Key Responsibilities:

Demonstrates unbossed behavior, leading analysts and senior analysts in the QC lab through technical aspects related to quality control testing readiness, including QC reagents and materials management, equipment preparation / daily cleaning and maintenance activities, sample management and QC testing, and documentation completion / review in full compliance with GMP regulations, internal procedures, and product specifications.

• Supervision of laboratory personnel, providing oversight for personnel work schedules as well as scheduling / completion of QC testing and documentation.
• Ensure personnel are appropriately trained and cross-trained before scheduling of QC tasks, while ensuring safety requirements are met and maintained.
• Provide oversight towards QC laboratory equipment maintenance.
• Maintain the laboratory and laboratory procedures/processes in a constant state of inspection readiness, supporting 5S and Lean Laboratory implementation and sustainability.
• Expertise in one or more of the following methodologies:  HPLC/UPLC, iTLC, Endotoxin, Radionuclidic identity by Half-life, Environmental Monitoring, and/or Sterility testing
• Author, review, and approve technical documents, such as SOPs, Forms, trend reports, and protocols, collaborating with other groups to drive project success.
• Provide support of laboratory related investigations, OOX results, CAPAs, and change controls.
• Oversee execution of method transfers/qualifications/validations based on Regulatory guidelines and industry best practices.
• Troubleshoot test method challenges and escalate for technical support, as needed.

Essential Requirements

• BS or MS in Biology, Chemistry, Microbiology, or other related science.
• Minimum of 5 years of relevant experience preferred in the pharmaceutical, biologics, medical device, or advanced therapy medicinal products industry.
• Previous supervisory experience is preferred.
• Current Novartis RLT and QC experience preferred.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $85,400 and $158,600/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 locations, 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.