Job Description

QC Supervisor

The QC Supervisor is responsible for day-to-day oversight of Quality Control chemical and microbiological testing of Finished Product, Raw Materials, and Packaging components, as well as oversight over maintenance for quality control instrumentation in accordance with cGMP/FDA regulations, internal standard operating procedures, and policies. This role also includes people leadership responsibilities for one shift in the QC operations group. Due to the nature of the radioactive process, this role requires proficiency of quality control techniques, analytical instrumentation, sterility principles, and an understanding of radiation safety standards.

Shift: Wednesday - Saturday PM (3 pm to 1 am) Location: Millburn, NJ

This role is located on-site in Millburn, NJ. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

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, fluctuations in the job market may necessitate adjustments to pay ranges during this period. 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. 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.

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 $85,400.00 - $158,600.00

Skills Desired: Continued Learning, Dealing With Ambiguity, Decision Making Skills, GXP, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (QC) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management

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