELSD, HPLC-MS), AUC, compendial assays (Bioburden, pH) and electrophoresis (CE, Western Blot)
• Ensures assigned to specific disciplines, but will support all necessary laboratory and assay functions, including housekeeping, safety, logbook/equipment use and maintenance, and updates to existing and authors new operating procedures.
• Capable of delivering to assigned work schedule with attention to detail and accuracy.
• Notifies management, initiates (such as Laboratory Investigations) and authors minor events/discrepancies in the quality systems, with little to no guidance from advisor or management.
• Understands the basic process improvement methodologies, learning and applying concepts of lean lab and six sigma that are applicable to the QC lab environment.
• May facilitate training to other team members in the organization.
• Ensures calibrates and maintains lab and analytical equipment are performed within established period.
• Conducts review of logbooks and may perform reviews as assigned by management
• May assist in drafting technical documents such as Protocols / Report to support method verification/validations.
• Other related job duties as assigned
  
  

Essential Requirements

• Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field.
• Learns to use professional concepts.
• Applies company policies and procedures to resolve routine issues.
• Ability to communicate and work in a team environment.
• Normally receives detailed instructions on all work.
  
  

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $27.79 and $51.58/hour; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

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 [email protected] 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.