Manager, QC Cell Based Assays Position Available In Durham, North Carolina

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 testing is performed in alignment with all relevant quality standards, and ensuring appropriate Quality Control processes, policies, and standard operating procedures to achieve the company’s objectives are met.

Key Responsibilities:

Responsible for oversight and timely, accurate and GMP compliant testing of required samples. Including the review and approval and generation of Certificate of Analysis, as required.

Acts as a subject matter expert for Quality Control related activities during regulatory inspections and as the document owner for procedures in support of the Quality Control labs.

Program management, technical writing, training, metrics, and investigations.

Participates effectively, as QC subject matter expert, with site functional teams including Manufacturing, Quality Assurance, Supply Chain and MS&T to achieve company objectivesExecutes proper investigation into the root cause of product and/or process failures and assists in determining appropriate product disposition and/or process improvements.

Ensures that any results generated by internal and external laboratories, are in compliance with GMP.Ensures that internal and external laboratories comply with cGMP standards.

Reviews and approves qualification/validation and routine testing documentation.

Contribute to Site financial /business goals.

Other duties for which QC is responsible, as assigned.

Requirements:

Bachelor’s Degree in Chemistry, Biology or related sciences with 8 years of experience in pharmaceutical industry with 2 years of direct supervisory experience.

Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands- on approach that emphasizes teamwork, collaboration, influencing, motivating, and consensus and team building.

Strong critical thinking, deductive reasoning, and decision-making skills.

Strong understanding of material sampling, analytical techniques, manufacturing operations, GMPs and the principles behind them.

Understanding of laboratory equipment such as ddPCR, qPCR, UPLC/HPLC, ICP-MS, UV/Vis Spectrophotometer, Densitometer, Gel Imager, pH, Osmometer, with specific focus on Cell based methods, Microbiology methods, etc.

Strong ability to work independently and effectively, prioritizing and delivering on tight timelines.

Novartis Compensation and Benefit Summary:

The pay range for this position at commencement of employment is expected to be between $108,500-$201,500/year; 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.