Job Description Summary

The Senior Analyst, Quality Control, Cell-based methods 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 #LI-Onsite
Shift: 1st. Some night and weekend work may be required

Job Description

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 with 2 years' experience in GMP environment.
Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
Exercises judgment within defined procedures and practices to determine appropriate action including the critically thinking, troubleshooting and problem-solving skills.
Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
Excellent interpersonal, verbal and written communication skills with strong technical writing experience required and ability to work in a team environment.
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $32.12/hour and $59.62/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.

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 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

$66,800.00 - $124,000.00

Skills Desired

Agility, Audit Management, Business Partnering, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Sop (Standard Operating Procedure), Technological Expertise